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Each month, we review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues at the intersection of regulation, therapeutics and law.

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Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study.
DeVito NJ, Bacon S, Goldacre B.
Lancet. 2020 Feb 1;395(10221):361-369. Epub 2020 Jan 17.
Interpretation: Compliance with the FDAAA 2007 is poor, and not improving. To our knowledge, this is the first study to fully assess compliance with the Final Rule of the FDAAA 2007. Poor compliance is likely to reflect lack of enforcement by regulators. Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help. We will maintain updated compliance data for each individual sponsor and trial at fdaaa.trialstracker.net... Read More

Estimation of Medicare Part D Spending on Insulin for Patients With Diabetes Using Negotiated Prices and a Defined Formulary.
Feldman WB, Rome BN, Lehmann LS, Kesselheim AS.  
JAMA Intern Med. 2020 Feb 3. [Epub ahead of print]
Discussion: We found that Medicare Part D could have saved up to $4.4 billion on $7.8 billion of estimated postrebate spending on 31 different insulin products across 6 classes in 2017 by using the VA formulary and prices... Read More

Changes In Health Insurance Coverage, Access To Care, And Income-Based Disparities Among US Adults, 2011-17.
Griffith KN, Jones DK, Bor JH, Sommers BD.
Health Aff (Millwood). 2020 Feb;39(2):319-326. 
The Affordable Care Act increased insurance coverage and access to care, according to numerous national studies. However, the administration of President Donald Trump implemented several policies that may have affected the act's effectiveness. It is unknown what effect these changes had on access to care... We found that the proportion of adults who were uninsured or avoided care because of cost increased by 1.2 percentage points and 1.0 percentage points, respectively, during 2017... Read More

Off-Label Coverage of High-Cost Drugs by Independent Charity Patient Assistance Programs.
Kang SY, Socal MP, Bai G, Anderson GF.
J Gen Intern Med. 2020 Feb 24. [Epub ahead of print]
Independent charity patient assistance programs are funded by pharmaceutical companies to help eligible patients cover their out-of-pocket costs for prescription drugs... We found that they frequently provided assistance for off-label uses of high-cost drugs, and almost half of these uses were not supported by any of the three widely used clinical compendia. If patient assistance programs used other criteria to determine support for off-label uses, these alternative criteria were not disclosed... Read More

New drug approvals in oncology.
Kurzrock R, Kantarjian HM, Kesselheim AS, Sigal EV.
Nat Rev Clin Oncol. 2020 Mar;17(3):140-146. Epub 2020 Feb 4. Review.
In this Viewpoint, we asked two leading oncologists involved in clinical drug development, an expert in regulatory science and prescription drug policy and a prominent patient advocate, to provide their opinions on the implications of changes in regulatory practices for patient care... Read More

Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses.
Wallach DJ, Wang K,. Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS.
BMJ. 2020 Feb 5;368:17078. 
Conclusions: The results suggest that rosiglitazone is associated with an increased cardiovascular risk, especially for heart failure events. Although increased risk of myocardial infarction was observed across analyses, the strength of the evidence varied and effect estimates were attenuated when summary level data were used in addition to individual patient level data... Read More

​ARCHIVES
2020
JANUARY 2020
​1. Darrow JJ, Avorn J, Kesselheim. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 Jan 13;323(2):164-176.
2. Desai RJ, Sarpatwari A, Gautam N, Lii J, Fischer MA, Gagne JJ. Changes in Utilization of Generic Angiotensin Receptor Blockers Following Product Recalls in the United States. JAMA. 2020 Jan;323(1):87-89.
3. Hu Y, Eynikel D, Boulet P, Krikorian G. Supplementary protection certificates and their impact on access to medicines in Europe: case studies of sofosbuvir, trastuzumab and imatinib. J Pharm Policy Pract. 2020 Jan 14;13:1.
4. Jung EH, Sarpatwari A, Kesselheim AS. Novelty of Active Ingredients in High-Cost Brand-Name Drugs. J Gen Intern Med. 2020 Jan 2. [Epub ahead of print]
5. Kaltenboeck A, Calsyn M, Frederix GWJ, Lowenthal J, Mitchell D, Rector B, Sarpatwari A. Grounding Value-Based Drug Pricing in Population Health. Clin Pharmacol Ther. 2020 Jan 17. [Epub ahead of print]
6. Kim SC, Sarpatwari A, Landon JE, Desai RJ. Utilization and Treatment Costs of Tumor Necrosis Factor Inhibitors after the Introduction of Biosimilar Infliximab in the U.S. Arthritis Rheumatol (Hoboken, NJ). 2020 Jan 13. [Epub ahead of print]
7. King AC, Schwartz LM, Woloshin S. A National Survey of the Frequency of Drug Company Detailing Visits and Free Sample Closets in Practices Delivering Primary Care. JAMA Intern Med. 2020 Jan 27. [Epub ahead of print]
​2019
December 2019
​1. Cohen PA, Bass S. Injecting Safety into Supplements - Modernizing the Dietary Supplement Law.
N Engl J Med. 2019 Dec 19;381(25):2387-2389.
​2. Feldman WB, Avorn J, Kesselheim AS. Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary. JAMA Intern Med. 2019 Dec 2. [Epub ahead of print].
​3. Hey SP. Why High Drug Pricing Is A Problem for Research Ethics. J Bioeth Inq. 2019 Dec 19. [Epub ahead of print].
​4. Heyward J, Olson L, Sharfstein JM, Stuart EA, Lurie P, Alexander GC. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: A Review. JAMA Intern Med. 2019 Dec 30. [Epub ahead of print].
​5. Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS. FDA and EMA Biosimilar Approvals. J Gen Intern Med. 2019 Dec 2. [Epub ahead of print].
​6. Khera R, Valero-Elizondo J, Das SR, Virani SS, Kash BA, de Lemos JA, Krumholz HM, Nasir K. Cost-Related Medication Nonadherence in Adults With Atherosclerotic Cardiovascular Disease in the United States, 2013 to 2017. Circulation. 2019 Dec 17;140 (25), 2067-2075. 
​7. Prasad V, Booth CM. Multiplicity in Oncology Randomised Controlled Trials: A Threat to Medical Evidence? Lancet Oncol. 2019 Dec;20 (12), 1638-1640.
​8. Vargas V, Leopold C, Castillo-Riquelme M, Darrow JJ. Expanding Coverage of Oncology Drugs in an Aging, Upper-Middle-Income Country: Analyses of Public and Private Expenditures in Chile. J Glob Oncol. 2019 Dec;5, 1-17. 

November 2019
​1. Dave CV, Patorno E, Franklin JM, Huybrechts K, Sarpatwari A, Kesselheim AS, Bateman BT. Impact of State Laws Restricting Opioid Duration on Characteristics of New Opioid Prescriptions. J Gen Intern Med. 2019 Nov;34(11):2339-2341.
​2. Egilman AC, Wallach JD, Dhruva SS, Gonsalves GS, Ross JS. ​​Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies. J Gen Intern Med. 2019 Nov;34(11):2319-2321.
​3. Hwang TJ, Sinha MS, Dave C V, Kesselheim AS.​ Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications. Mayo Clin Proc. 2019 Nov 1. pii: S0025-6196(19)30481-1. [Epub ahead of print]
​4. Kesselheim AS, Sinha MS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Avorn J, Dal Pan GJ. Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem. Drug Saf. 2019 Nov;42(11):1287-1295.
​5. Mehta SJ, Volpp KG, Troxel AB, Day SC, Lim R, Marcus N, Norton L, Anderson S, Asch DA.​ Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence (Way 2 Text): a Randomized Clinical Trial. J Gen Intern Med. 2019 Nov;34(11):2397-2404.
​6. Rathi VK, Ross JS. Modernizing the FDA’s 510(k) Pathway. N Engl J Med. 2019 Nov 14;381(20):1891-1893.
​7. Schwartz LM, Woloshin S, Lu Z, Ross KM, Tessema FA, Peter D, Kesselheim AS. Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion. Circ Cardiovasc Qual Outcomes. 2019 Nov;12(11):e006073.
​8. Solotke MT, Ross JS, Shah ND, Karaca-Mandic P, Dhruva SS. ​Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings. J Manag Care Spec Pharm. 2019 Nov;25(11):1201-1217.

​
October 2019
​1. Aboy M, Liddell K, Crespo C, Cohen IG, Liddicoat J, Gerke S, Minssen T. How does emerging patent case law in the US and Europe affect precision medicine? Nat Biotechnol. 2019 Oct;37(10):1118-1125. 
2. Bartlett VL, Dhruva SS, Shah ND, Ryan P, Ross JS. Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence. JAMA Netw Open. 2019 Oct 2;2(10):e1912869. 
3. Egilman AC, Kesselheim AS, Krumholz HM, Ross JS, Kim J, Kapczynski A. Confidentiality Orders and Public Interest in Drug and Medical Device Litigation. JAMA Intern Med. 2019 Oct 28:1-8. [Epub ahead of print] 
4. Fernandez Lynch H, Sarpatwari A, Vonderheide RH, Zettler PJ. Right to Try Requests and Oncologists' Gatekeeping Obligations. J Clin Oncol. 2019 Oct 15:JCO1901741. doi: 10.1200/JCO.19.01741. [Epub ahead of print]
5. Fralick M, Schneeweiss S, Wallis CJD, Jung EH, Kesselheim AS. Desmopressin and the risk of hyponatremia: A population-based cohort study. PLoS Med. 2019 Oct 21;16(10):e1002930. eCollection 2019 Oct. 
6. Lee TT, Solomon DH, Kesselheim AS. Fool Me Twice? The Reemergence of Rofecoxib and the Orphan Drug Act. Ann Intern Med. 2019 Oct 1. [Epub ahead of print] (PMID: 31569216)
7. Luo J, Kulldorff M, Sarpatwari A, Pawar A, Kesselheim AS. Variation in Prescription Drug Prices by Retail Pharmacy Type: A National Cross-sectional Study. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M18-1138. [Epub ahead of print] 
8. Nayak RK, Avorn J, Kesselheim AS. Public sector financial support for late stage discovery of new drugs in the United States: cohort study. BMJ. 2019 Oct 23;367:l5766. 
9. Rome BN, Kesselheim AS. Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis. Clin Infect Dis. 2019 Oct 20. pii: ciz1039. [Epub ahead of print] 
10. Vokinger KN, Kesselheim AS. Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU. BMJ Open. 2019 Oct 10;9(10):e028634. 

 September 2019
​1. Allen H, Sommers BD. Medicaid Expansion and Health: Assessing the Evidence After 5 Years. JAMA. 2019 Sep 6. [Epub ahead of print]
2. Brighthaupt SC, Stone EM, Rutkow L, McGinty EE. Effect of Pill Mill Laws on Opioid Overdose Deaths in Ohio and Tennessee: A Mixed-Methods Case Study. Prev Med (Baltim). 2019 Sep. [Epub 2019 May 29]
3. Gyawali B, Bouche G, Pantziarka P, Kesselheim AS, Sarpatwari A. Lung Cancer Survival Gains: Contributions of Academia and Industry. J Law Med Ethics. 2019 Sep 27;47(3):465-467.
4. Hernandez I, Shrank WH, Good CB, Gellad WF. Savings from the EpiPen Authorized Generic: a Retrospective Analysis of Medicaid Data. J Gen Intern Med. 2019 Sep'34(9):1682-1684.
5. Hey SP, Feldman WB, Jung EH, D'Andrea E, Kesselheim AS. Surrogate Endpoints and Drug Regulation: What is Needed to Clarify the Evidence. J Law Med Ethics. 2019 Sep;47(3):381-387.
6. Kesselheim AS, Sinha MS, Rausch P, Lu Z, Tessema FA, Lappin BM, Zhou EH, Dal Pan GJ, Zwanziger L, Ramanadham A, Loughlin A, Enger C, Avorn J, Campbell EG. Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey. J Law Med Ethics. 2019 Sep 27;47(3):430-441.

7. Tau N, Shochat T, Gafter-Gvili A, Tibau A, Amir E, Shepshelovich D. Association Between Data Sources and US Food and Drug Administration Drug Safety Communications. JAMA Intern Med. 2019 Sep. [Epub ahead of print]
8. Zhang AD, Schwartz JL, Ross JS. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015. Milibank Q. 2019 Sep;97(3):796-819.

August 2019
​1. Bourgeois FT, Kesselheim AS. Promoting Pediatric Drug Research and Labeling – Outcomes of Legislation. N Engl J Med. 2019 Aug 29;381(9):875-881. 
2. Egilman AC, Zhang AD, Wallach JD, Ross JS. Medicare Part D Spending on Single-Enantiomer Drugs Versus Their Racemic Precursors. Ann Intern Med. 2019 Aug 13. [Epub ahead of print] 
3. Gill J, Prasad V. A reality check of the accelerated approval of immune-checkpoint inhibitors. Nat Rev Clin Oncol. 2019 Aug 5. [Epub ahead of print] 
4. Growdon ME, Sacks CA, Kesselheim AS, Avorn J. Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers. JAMA Intern Med. 2019 Aug 5. [Epub ahead of print] 
5. Gyawali B, Tessema FA, Jung EH, Kesselheim AS. Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis. JAMA Netw Open. 2019 Aug 2;2(8):e199570.
6. Jeffery MM, Hooten WM, Jena AB, Ross JS, Shah ND, Karaca-Mandic P. Rates of Physician Coprescribing of Opioids and Benzodiazepines After the Release of the Centers for Disease Control and Prevention Guidelines in 2016. JAMA Netw Open. 2019 Aug 2;2(8):e198325. 
7. San-Juan-Rodriguez A, Good CB, Heyman RA, Parekh N, Shrank WH, Hernandez I. Trends in Prices, Market Share, and Spending on Self-administered Disease-Modifying Therapies for Multiple Sclerosis in Medicare Part D. JAMA Neurol. 2019 Aug 26. [Epub ahead of print] 
8. Zhai MZ, Sarpatwari A, Kesselheim AS. Why Are Biosimilars Not Living up to Their Promise in the US? AMA J Ethics. 2019 Aug 1;21(8):E668-678. 
​
 July 2019
​1. Egilman AC, Wallach JD, Dhruva SS, Gonsalves GS, Ross JS. Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies. J Gen Intern Med. 2019 July 16. [Epub ahead of print]
2. Feldman WB, Hey SP, Franklin JM, Kesselheim AS. Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys. JAMA Netw Open. 2019 July 3;2(7):e197591.
3. Hwang TJ, Dusetzina SB, Feng J, Maini L, Kesselheim AS. Price Increases of Protected-Class Drugs in Medicare Part D, relative to Inflation, 2012-2017. JAMA. 2019;322(3):267-269.
4. Kashoki M, Hanaizi Z, Yordanova S, Vesely R, Bouygues C, Llinares J, Kweder SL. A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why. Clin Pharmacol Ther. 2019 July 15. [Epub ahead of print]
5. Li DG, Najafzadeh M, Kesselheim AS, Mostaghimi A. Spending on World Health Organization essential medicines in Medicare Part D, 2011-2015: retrospective cost analysis. BMJ. 2019 July 17;366:I4257.
6. Rhee TG, Ross JS. Association Between Industry Payments to Physicians and Gabapentoid Prescribing. JAMA Intern Med. July 2019. [Epub ahead of print]
7. Sarpatwari A, DiBello J, Zakarian M, Najafzadeh M, Kesselheim AS. Competition and price among brand-name drugs in the same class: A systematic review of the evidence. PLoS Med. 2019;16(7):e1002872
8. Sarpatwari A, Kesselheim AS. Reforming the Orphan Drug Act for the 21st Century. N Engl J Med. 2019;381(2):106-108. 
9. Stern AD, Pietrulla F, Herr A, Kesselheim AS, Sarpatwari A. The Impact Of Price Regulation On The Availability Of New Drugs In Germany. Health Aff (Millwood). 2019 July;38(7):1182-1187. 
10. Zhang AD, Schwartz JL, Ross JS. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015. Millibank Q. July 2019. [Epub ahead of print]

June 2019
​1. Beall RF, Hwang TJ, Kesselheim AS. Pre-market development times for biologic versus small-molecule drugs. Nat Biotechnol. 2019 Jun 18. [Epub ahead of print]
2. Bikdeli B, Welsh JW, Akram Y, Punnanithinont N, Lee I, Desai NR, Kaul S, Stone GW, Ross JS, Krumholz HM. Non-Inferiority Designed Cardiovascular Trials in Highest-Impact Journals: Main Findings, Methodological Quality and Time Trends. Circulation. 2019 Jun 10. [Epub ahead of print] 
3. Gordon SH, Sommers BD, Wilson I, Galarraga O, Trivedi AN. The Impact of Medicaid Expansion on Continuous Enrollment: a Two-State Analysis. J Gen Intern Med. 2019 Jun 21. Epub ahead of print]
4. Largent EA, Heffernan KG, Joffe S, Lynch HF. Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies. J Clin Oncol. 2019 Jun 14:JCO1900250. [Epub ahead of print]
5. Ross JS, Rohde S, Sangaralingham L, Brito JP, Choi L, Dutcher SK, Graham DJ, Jenkins MR, Lipska KJ, Mendoza M, Qiang Y, Wang Z, Wu Y, Yao X, Shah ND. Generic and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016.J Clin Endocrinol Metab. 2019 Jun 1;104(6):2305-2314.
6. Rutkow L, McGinty MD, Wetter S, Vernick JS. Local Public Health Policymakers' Views on State Preemption: Results of a National Survey, 2018.Am J Public Health. 2019 Jun 20:e1-e4. [Epub ahead of print] 
7. Vokinger KN, Kesselheim AS. Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs. Health Policy. 2019 Jun 12. pii: S0168-8510(19)30153-8. [Epub ahead of print] 

May 2019
1. Bollyky T, Kesselheim AS. Pharmaceutical Protections in U.S. Trade Deals - What Do Americans Get in Return? N Engl J Med. 2019 May 23;380(21):1993-1995. [Epub 2019 May 1]
2. Brighthaupt SC, Stone EM, Rutkow L, McGinty EE. Effect of pill mill laws on opioid overdose deaths in Ohio & Tennessee: A mixed-methods case study. Prev Med. 2019 May 29. pii: S0091-7435(19)30198-7. [Epub ahead of print]
3. Chen EY, Raghunathan V, Prasad V. An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate. JAMA Intern Med. 2019 May 28. [Epub ahead of print]
​4. Dave CV, Brill G, Kesselheim AS. Changes in Price for Generic Drugs in the USA, 2008-2016. J Gen Intern Med. 2019 May 7. [Epub ahead of print]
​5. Gyawali B, Hey SP, Kesselheim AS. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval. JAMA Intern Med. 2019 May 28. [Epub ahead of print]
​6. Hilal T, Sonbol MB, Prasad V. Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration.  JAMA Oncol. 2019 May 2. [Epub ahead of print]
​7. Skydel JJ, Luxkaranayagm AT, Dhruva SS, Ross JS, Wallach JD. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments. ​JAMA Netw Open. 2019 May 3;2(5):e193410

April 2019
​1. Chen EY, Joshi SK, Tran A, Prasad V. Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials. JAMA Intern Med. 2019 Apr 1. [Epub ahead of print]
​2. D'Andrea E, Hey SP, Ramirez CL, Kesselheim AS. Assessment of the Role of Niacin in Managing Cardiovascular Disease Outcomes: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Apr 5;2(4):e192224. 
3. Fleischman W, Agrawal S, Gross CP, Ross JS. Association of Pharmaceutical Manufacturer Payments to Physicians and Prescribing Dosage of Opioids. J Gen Intern Med. 2019 Apr 22. [Epub ahead of print]
4. Liu S, Kesselheim AS. Experiences With and Challenges Afforded by Expedited Regulatory Pathways. Clin Pharmacol Ther. 2019 Apr;105(4):795-797.
5. Vijay A, Ross JS, Shah ND, Jeffery MM, Dhruva SS. Medicare Formulary Coverage and Restrictions for Opioid Potentiators from 2013 to 2017. J Gen Intern Med. 2019 Apr;34(4):518-520. 
​6. Wallach JD, Egilman AC, Ross JS, Woloshin S, Schwartz LM. Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis. J Gen Intern Med. 2019 Apr;34(4):492-495. 

MARCH 2019
​1. Beall RF, Hwang TJ, Kesselheim AS. Major Events in the Life Course of New Drugs, 2000-2016. N Engl J Med. 2019 Mar 14;380(11):e12.
2. Chua KP, Conti RM. Out-of-pocket Spending on Orphan Drug Prescriptions Among Commercially Insured Adults in 2014. J Gen Intern Med. 2019 Mar;34(3):338-340. 
​3. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly JG, Fischer MA, Kesselheim AS, Gagne JJ.  Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims. PLoS Med. 2019 Mar 13;16(3):e1002763. eCollection 2019 Mar. 
​4. Fleischman W, Auth D, Shah ND, Agrawal S, Ross JS. Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing. JAMA Netw Open. 2019 Mar 1;2(3):e191340.
​5. Gyawali B, Kesselheim AS. US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent? JAMA Oncol. 2019 Mar 28. [Epub ahead of print]
​6. Hernandez I, Good CB, Shrank WH, Gellad WF. Trends in Medicaid Prices, Market Share, and Spending on Long-Acting Insulins, 2006-2018. JAMA. 2019 Mar 25. [Epub ahead of print]

FEBRUARY 2019
​1. Beall RF, Kesselheim AS, Sarpatwari A. New Drug Formulations and Their Respective Generic Entry Dates. J Manag Care Spec Pharm. 2019 Feb;25(2):218-224. 
2. Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS. Impact Of The Priority Voucher Program On Drug Development For Rare Pediatric Diseases. Health Aff (Millwood). 2019 Feb;38(2):313-319. 
3. Rollman JE, Heyward J, Olson L, Lurie P, Sharfstein J, Alexander GC.  Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products. JAMA. 2019 Feb 19;321(7):676-685.
​4. San-Juan-Rodriguez A, Prokopovich MV, Shrank WH, Good CB, Hernandez I. Assessment of Price Changes of Existing Tumor Necrosis Factor Inhibitors After the Market Entry of Competitors. JAMA Intern Med. 2019 Feb 18 [Epub ahead of print] 
​5. Sarpatwari A, Curfman G.  Mitigating Health Risks of Prescription Drugs: Lessons From FDA Oversight of Opioid Products. JAMA. 2019 Feb 19;321(7):651-653. 
6. ​Thomas S, Caplan A. The Orphan Drug Act Revised. JAMA. 2019 Feb 15. [Epub ahead of print]

JANUARY 2019
​1. Fralick M, Sacks CA, Kesselheim AS. Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect. JAMA Intern Med. 2019 Jan 7. [Epub ahead of print]
2. Hernandez I, Good CB, Cutler DM, Gellad WF, Parekh N, Shrank WH. The Contribution of New Product Versus Existing Product Inflation In The Rising Costs of Drugs. Health Aff (Millwood). 2019 Jan;38(1):76-83.
3. Hwang TJ, Jain N, Lauffenburger JC, Vokinger KN, Kesselheim AS. Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs. JAMA Intern Med. 2019 Jan 14. [Epub ahead of print]
4. Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM. Physicians' Perspectives on FDA Approval Standards and Off-Label Drug Marketing. JAMA Intern Med. 2019 Jan 22. [Epub ahead of print]
5. Lloyd JT, Maresh S, Powers CA, Shrank WH, Alley DE. How Much Does Medication Nonadherence Cost the Medicare Fee-for-Service Program? Med Care. 2019 Jan 22. [Epub ahead of print]
6. Luo J, Khan NF, Manetti T, Rose J, Kaloghlian A, Gadhe B, Jain SH, Gagne JJ, Kesselheim AS. Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes. JAMA. 2019 Jan;321(4):374-384.
7. Sarpatwari A, Gagne JJ, Lu Z, Campbell EG, Carman WJ, Enger CL, Dutcher SK, Jiang W, Kesselheim AS. A Survey of Patients' Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications. J Gen Intern Med. 2019 Jan 10. [Epub ahead of print]
8. Schwartz LM, Woloshin S. Medical Marketing in the United States, 1997-2016. JAMA. 2019 Jan 1;321(1):80-96.
2018
DECEMBER 2018
​1. Beall RF, Darrow JJ, Kesselheim AS. A Method for Approximating Future Entry of Generic Drugs. Value Health. 2018 Dec;21(12):1382-1389.
​2. Danzon PM. Differential Pricing of Pharmaceuticals: Theory, Evidence and Emerging Issues. Pharmacoeconomics. 2018 Dec;36(12):1395-1405.
3. Gagne JJ, Sarpatwari A, Desai RJ. Role of Authorized Generics in Postapproval Surveillance of Generic Drug Products. Clin Pharmacol Ther. 2018 Dec 28. [Epub ahead of print]
​4. Haslam A, Hey SP, Gill J, Prasad V. A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology. Eur J Cancer. 2019 Jan;106:196-211. [Epub 2018 Dec 5]
5. Shaw DL, Dhruva SS, Ross JS. Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval. J Manag Care Spec Pharm. 2018 Dec;24(12):1230-1238.
6. Wallach JD, Egilman AC, Ross JS, Woloshin S, Schwartz LM. Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis. J Gen Intern Med. 2018 Dec 12. [Epub ahead of print]


NOVEMBER 2018
​1. Federico CA, Wang T, Doussau A, Mogil JS, Fergusson D, Kimmelman J. ​Assessment of Pregabalin Postapproval Trials and the Suggestion of Efficacy for New Indications; A Systematic Review. JAMA Intern Med. 2018 Nov 26. [Epub ahead of print]
​2. Ghosh A, Simon K, Sommers BD.  The Effect of Health Insurance on Prescription Drug Use Among Low-Income Adults: Evidence from Recent Medicaid Expansions. J Health Econ. 2018 Nov 6;63:64-80. [Epub ahead of print]
3. Gupta R, Shah ND, Ross JS. Generic Drugs in the United States: Policies to Address Pricing and Competition. Clin Pharmacol Ther. 2018 Nov 24. [Epub ahead of print]
​4. Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT. Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act. JAMA Pediatrics. 2018 Nov 19. [Epub ahead of print] 
​5. Sarpatwari A, Barenie R, Curfman G, Darrow JJ, Kesselheim AS. The US Biosimilar Market: Stunted Growth and Possible Reforms. Clin Pharmacol Ther. 2018 Nov 11. [Epub ahead of print] 

​
​OCTOBER 2018

​1. Chua KP, Conti RM. Out-of-pocket Spending on Orphan Drug Prescriptions Among Commercially Insured Adults in 2014. J Gen Intern Med. 2018 Oct 15. [Epub ahead of print]
2. Cutler DM. Extending the User Fee Approach to Pharmaceuticals. JAMA. 2018 Oct 16;320(15):1525-1526.
3. Feldman WB, Hey SP, Kesselheim AS. A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway. Health Aff (Millwood). 2018 Oct;37(10):1605-1614. 
4. Hwang TJ, Gyawali B. Association between progression-free survival and patients' quality of life in cancer clinical trials. Int J Cancer. 2018 Oct 29. [Epub ahead of print]
5. Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM. Internal Medicine Physicians' Financial Relationships with Industry: An Updated National Estimate. J Gen Intern Med. 2018 Oct 5. [Epub ahead of print]


SEPTEMBER 2018

​1. Avorn J, Kesselheim A, Sarpatwari A. The FDA Amendments Act of 2007 - Assessing Its Effects a Decade Later. N Engl J Med. 2018 Sep 20;379(12):1097-1099. 
2. Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH. Changes in Drug Pricing After Drug Shortages in the United States. Ann Intern Med. 2018 Sep 18. [Epub ahead of print] 
3. Moore TJ, Zhang H, Anderson G, Alexaner GC. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration. JAMA Intern Med. 2018 Sep 24. [Epub ahead of print]
4. Nishikawa G, Prasad V. Diagnostic expansion in clinical trials: myocardial infarction, stroke, cancer recurrence, and metastases may not be the hard endpoints you thought they were. BMJ. 2018 Sep 19;362:k3783. 
5. Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS. Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012. JAMA Intern Med. 2018 Sep 24. [Epub ahead of print] 


AUGUST 2018
​1. Brodersen J, Kramer BS, Macdonald H, Schwartz LM, Woloshin. Focusing on overdiagnosis as a driver of too much medicine. BMJ. 2018 Aug 17 [Epub ahead of print]
2. Darrow JJ, Beall RF, Kesselheim AS. The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents. Appl Health Econ Health Policy. 2018 Aug 24 [Epub ahead of print]
3. Lynch HF, Zettler PJ, Sarpatwari A. Promoting Patient Interests in Implementing the Federal Right to Try Act. JAMA. 2018 Aug 13. [Epub ahead of print] 
4. Marquart J, Chen EY, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Benefit From Genome-Driven Oncology. JAMA Oncol. 2018 Aug 1;4(8): 1093-1098. Chiang AC, Ross JS, Abernethy AP, 
5. O'Connor JM, Fessele KL, Steiner J, Seidl-Rathkopf K, Carson KR, Nussbaum NC, Yin ES, Adelson KB, Presley CJ, Gross CP. Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials. JAMA Oncol. 2018 Aug 1;4(8):e180798.
6. Sacks CA, Lee CC, Kesselheim AS, Avorn J. Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents. JAMA. 2018 Aug 21;320(7):650-656. 
7. Wang SV, Schneeweiss S, Gagne JJ, Evers T, Gerlinger C, Desai R, Najafzadeh M. Using Real-World Data to Extrapolate Evidence From Randomized Controlled Trials. Clin Pharmacol THer. 2018 Aug 14. [Epub ahead of print]


JULY 2018

​1. Beall RF, Darrow J, Kesselheim AS. Patent term restoration for top-selling drugs in the USA. Drug Discov Today. 2018 Jul 25. pii: S1359-6446(18)30141-7. [Epub ahead of print]
​2. Chan HW, Russell AM, Smith MY. What is the quality of drug safety information for patients: An analysis of REMS educational materials. Pharmacoepidemiol Drug Saf. 2018 Jul 13. [Epub ahead of print] 
​3. Gyawali B, Kesselheim AS. Reinforcing the social compromise of accelerated approval. Nat Rev Clin Oncol. 2018 Jul 3. [Epub ahead of print] 
4. Hernandez I, Prasad V, Gellad WF. Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy. JAMA Oncol. 2018 Jul 1;4(7):994-996.
​5. Liu P, Dhruva SS, Shah ND, Ross JS. Medicare Beneficiary Out-of-Pocket Costs for Generic Cardiovascular Medications Available Through $4 Generic Drug Discount Programs. Ann Intern Med. 2018 Jul 24. [Epub ahead of print] 
​6. Mundkur ML, Franklin J, Huybrechts KF, Fischer MA, Kesselheim AS, Linder JA, Landon J, Patorno E. Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015. Drug Saf. 2018 Jul 9. [Epub ahead of print] 
7. Nishikawa G, Luo J, Prasad V. A comprehensive review of exceptional responders to anticancer drugs in the biomedical literature. Eur J Cancer. 2018 Jul 27;101:143-151. [Epub ahead of print] 
8. Puthumana J, Wallach JD, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation. JAMA. 2018 Jul 17;320(3):301-303. 

​
JUNE 2018

1. Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li SX, Marinac-Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization  of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiol Drug Saf. 2018 Jun 12. [Epub ahead of print] 
​2. Bekelman JE, Joffe S. Three Steps Toward a More Sustainable Path for Targeted Cancer Drugs. JAMA. 2018 Jun 5;319(21):2167-2168. ​
3. Dhruva SS, Ross JS, Schulz WL, Krumholz HM. Fulfilling the Promise of Unique  Device Identifiers. Ann Intern Med. 2018 Jun 5. [Epub ahead of print] 
4. Fralick M, Avorn J, Franklin JM, Bartsch E, Abdurrob A, Kesselheim AS. Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety.  Gen Intern Med. 2018 Jun;33(6):792-794. ​
5. Gerrity MS, Prasad V, Obley AJ. Concerns About the Approval of Nusinersen Sodium by the US Food and Drug Administration. JAMA Intern Med. 2018 Jun 1;178(6):743-744. 
6. Wallach JD, Ross JS, Naci H. The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements. Clin Trials. 2018 Jun;15(3):219-229. ​
7. Sarpatwari A, Avorn J, Kesselheim AS. An Incomplete Prescription: President Trump's Plan to Address High Drug Prices. JAMA. 2018 June 19;319(23):2373-2374. ​

​
MAY 2018
​
1. Crossley JR, Tan TP, Smith KH, Ross JS, Merenstein DJ.  Review of Clinical Trial Settings of Drugs Commonly Used in Primary Care and Approved Between 2005 and 2012. J Gen Intern Med. 2018 May 18. [Epub ahead of print] 
2. Gill J, Obley AJ, Prasad V. ​Direct-to-Consumer Genetic Testing: The Implications of the US FDA's First Marketing Authorization for BRCA Mutation Testing. JAMA. 2018 May 18. 
3. ​Luo J, Kesselheim AS.  Delayed Generic Market Saturation After Patent Expiration--A Billion-Dollar Problem. JAMA Intern Med. 2018 May 1;178(5):721-722. 
4. Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barbard RT, Darrow JJ, Kesselheim AS. Precision Medicines Have Faster Approvals Based On Fewer and Smaller Trials Than Other Medicines. Health Aff (Millwood). 2018 May;37(5):724-731. 
5. Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS. Evaluating the Impact of the Orphan Drug Act's Seven-Year Market Exclusivity Period. Health Aff (Millwood). 2018 May;37(5):732-737. 
6. Sinha MS, Curfman GD, Carrier MA. Antitrust, Market Exclusivity, and Transparency in the Pharmaceutical Industry. JAMA. 2018 May 7. [Epub ahead of print]
7. Sinha MS, Kesselheim AS.  The Next Forum for Unraveling FDA Off-Label Marketing Rules: State and Federal Legislatures. PLoS Med. 2018 May 8;15(5). 
8. Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket Studies Required by the US Food and Drug Administration For New Drugs and Biologics Approved Between 2009 and 2012: Cross Sectional Analysis. BMJ. 2018 May 24;361. 
9. Woloshin S, Schwartz LM. Overcoming Overuse: The Way Forward is Not Standing Still. BMJ. 2018 May 22;361. 

APRIL 2018
​
1. Corrigan-Curay J, McKee AE, Stein P. Breakthrough-Therapy Designation--An FDA Perspective. N Engl J Med. 2018 Apr 12;378(15):1457-1458.
2. Darrow JJ, Avorn J, Kesselheim AS. The FDA Breakthrough-Drug Designation--Four Years of Experience. N Engl J Med. 2018 Apr 12;378(15):1444-1453.
3. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018 Apr 3;361. 
4. Goldman AL, McCormick D, Haas JS, Sommers BD. Effects of the ACA's Health Insurance Marketplaces on the Previously Uninsured: A Quasi-Experimental Analysis. Health Aff (Millwood). 2018 Apr;37(4): 591-599. 
5. Gupta R, Henkel A, Forman HP, Ross JS. The Impact of Off-Patent Drug Acquisitions on Prices. J Gen Intern Med. 2018 Apr 23. 
6. Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines. J Clin Oncol. 2018 Apr 24. [Epub ahead of print]
7. Sampat BN, Shadlen KC. Indian pharmaceutical patent prosecution: The changing role of Section 3(d). PLoS One. 2018 Apr 2;13(4). 

MARCH 2018

1. DeLoughery EP, Prasad V. The US Food and Drug Administration's use of regulator approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation. Ann Oncol. 2018 Mar 1;29(3):527-529. 
2. Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study. BMJ. 2018 Mar 19;360.
3. Hwang TJ, Tomasi PA, Bourgeois FT. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study. PLoS Med. 2018 Mar 1;15(3).
4. Lee TT, Kesselheim AS, Kapczynski A. Legal Challenges to State Drug Pricing Laws. JAMA. 2018 Mar 6;319(9):865-866. 
5. 't Hoen EF, Veraldi J, Toebes B, Hogerzeil HV. Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016. Bull World Health Organ. 2018 Mar 1;96(3):185-193. [Epub 2018 Feb 5]
6. Wagner J, Marquart J, Ruby J, Lammers A, Mailankody S, Kaestner V, Prasad V. Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study. BMJ. 2018 Mar 7;360. 

FEBRUARY 2018

​​1. Beall RF, Kesselheim AS. Tertiary Patenting on Drug-Device Combination Products in the United States. Nat Biotechnol. 2018 Feb 6;36(2):142-145.
2. Bothwell LE, Avorn J, Khan NF, Kesselheim AS. Adaptive Design Clinical Trials: A Review of the Literature and ClinicalTrials.gov. BMJ Ope. 2018 Feb 10;8(2):e018320.
3. Chang HY, Murimi I, Faul M, Rutkow L, Alexander GC. Impact of Florida's prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis. Pharmacoepidemiol Drug Saf. 2018 Feb 28. [Epub ahead of print]
4. Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS. Application and impact of run-in studies. J Gen Intern Med. 2018 Feb 15. [Epub ahead of print]
5. Klara K, Kim J, Ross JS. Direct-to-consumer broadcast advertisements for pharmaceuticals: Off-label promotion and adherence to FDA guidelines. J Gen Intern Med. 2018 Feb 26. [Epub ahead of print]
6. Powers JH, Evans SR, Kesselheim AS. Studying new antibiotics for multidrug resistant infections: Are today's patients paying for unproved future benefits? BMJ. 2018 Feb 22;360:k587.
7. Sobel RE, Bate A, Marshall J, Haynes K, Selvam N, Nair V, Daniel G, Brown JS, Reynolds RF. Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools. Pharmacoepidemiol Drug Saf. 2018 Feb 2. [Epub ahead of print]
8. Wallach JD, Ross JS. Gabapentin approvals, off-label use, and lessons for postmarketing efforts. JAMA. 2018 Feb 27;319(8):776-778.

JANUARY 2018
​
1. Egilman AC, Wallach JD, Ross JS, Dhruva SS. Medicare Spending and Potential Savings on Brand-Name Drug With Available Generic Substitutes Excluded by 2 Large Pharmacy Benefit Managers, 2012 Through 2015.  JAMA Intern Med. 2018 Jan 16. [Epub ahead of print.]
​2. Fuse Brown EC, Sarpatwari A. Removing ERISA's Impediment to State Health Reform. N Eng J Med. 2018 Jan 4. [Epub ahead of print]
3. Joffe S, Lynch HF. Federal Right-to-Try Legislation-Threatening the FDA's Public Health Mission. N Eng J Med. 2018 Jan 10. [Epub ahead of print]
​4. Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS. Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis. JMIR Public Health Surveill. 2018 Jan 5;4(1). 
5. Sommers BD, Kesselheim AS. Massachusett's Proposed Medicaid Reforms - Cheaper Drugs and Better Coverage? N Eng J Med. 2018 Jan 11;378(2):109-111.
6. Woloshin S, Schwartz LM, Bagley PJ, Blunt HB, White B. Characteristics of Interim Publications of Randomized Clinical Trials and Comparison With Final Publications. JAMA. 2018 Jan 23;319(4):404-406.
2017
DECEMBER 2017
  1. Curfman GD, Beletsky L, Sarpatwari A. Benefits, Limitations, and Value of Abuse-Deterrent Opioids. JAMA Intern Med. 2017 Dec 11. [Epub ahead of print]
  2. Darrow JJ, Beall RF, Kesselheim AS. Will Inter Partes Review Speed US Generic Drug Entry? Nat. Biotechnol. 2017 Dec 8;35(12):1139-1141. 
  3. Darrow JJ, Avorn J, Kesselheim AS. Speed, Safety, and Industry Funding--From PDUFA I to PDUFA VI. N Engl Med. 2017 Dec 7;377(23):2278-2286.
  4. Dave CV, Hartzema A, Kesselheim AS. Prices of Generic Drugs Associated with Numbers of Manufacturers. N Engl J Med. 2017 Dec 28;377(36):2597-2598.
  5. Hwang TJ, Darrow JJ, Kesselheim AS. The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics. JAMA. 2017 Dec 5;318(21):2137-2138.
  6. Miller JE, Wilenzick M, Ritcey N, Ross JS, Mello MM. Measuring Clinical Trial Transparency: An Empirical Analysis of Newly Approved Drugs and Large Pharmaceutical Companies. BMJ Open. 2017 Dec 5;7(12). Epub ahead of print.
  7. Pinnow E, Amr S, Bentzen SM, Brajovic S, Hungerford L, St George DM, Dal Pan G. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014. Clin Pharmacol Ther. 2017 Dec 20. Epub ahead of print
  8. Samuels EA, Ross JS, Dhruva SS. Medicare Formulary Coverage Restrictions for Prescription Opioids, 2006 to 2015. Ann Intern Med. 2017 Dec 19;167(12):895-896.​

NOVEMBER 2017
  1. Fralick M, Kesselheim AS, Avorn J, Schneeweiss S. Use of Health Care Databases to Support Supplemental Indications of Approved Medications.  JAMA Intern Med. 2017 Nov 20. Epub ahead of print. 
  2. Hakim A, Gupta R, Ross JS. High Costs of FDA Approval for Formerly Unapproved Marketed Drugs. JAMA. 2017 Nov 13. Epub ahead of print.
  3. Horton DB, Gerhard T, Davidow A, Strom BL.  Impact of the Black Triangle Label on Prescribing of New Drugs in the United Kingdom: Lessons for the United States at a Time of Deregulation. Drug Saf. 2017 Nov;26(11):1307-1313.  
  4. Kim J, Ross JS, Kapczynski A. Pediatric Exclusivity and Reuglatory Authority: Implications of Amgen v HHS. JAMA. 2017 Nov 8. Epub ahead of print. 
  5. Rutkow L, Vernick JS. Emergency Legal Authority and the Opioid Crisis. N Engl J Med. 2017 Nov 15. Epub ahead of print. 
  6. Sarpatwari A, Gluck AR, Curfman GD. The Supreme Court Ruling in Sandoz v. Amgen: A Victory for Follow-on Biologics. JAMA Intern Med. 2017 Nov 13. Epub ahead of print. ​

OCTOBER 2017
  1. Gordon N, Stemmer SM, Greenberg D, Goldstein DA. Trajectories of Injectable Cancer Drug Costs After Launch in the United States. J Clin Oncol. 2017 Oct 10. Epub ahead of print.
  2. Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.  J Manag Care Spec Pharm. 2017 Oct;23(10): 1066-1076.
  3. Jonker CJ, van der Berg HM, Kwa MSG, Hoes AW, Mol PGM.  Registries Supporting New Drug Applications. Pharmacoepidemiol Drug Saf. 2017  Oct 6. Epub ahead of print. 
  4. Sarpatwari A, Choudhry NK.  Recalibrating Privacy Protections to Promote Patient Engagement. N Engl J Med. 2017 Oct 19;377(16):1509-1511​.
​
SEPTEMBER 2017
  1. Bucher Bartelson B, Le Lait MC, Green JL, Cepeda MS, Coplan PM, Maziere JY, Wedin GP, Dart RC. Changes in Misuse and Abuse of Prescription Opioids Following Implementation of Extended-Release and Long-Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy. Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1061-1070. Epub 2017 Jul 31. 
  2. Hey SP, Cohen IG, Adashi EY, Kesselheim AS. Influence, Integrity, and the FDA: An Ethical Framework. Science. 2017 Sep 1;357(6354):876-877.
  3. Kesselheim AS, Sinha MS, Avorn J. Determinants of Market Exclusivity for Prescription Drugs in the United States. JAMA Intern Med. 2017 Nov 1;177(11):1658-1664. Epub 2017 Sep 11. 
  4. Mostaghim SR, Gagne JJ, Kesselheim AS. Safety Related Label Changes from New Drugs After Approval in the US through Expedited Regulatory Pathways: Retrospective Cohort Study. BMJ. 2017 Sep 7;358:j3837.
  5. Woloshin S, Schwartz LM, White B, Moore TJ. The Fate of FDA Postapproval Studies. N Engl J Med. 2017 Sep 21;377(12):1114-1117.
  6. Kashoki M, Lee C, Stein P. Letter to the Editor: FDA Oversight of Postmarketing Studies. N Engl J Med. 2017 Sep 21;377(12):1201-1202. 
  7. Zeitoun JD, Baron G, Vivot A, Atal I, Downing NS, Ross JS, Ravaud P. Post-Marketing Research and Its Outcome for Novel Anticancer Agents Approved by Both the FDA and EMA Between 2005 and 2010: A Cross-Sectional Study. Int J Cancer. 2017 Sep 20. Epub ahead of print. ​

AUGUST 2017
  1. Alexander GC, Ballreich J, Socal MP, Karmarkar T, Trujillo A, Greene J, Sharfstein J, Anderson G. Reducing Branded Prescription Drug Prices: A Review of Policy Options. Pharmacotherapy. 2017 Aug 14. Epub ahead of print. 
  2. Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study. Ann Intern Med. 2017 Aug 1;167(3):145-151.
  3. Horton DB, Gerhard T, Davidow A, Strom BL. Impact of the Black Triangle Label on Prescribing of New Drugs in the United Kingdom: Lessons for the United States at a Time of Deregulation. Pharmacoepidemiol Drug Saf. 2017 Aug 31. Epub ahead of print. 
  4. Hwang TJ, Franklin JM, Kesselheim AS. Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development. Clin Pharmacol Ther. 2017 Aug;102(2):290-296. 
  5. Naci H, Smalley KR, Kesselheim AS. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. JAMA. 2017 Aug 15;318(7):626-636.
  6. Sommers BD, Gawande AA, Baicker K. Health Insurance Coverage and Health--What the Recent Evidence Tells Us. N Eng J Med. 2017 Aug 10;377(6):586-593. 
  7. Zheng SY, Dhruva SS, Redberg RF. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. JAMA. 2017 Aug 15;318(7):619-625. 

JULY 2017
  1. Bonnie RJ, Kesselheim AS, Clark DJ. Both urgency and balance needed in addressing opioid epidemic: a report from the National Academies of Sciences, Engineering, and Medicine. JAMA. 2017 Aug 1;318(5):423-424. [Epub ahead of print]
  2. Fralick M, Avorn J, Kesselheim AS. The price of crossing the border for medications. N Eng J Med. 2017 Jul 27;377(4):311-313.
  3. Hwang TJ, Kesselheim AS, Sarpatwari A. Value-based pricing and state reform of prescription drug costs.  JAMA. 2017 Jul 10. [Epub ahead of print]
  4. Jain N, Hwang TJ, Franklin JM, Kesselheim AS. Association of the priority review voucher with neglected tropical disease drug and vaccine development. JAMA. 2017 Jul 25;318(4):388-389.
  5. Kemp R, Prasad V. Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused? BMC Med. 2017 Jul 21;15(1):134.
  6. Miller JE, Ross JS, Moch KI, Caplan AL. Characterizing expanded access and compassionate use programs for experimental drugs. BMC Res Notes. 2017 Jul 28;10(1):350.
  7. Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials. 2017 Jul 18;18(1):333.

JUNE 2017
  1. Chimonas S, DeVito NJ, Rothman DJ. Bringing Transparency to Medicine: Exploring Physicians' Views and Experiences of the Sunshine Act. Am J Bioeth. 2017;17(6):4-18.
  2. Dong K, Boehm G, Zheng Q. Economic Impacts of the Generic Drug User Fee Act Fee Structure. Value Health. 2017;20(6):792-8.
  3. ​ Hey SP, Franklin JM, Avorn J, Kesselheim AS. Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors. Circ Cardiovasc Qual Outcomes. 2017 Jun;10(6).
  4. Huybrechts KF, Kesai RJ, Park M, Gagne JJ, Najafzadeh M, Avorn J. The Potential Return on Public Investment in Detecting Adverse Drug Effects. Med Care. 2017;55(6):545-51.​​
  5. ‘t Hoen EFM, Boulet P, Baker BK. Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation. J Pharm Policy Pract. 2017 Jun 28;10:19.

MAY 2017
  1. Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA. 2017 May 9;317(18):1854-1863.
  2. Gellad WF, Kesselheim AS. Accelerated Approval and Expensive Drugs - A Challenging Combination. N Engl J Med. 2017 May 25;376(21):2001-2004.
  3. Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ. 2017 May 3;357:j1680.
  4. Sacks CA, Avorn J, Kesselheim AS. The Failure of Solanezumab - How the FDA Saved Taxpayers Billions. N Engl J Med. 2017 May 4;376(18):1706-1708.
  5. Sommers BD, Maylone B, Blendon RJ, Orav EJ, Epstein AM. Three-Year Impacts of the Affordable Care Act: Improved Medical Care and Health Among Low-Income Adults. Health Aff (Millwood). 2017 Jun 1;36(6): 1119-1128.

APRIL 2017
  1. Davies BJ, Hwang TJ, Kesselheim AS. Ensuring Access to Injectable Generic Drugs – The Case of Intravesical BCG for Bladder Cancer. N Engl J Med. 2017;376(15):1401-3.
  2. Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents – FDA versus EMA, 2011-2015. N Engl J Med. 2017;376(14):1386-7.
  3. Fralick M, Kesselheim AS. FDA Approval of Desmopressin for Nocturia. JAMA. 2017 Apr 6. [Epub ahead of print]
  4. Gyawali B, Prasad V. Drugs that Lack Single-Agent Activity: Are They Worth Pursuing in Combination? Nat Rev Clin Oncol. 2017;14(4):193-4.
  5. Polinski JM, Howell B, Gagnon MA, Kymes SM, Brennan TA, Shrank WH. Impact of CVS Pharmacy’s Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014). Am J Public Health. 2017;107(4):556-62.
  6. Sharfstein J. Déjà Vu at the FDA. Milbank Q. 2017 Apr 4. [Epub ahead of print]

MARCH 2017
  1. Bouvy JC, Blake K, Slattery J, De Bruin ML, Arlett P, Kurz X. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013. Pharmacoepidemiol Drug Saf. 2017 Mar 26. [Epub ahead of print]
  2. Califf RM. Warning About Shortcuts in Drug Development. J Am Heart Assoc. 2017 Mar 21;6(3).
  3. Hey SP, Kesselheim AS. Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations. Hastings Cent Rep. 2017;47(2):16-20.
  4. Layton JB, Kim Y, Alexander GC, Emery SL. Association Between Direct-to-Consumer Advertising and Testosterone Testing and Initiation in the United States, 2009-2013. JAMA. 2017;317(11):1159-1166.
  5. Luo J, Kesselheim AS, Avorn J. Medicaid Expenditures and Estimated Rebates for Epinephrine Autoinjectors, 2012 to 2016. JAMA Intern Med. 2017 Mar 27. [Epub ahead of print]
  6. Prasad V, Jesus K, Mailankody S. The high price of anticancer drugs: origins, implications, barriers, solutions. Nat Rev Clin Oncol. 2017 Mar 14. [Epub ahead of print]

FEBRUARY 2017
  1. Choudhry NK, Krumme AA, Ercole PM, Girdish C, Tong AY, Khan NF, Brennan TA, Matlin OS, Shrank WH, Franklin JM. Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 27. [Epub ahead of print]
  2. Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS. Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence. Drugs. 2017 Feb 8. [Epub ahead of print]
  3. Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open. 2017;7(2):e014582.
  4. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033. [Epub ahead of print]
  5. Luo J, Kesselheim AS, Greene J, Lipska KJ. Strategies to improve the affordability of insulin in the USA. Lancet Diabetes Endocrinol. 2017;5(3):158-159.
  6. Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat Rev Drug Discov. 2017 Feb 24. [Epub ahead of print]
  7. Spelsberg A, Prugger C, Doshi P, Ostrowski K, Witte T, Hüsgen  D, Keil U. Working Group on Health and Working Group on Freedom of Information, Transparency International Deutschland eV. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ. 2017;356:j337.
  8. Wong J, Motulsky A, Abrahamowicz M, Eguale T, Buckeridge DL, Tamblyn R. Off-label indications for antidepressants in primary care: descriptive study of prescriptions from an indication based electronic prescribing system. BMJ. 2017;356:j603.
 
JANUARY 2017
  1. Ahn R, Woodbridge A, Abraham A, Saba S, Korenstein D, Madden E, Boscardin WJ, Keyhani S. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study. BMJ. 2017;356:i6770.
  2. Califf RM. Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance. JAMA. 2017 Jan 20. [Epub ahead of print]
  3. Hakim A, Ross JS. High Prices for Drugs With Generic Alternatives: The Curious Case of Duexis. JAMA Intern Med. 2017 Jan 23. [Epub ahead of print]
  4. Kesselheim AS, Rome BN, Sarpatwari A, Avorn J. Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers. Health Aff (Millwood). 2017 Jan 18. [Epub ahead of print]
  5. Kesselheim AS, Treasure CL, Joffe S. Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage. PLoS Med. 2017;14(1):e1002190.
  6. Rose SL, Highland J, Karafa MT, Joffe S. Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest. JAMA Intern Med. 2017 Jan 17. [Epub ahead of print]
  7. Saavedra K, O’Connor B, Fugh-Berman A. Pharmacist-industry relationships. Int J Pharm Pract. 2017 Jan 18. [Epub ahead of print]
2016
DECEMBER 2016
  1. Califf RM, Robb MA, Bindman AB, Briggs JP, Collins FS, Conway PH, et al. Transforming Evidence Generation to Support Health and Health Care Decisions. N Engl J Med. 2016;375(24):2395-2400.
  2. Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone – Risks to Efforts to Stem Overdose Deaths. N Engl J Med. 2016;375(23):2213-2215.
  3. Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M. Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan. Clin Pharmacol Ther. 2016;100(6):626-632.
  4. Knopf K, Baum M, Shimp WS, Bennett CL, Faith D, Fishman ML, Hrushesky WJ. Interpretation of surrogate endpoints in the era of the 21st Century Cures Act. BMJ. 2016;355:i6286.
  5. Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016;375(24):2313-2315.
  6. Sinha MS, Kesselheim AS. Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorg Med Chem. 2016;24(24):6446-6451.
  7. Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016;31(12):1482-1489.

NOVEMBER 2016
  1. Abola MV, Prasad V. Industry Funding of Cancer Patient Advocacy Organizations. Mayo Clin Proc. 2016;91(11):1668-1670.
  2. Bauer SR, Redberg RF. Improving the Accelerated Pathway to Cancer Drug Approvals. JAMA Intern Med. 2016 Nov. [Epub ahead of print]
  3. Califf RM, Sherman RE, Slavitt A. Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS. JAMA. 2016 Nov 29. [Epub ahead of print]
  4. Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016 Nov 2. [Epub ahead of print]
  5. Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS. Active Surveillance of Follow-on Biologics: A Prescription for Uptake. Drug Saf. 2016 Nov 12. [Epub ahead of print]
  6. Xu J, Gill R, Cruz M, Staffa J, Lurie P. Effect of US Food and Drug Administration-Approved Pediatric Labeling on Dispensing of Extended-Release Oxycodone in the Outpatient Retail Setting. JAMA Pediatr. 2016;170(11):1103-1104.

OCTOBER 2016
  1. Dafny LS, Ody CJ, Schmitt MA. Undermining Value-Based Purchasing – Lessons from the Pharmaceutical Industry. N Engl J Med. 2016 Oct. [Epub ahead of print]
  2. Doshi P. Is this trial misreported? Truth seeking in the burgeoning age of trial transparency. 2016;355:i5543.
  3. Hwang TJ, Carpenter D, Lauffenburger JC, Wang B, Franklin JM, Kesselheim AS. Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results. JAMA Intern Med. 2016 Oct. [Epub ahead of print]
  4. Kesselheim AS, Avorn J. Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy. 2016 Oct. [Epub ahead of print]
  5. Sommers BD, Blendon RJ, Orav EJ, Epstein AM. Changes in Utilization and Health Among Low-Income Adults After Medicaid Expansion or Expanded Private Insurance. JAMA Intern Med. 2016;176(10):1501-9.
  6. Tominaga T, Miyazaki S, Oniyama Y, Weber AD, Kondo T. The Japanese Postmarketing Adverse Event Relief System: A confluence of regulatory science, the legal system, and clinical pharmacology. Clin Pharmacol Ther. 2016 Oct. [Epub ahead of print]
  7. Wang C, Kane R, Levenson M, Kelman J, Wernecke M, Lee JY, Kozlowski S, Dekmezian C, Zhang Z, Thompson A, Smith K, Wu YT, Wei Y, Chillarige Y, Ryan Q, Worrall C, MaCurdy TE, Graham DJ. Association Between Changes in CMS Reimbursement Policy and Drug Labels for Erythrocyte-Stimulating Agents With Outcomes for Older Patients Undergoing Hemodialysis Covered by Fee-for-Service Medicare. JAMA Intern Med. 2016 Oct. [Epub ahead of print]

SEPTEMBER 2016
  1. Bouvy JC, Huinink L, De Bruin ML. Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012. Pharmacoepidemiol Drug Saf. 2016;25(9):1004-14.
  2. Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016;176(9):1391-3.
  3. Kister I, Corboy JR.Reducing costs while enhancing quality of care in MS. Neurology. 2016 Sep 2. [Epub ahead of print]
  4. Kleijnen S, Lipska I, Leonardo Alves T, Meijboom K, Elsada A, Vervölgyi V, d’Andon A, Timoney A, Leufkens HG, De Boer A, Goettsch WG. Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries. Ann Oncol. 2016;27(9):1768-75.
  5. Lin D, Lucas E, Murimi IB, Jackson K, Baier M, Frattaroli S, Gielen A, Moyo P, Simoni-Wastilla L, Alexander GC. Physician attitudes and experiences with Maryland’s prescription drug monitoring program (PDMP). Addiction. 2016. [Epub ahead of print]
  6. Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M. Pharmaceuticals Licensing and Reimbursement in the European Union, United States and Japan. Clin Pharamcol Ther. 2016. [Epub ahead of print]
  7. Mailankody S, Prasad V. Thinking Systematically About the Off-Label Use of Cancer Drugs and Combinations for Patients Who Have Exhausted Proven Therapies. Oncologist. 2016;21(9):1031-2.
  8. Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016;316(10):1093-103.
  9. Xu J, Gill R, Cruz M, Staffa J, Lurie P. Effect of US Food and Drug Administration-Approved Pediatric Labeling on Dispensing of Extended Release Oxycodone in the Outpatient Retail Setting. JAMA Pediatr. 2016. [Epub ahead of print]

AUGUST 2016
  1. Chang HY, Lyapustina T, Rutkow L, Daubresse M, Richey M, Faul M, Stuart EA, Alexander GC. Impact of prescription drug monitoring programs and pill mill laws on high-risk opioid prescribers: A comparative interrupted time series analysis. Drug Alcohol Depend. 2016;165:1-8.
  2. Chambers JD, Rane PB, Neumann PJ. The impact of formulary drug exclusion policies on patients and healthcare costs. Am J Manag Care. 2016;22(8):524-31.
  3. Doshi JA, Lim R, Li P, Young PP, Lawnicki VF, State JJ, Troxel AB, Volpp KG. A Synchronized Prescription Refill Program Improved Medication Adherence. Health Aff. 2016;35(8):1504-12.
  4. Fleischman W, Agrawal S, King M, Venkatesh AK, Krumholz HM, McKee D, Brown D, Ross JS. Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. BMJ. 2016;354:i4189.
  5. Green AK, Wood WA, Basch EM. Time to Reassess the Cancer Compendia for Off-label Drug Coverage in Oncology. JAMA. 2016 Aug. [Epub ahead of print]
  6. Hey SP, Kesselheim AS. The FDA, Juno Therapeutics, and the ethical imperative of transparency. BMJ. 2016;354:i4435.
  7. Kesselheim AS, Avorn J, Sarpatwari A. The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. JAMA. 2016;316(8):858-71.
  8. Sarpatwari A, Gagne JJ. Balancing benefits and harms: privacy protection policies. Pharmacoepidemiol Drug Saf. 2016;25(8):969-71.
  9. Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016 Aug. [Epub ahead of print]

JULY 2016
  1. Gabler NB, Duan N, Raneses E, Suttner L, Ciarametaro M, Cooney E, Dubois RW, Halpern SD, Kravitz RL. No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals. Trials. 2016;17(1):320.
  2. Gagne JJ, Han X, Hennessy S, Leonard CE, Chrischilles EA, Carnahan RM, Wang SV, Fuller C, Iyer A, Katcoff H, Woodworth TS, Archdeacon P, Meyer TE, Schneeweiss S, Toh S. Successful comparison of US Food and Drug Administration Sentinel analysis tools to traditional approaches in quantifying a known drug-adverse event association. Clin Pharmacol Ther. 2016 Jul 14. [Epub ahead of print].
  3. Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016 Jul 18. [Epub ahead of print].
  4. Haffner ME. The history of orphan drug regulation – US and Beyond. Clin Pharmacol Ther. 2016 Jul 9. [Epub ahead of print].
  5. Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU. Br J Clin Pharmacol. 2016;82(1):213-26.
  6. Luo J, Kesselheim AS. Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad. AMA J Ethics. 2016;18(7):727-35.
  7. Mailankody S, Prasad V. Implications of Proposed Medicare Reforms to Counteract High Cancer Drug Prices. JAMA. 2016;316(3):271-2.
  8. van Staa TP, Goldacre B, Buchan I, Smeeth L. Big health data: the need to earn public trust. BMJ. 2016 Jul 14;354:i3636.

JUNE 2016
  1. Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the Gold Standard–Lessons from the History of RCTs. N Engl J Med. 2016;374(22):2175-81.
  2. Gellad WF, Good CB. Prescription of Brand-Name Medications When Generic Alternatives Are Available-Patently Unfair. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
  3. Hwang TJ, Sokolov E, Franklin JM,  Kesselheim AS. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ. 2016;353:i3323.
  4. Ioannidis JP. Why Most Clinical Research Is Not Useful. PLoS Med. 2016;13(6):e1002049.
  5. Kesselheim AS, Gagne JJ, Eddings W, Franklin JM, Ross KM, Fulchino LA, Campbell EG. Prevalence and Predictors of Generic Drug Skepticism Among Physicians: Results of a National Survey. JAMA Intern Med. 2016;176(6):845-7.
  6. Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG. Variations in Patients’ Perceptions and Use of Generic Drugs: Results of a National Survey. J Gen Intern Med. 2016;31(6):609-14.
  7. Luo J, Seeger JD, Donneyong M, Gagne JJ, Avorn J, Kesselheim AS. Effect of Generic Competition on Atorvastatin Prescribing and Patients’ Out-of-Pocket Spending. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
  8. Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):713-8.
  9. Quesada O, Yang E, Redberg RF. Availability and Dissemination of Results From US Food and Drug Administration-Mandated Postapproval Studies for Medical Devices. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
  10. Sarpatwari A, Kesselheim AS. Navigating the Dermatological Drug Cost Curve. JAMA. 2016;315(24):2724-5.
  11. Sarpatwari A, Avorn J, Kesselheim AS. State Initiatives to Control Medication Costs–Can Transparency Legislation Help? N Engl J Med. 2016;374(24):2301-4.
  12. Schwartz LM, Woloshin S, Zheng E, Tse T, Zarin DA. ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials. Ann Intern Med. 2016 Jun 14. [Epub ahead of print]

MAY 2016
  1. Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015. Ann Intern Med. 2016 May 31. [Epub ahead of print]
  2. Eichler HG, Hurts H, Broich K, Rasi G. Drug Regulation and Pricing–Can Regulators Influence Affordability? New Engl J Med. 2016 May 12;374(19):1807-9.
  3. Hey SP, Weijer C. What questions can a placebo answer? Monash Bioeth Rev. 2016 May 17. [Epub ahead of print]
  4. Kapczynski A, Kesselheim AS. ‘Government Patent Use’: A Legal Approach To Reducing Drug Spending. Health Aff. 2016 May 1;35(5):791-7.
  5. Kim C, Prasad V. Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration’s Approval of Oncology Drugs. Mayo Clin Proc. 2016 May 10. [Epub ahead of print]
  6. Outterson K, McDonnell A. Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy. Health Aff. 2016 May 1;35(5):784-90.
  7. Patel MS, Day SC, Halpern SD, Hanson CW, Martinez JR, Honeywell S Jr, Volpp KG. Generic Medication Prescription Rates After Health System-Wide Redesign of Default Options Within the Electronic Health Record. JAMA Intern Med. 2016 May 9. [Epub ahead of print]
  8. Yeh JS, Franklin JM, Avorn J, Landon J, Kesselheim AS. Association of Industry Payments to Physicians With the Prescribing of Brand-name Statins in Massachusetts. JAMA Intern Med. 2016 May 9. [Epub ahead of print]

APRIL 2016
  1. Califf RM, Woodcock J, Ostroff S. A Proactive Response to Prescription Opioid Abuse. N Engl J Med. 2016 Apr 14;374(15):1480-5.
  2. Goldacre B, Gray J. OpenTrials: towards a collaborative open database of all available information on all clinical trials. 2016 Apr 8;17(1):164.
  3. Kesselheim AS, Woloshin S, Eddings W, Franklin JM, Ross KM, Schwartz LM. Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation. 2016 Apr 12;315(14):1516-8.
  4. Rex JH, Outterson K. Antibiotic reimbursement in a model delinked from sales: a benchmark-based worldwide approach. Lancet Infect Dis. 2016 Apr;16(4):500-5.
  5. Woloshin S, Schwartz LM. US Food and Drug Administration Approval of Flibanserin: Even the Score Does Not Add Up. JAMA Intern Med. 2016 Apr 1;176(4):439-42.

MARCH 2016
  1. Hey SP, Kesselheim AS. An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion. PLoS Med. 2016 Mar 15;13(3):e1001978.
  2. Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of post-marketing studies of conditionally authorised medicines in the EU. Br J Clin Pharmacol. 2016 Mar 18. [Epub ahead of print].
  3. Kapczynski A. Free Speech and Pharmaceutical Regulation-Fishy Business. JAMA Intern Med. 2016 Mar 1;176(3):295-6.
  4. Massey PR, Wang R, Prasad V, Bates SE, Fojo T. Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting. 2016 Mar;21(3):261-8.
  5. Qato DM, Wilder J, Schumm LP, Gillet V, Alexander GC. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011. JAMA Intern Med. 2016 Mar 21. [Epub ahead of print]
  6. Yeh JS, Sarpatwari A, Kesselheim AS. Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels. Drug Saf. 2016 Mar 21. [Epub ahead of print]

FEBRUARY 2016
  1. Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. 2016 Feb 17;352:i637.
  2. Doshi P, Jefferson T. Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency. 2016 Feb 11;17(1):78.
  3. Hwang TJ, Kesselheim AS. Vaccine Pipeline Has Grown During The Past Two Decades With More Early-Stage Trials From Small And Medium-Size Companies. Health Aff (Millwood). 2016 Feb 1;35(2):219-26.
  4. Kesselheim AS, Gagne JJ Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG. Variations in Patients’ Perceptions and Use of Generic Drugs: Results of a National Survey. J Gen Intern Med. 2016 Feb 16. [Epub ahead of print]
  5. Lyapustina T, Rutkow L, Chang HY, Daubresse M, Ramji AF, Faul M, Stuart EA, Alexander GC. Effect of a “pill mill” law on opioid prescribing and utilization: The case of Texas. Drug Alcohol Depend. 2016 Feb 1;159:190-7.
  6. Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Saf. 2016 Feb 10. [Epub ahead of print]
  7. Phillips AT, Rathi VK, Ross JS. Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study. JAMA Intern Med. 2016 Feb 22. [Epub ahead of print]
  8. Sarpatwari A, Kesselheim AS. The Case for Reforming Drug Naming: Should Brand Name Trademark Protections Expire upon Generic Entry? PLoS Med. 2016 Feb 9;13(2):e1001955.

JANUARY 2016
  1. Arnold DG, Troyer JL. Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation? J Health Polit Policy Law. 2016 Jan 5. [Epub ahead of print].
  2. Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Jan;17(1):31.
  3. Choudhry NK, Denberg TD, Qaseem A; Clinical Guidelines Committee of the American College of Physicians. Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med. 2016;164(1):41-9.
  4. Greene JA, Anderson G, Sharfstein JM. Role of the FDA in Affordability of Off-Patent Pharmaceuticals. 2016 Jan 4. [Epub ahead of print].
  5. Kesselheim AS, Hwang TJ. Breakthrough Medical Devices and the 21st Century Cures Act. Ann Intern Med. 2016 Jan 19. [Epub ahead of print].
  6. Lieberman DA, Polinski JM, Choudhry NK, Avorn J, Fischer MA. Medicaid prescription limits: policy trends and comparative impact on utilization. BMC Health Serv Res. 2016;16(1):15.
  7. Vilhelmsson A, Davis C, Mulinari S. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012. PLoS Med. 2016;13(1):e1001945.
  8. Wu MH, Bartz D, Avorn J, Seeger JD. Trends in Direct-to-Consumer Advertising of Prescription Contraceptives. 2016 Jan 22. [Epub ahead of print].
2015
DECEMBER 2015
  1. Dhruva SS, Prasad V. Application of Medicare’s New Technology Add-on Payment Program for Blinatumomab. JAMA Oncol. 2015 Dec 30:1-2. [Epub ahead of print].
  2. Hunter NL, O’Callaghan KM, Califf RM. Engaging Patients Across the Spectrum of Medical Product Development: View From the US Food and Drug Administration. 2015 Dec 15;314(23):2499-500.
  3. Langedijk J, Whitehead CJ, Slijkerman DS, Leufkens HG, Schutjens MD, Mantel-Teeuwisse AK. Extensions of indication throughout the drug product lifecycle: a quantitative analysis. Drug Discov Today. 2015 Dec 2. [Epub ahead of print].
  4. Neumann PJ, Cohen JT. Measuring the Value of Prescription Drugs. N Engl J Med. 2015 Dec 31;373(27):2595-7.
  5. Shaw DL, Ross JS. US Federal Government Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing. AMA J Ethics. 2015 Dec 1;17(12):1152-9.
  6. Treasure CL, Avorn J, Kesselheim AS. Do March-In Rights Ensure Access to Medical Products Arising From Federally Funded Research? A Qualitative Study. Milbank Q. 2015 Dec;93(4):761-87.
  7. Yeh JS, Austad KE, Franklin JM, Chimonas S, Campbell EG, Avorn J, Kesselheim AS. Medical Schools’ Industry Interaction Policies Not Associated With Trainees’ Self-Reported Behavior as Residents: Results of a National Survey. J Grad Med Educ. 2015 Dec;7(4):595-602.

NOVEMBER 2015
  1. Årdal C, Outterson K, Hoffman SJ, Ghafur A, Sharland M, Ranganathan N, Smith R, Zorzet A, Cohn J, Pittet D, Daulaire N, Morel C, Rizvi Z, Balasegaram M, Dar OA, Heymann DL, Holmes AH, Moore LS, Laxminarayan R, Mendelson M, Røttingen JA. International cooperation to improve access to and sustain effectiveness of antimicrobials. Lancet. 2015 Nov 17. [Epub ahead of print].
  2. Eguale T, Buckeridge DL, Verma A, Winslade NE, Benedetti A, Hanley JA, Tamblyn R. Association of off-label drug use and adverse drug events in an adult population. JAMA Intern Med. 2015 Nov 2. [Epub ahead of print].
  3. Gagne JJ, Kesselheim AS, Choudhry NK, Polinski JM, Hutchins D, Matlin OS, Brennan TA, Avorn J, Shrank WH. Comparative effectiveness of generic versus brand-name antiepileptic medications. Epilepsy Behav. 2015;52(Pt A):14-8.
  4. Hung A, Sieluk J, Doshi P. The untapped potential of pharmacy leaflets for informing patients about drug benefits and risks. JAMA Intern Med. 2015 Nov 30. [Epub ahead of print].
  5. Kesselheim AS, Hwang TJ, Franklin JM. Two decades of new drug development for central nervous system disorders. Nat Rev Drug Discov. 2015 Nov 20. [Epub ahead of print].
  6. Krishnamurti T, Woloshin S, Schwartz LM, Fischhoff B. A randomized trial testing US Food and Drug Administration “breakthrough” language. JAMA Intern Med. 2015;175(11):1856-8.
  7. Palasik B, Sieluk J, dosReis S, Doshi P. Stimulant use and cardiovascular risk among children and adolescents with ADHD: what product labeling does, or does not, tell us. Value Health. 2015;18(7):A747.

OCTOBER 2015
  1. Abola MV, Prasad V. The Use of Superlatives in Cancer Research. JAMA Oncol. 2015 Oct 29. [Epub ahead of print].
  2. Downing NS, Krumholz HM, Ross JS, Shah ND. Regulatory watch: Characterizing the US FDA’s approach to promoting transformative innovation. Nat Rev Drug Discov. 2015 Oct 5. [Epub ahead of print].
  3. Ioannidis JP, Fanelli D, Dunne DD, Goodman SN. Meta-research: Evaluation and Improvement of Research Methods and Practices. PLoS Biol. 2015 Oct 2; 13(10):e1002264.
  4. Kesselheim AS, Maggs LR, Sarpatwari A. Experience With the Priority Review Voucher Program for Drug Development. JAMA. 2015 Oct 27; 314(16):1687-8.
  5. Kim C, Prasad V. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals. JAMA Intern Med. 2015 Oct 19. [Epub ahead of print].
  6. Langedijk J, Ebbers HC, Mantel-Teeuwisse AK, Kruger-Peters AG, Leufkens HG. Licensing failure in the European decentralised procedure. Eur J Pharm Sci. 2015 Oct 19. [Epub ahead of print].
  7. Luo J, Kesselheim AS. Evolution of insulin patents and market exclusivities in the USA. Lancet Diabetes Endocrinol. 2015 Oct 6. [Epub ahead of print].
  8. Whicher DM, Miller JE, Dunham KM, Joffe S. Gatekeepers for pragmatic clinical trials. Clin Trials. 2015 Oct; 12(5):442-8.

SEPTEMBER 2015
  1. Anderson TS, Good CB, Gellad WF. Prevalence and compensation of academic leaders, professors, and trustees on publicly traded US healthcare company boards of directors: cross sectional study. BMJ.  Sep 29 2015;351:h4826.
  2. Avorn J, Sarpatwari A, Kesselheim AS. Forbidden and Permitted Statements about Medications–Loosening the Rules. New Eng J Med. Sep 3 2015;373(10):967-973.
  3. Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials. Sep 15 2015. [Epub ahead of print].
  4. Doshi P. No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility. BMJ. Sep 16 2015;351:h4629.
  5. Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. Sep 23 2015;351:h4633.
  6. Kim Y, Kornfield R, Shi Y, et al. Effects of Televised Direct-to-Consumer Advertising for Varenicline on Prescription Dispensing in the United States, 2006-2009. Nicotine Tob Res. Sep 18 2015. [Epub ahead of print].
  7. Krishnamurti T, Woloshin S, Schwartz LM, Fischhoff B. A Randomized Trial Testing US Food and Drug Administration “Breakthrough” Language. JAMA Intern Med. Sep 21 2015. [Epub ahead of print].
  8. Mendes D, Alves C, Batel-Marques F. Number needed to harm in the post-marketing safety evaluation: results for rosiglitazone and pioglitazone. Pharmacoepidemiol Drug Saf. Sep 16 2015. [Epub ahead of print].
  9. Podolsky SH, Powers JH, 3rd. Regulating Antibiotics in an Era of Resistance: The Historical Basis and Continued Need for Adequate and Well-Controlled Investigations. Annals Intern Med. Sep 1 2015;163(5):386-388.
  10. Wang B, Kesselheim AS. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review. BMJ. Sep 23 2015;351:h4679.

AUGUST 2015
  1. Chambers JD, Chenoweth M, Thorat T, Neumann PJ. Private Payers Disagree With Medicare Over Medical Device Coverage About Half The Time. Health Aff (Millwood). 2015 Aug 1; 34(8):1376-82.
  2. Djulbegovic B. Value-Based Cancer Care and the Excessive Cost of Drugs. JAMA Oncol. 2015 Aug 27. [Epub ahead of print].
  3. Greene JA, Watkins ES. The Vernacular of Risk – Rethinking Direct-to-Consumer Advertising of Pharmaceuticals. N Engl J Med. 2015 Aug 19. [Epub ahead of print].
  4. Luo J, Avorn J, Kesselheim AS. Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014. JAMA Intern Med. 2015 Aug 24. [Epub ahead of print].
  5. Luo J, Kesselheim AS. The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines. JAMA. 2015 Aug 20. [Epub ahead of print].
  6. Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA. 2015 Aug 11; 314(6):604-12.
  7. Robertson CT. New DTCA Guidance – Enough to Empower Consumers? N Engl J Med. 2015 Aug 19. [Epub ahead of print].
  8. Rutkow L, Chang HY, Daubresse M, Webster DW, Stuart EA, Alexander GC. Effect of Florida’s Prescription Drug Monitoring Program and Pill Mill Laws on Opioid Prescribing and Use. JAMA Intern Med. 2015 Aug 17. [Epub ahead of print].
  9. Schick A, Miller KL, Lanthier M, Woodcock J. Regulatory watch: What drives differences in review times among CDER divisions? Nat Rev Drug Discov. 2015 Aug 21. [Epub ahead of print].

JULY 2015
  1. Campbell EG, Vogeli C, Rao SR, Abraham M, Pierson R, Applebaum S. Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014. JAMA Intern Med. 2015 Jul 13. [Epub ahead of print].
  2. Eichler HG, Thomson A, Eichler I, Schneeweiss S. Assessing the relative efficacy of new drugs: an emerging opportunity. Nat Rev Drug Discov. 2015 Jul 1; 14(7):443-4.
  3. Flacco ME, Manzoli L, Boccia S, et al. Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor. J Clin Epidemiol. 2015 Jul; 68(7):811-20.
  4. Gellad WF, Flynn KE, Alexander GC. Evaluation of Flibanserin: Science and Advocacy at the FDA. JAMA. 2015 Jul 6. [Epub ahead of print].
  5. Ma P, Marinovic I, Karaca-Mandic P. Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration. JAMA Intern Med. 2015 Jul 27. [Epub ahead of print].
  6. Sampat BN, Shadlen KC. Patent watch: Drug patenting in India: looking back and looking forward. Nat Rev Drug Discov. 2015 Jul 17. [Epub ahead of print].
  7. Sharfstein JM, Kesselheim AS. The Safety of Prescription Drugs. JAMA. 2015 Jul 21; 314(3):233-4.

JUNE 2015
  1. Avorn J. In Opposition to Liberty: We Need a “Sovereign” to Govern Drug Claims. Ann Intern Med. 2015 June 30. [Epub ahead of print]
  2. Avorn J and Kesselheim AS. The 21st Century Cures Act – Will It Take Us Back in Time? New Engl J Med. 2015 June 25;372(26):2473-2475.
  3. Doshi P. FDA drug summaries: a simplification too far? 2015 June 12; 350:h3135.
  4. Kapczynski, A. (2015). The Trans-Pacific Partnership – Is It Bad for Your Health? N Engl J Med.2015 June 10. [Epub ahead of print]
  5. Lanini S, Zumla A, Ioannidis JPA, et al. Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa? The Lancet Infectious Diseases. 2015 June;15(6):738-745.
  6. Lurie P, Chahal HS, Sigelman DW, Stacy S, Sclar J, Ddamulira B.Comparison of content of FDA letters not approving applications for new drugs and associated public announcement from sponsors: cross sectional study.  2015 June 10;350:h2758.
  7. McMahon AW, Wharton GT, Bonnel R, et al. Pediatric post-marketing safety systems in North America: assessment of the current status. Pharmacoepidemiol Drug Saf. 2015 June 22. [Epub ahead of print]
  8. Ruger JP, Ruger TW, Annas GJ. The Elusive Right to Health Care under U.S. Law. New Engl J Med. 2015 June 25;372(26):2558-2563.

MAY 2015
  1. Avorn J. The $2.6 billion pill–methodologic and policy considerations. N Engl J Med. 2015 May 14;372(20):1877-1879.
  2. Iglehart JK, Sommers BD. Medicaid at 50–from welfare program to nation’s largest health insurer. N Engl J Med. 2015 May 28;372(22):2152-2159.
  3. Ito K, Avorn J, Shrank WH, Toscano M, Spettel C, Brennan T, Choudhry NK. Long-term cost-effectiveness of providing full coverage for preventive medications after myocardial infarction. Circ Cardiovasc Qual Outcomes. 2015 May;8(3):252-259.
  4. Jena AB, Ho O, Goldman DP, Karaca-Mandic P. The Impact of the US Food and Drug Administration Chlorofluorocarbon Ban on Out-of-pocket Costs and Use of Albuterol Inhalers Among Individuals With Asthma. JAMA Intern Medicine. 2015 May 11. [Epub ahead of print]
  5. Kornfield R, Alexander GC, Qato DM, Kim Y, Hirsch JD, Emery SL. Trends in exposure to televised prescription drug advertising, 2003-2011. Am J Prev Med. 2015 May;48(5):575-579.
  6. Lexchin J. Health Canada’s use of its priority review process for new drugs: a cohort study. BMJ Open. 2015 May 11;5(5):e006816.
  7. Sarpatwari A, Avorn J, Kesselheim AS. Progress and Hurdles for Follow-on Biologics. N Engl J Med. 2015 May 6. [Epub ahead of print]

APRIL 2015
  1. Cho MK, Magnus D, Constantine M, Lee SS, Kelley M, Alessi S, Korngiebel D, James C, Kuwana E, Gallagher TH, Diekema D, Capron AM, Joffe S, Wilfond BS. Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Ann Intern Med. 2015 Apr 14. [Epub ahead of print]
  2. Daubresse M, Hutfless S, Kim Y, Kornfield R, Qato DM, Huang J, Miller K, Emery SL, Alexander GC. Effect of Direct-to-Consumer Advertising on Asthma Medication Sales and Healthcare Utilization. Am J Respir Crit Care Med. 2015 Apr 16. [Epub ahead of print]
  3. Goldacre B. How to get all trials reported: audit, better data, and individual accountability. PLoS Med. 2015 Apr 14;12(4):e1001821.
  4. Kesselheim AS, Franklin JM, Kim SC, Seeger JD, Solomon DH. Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population. J Gen Intern Med. 2015 Apr 9. [Epub ahead of print]
  5. Light DW, Lexchin J. Why do cancer drugs get such an easy ride? 2015 Apr 23;350:h2068.
  6. McClellan MB, Daniel GW, Dickson D, Perlmutter J, Berger DP, Miller V, Nussbaum S, Malin J, Romine MH, Schilsky RL. Improving evidence developed from population-level experience with targeted agents. Clin Pharmacol Ther. 2015 May;97(5):478-87. Epub 2015 Apr 3.
  7. Ross JS, Dzara K, Downing NS. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs. Health Aff (Millwood). 2015 Apr 1;34(4):681-88.

MARCH 2015
  1. Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015 Mar 12;372(11):1031-1039.
  2. Gopal AD, Desai NR, Tse T, Ross JS. Reporting of noninferiority trials in ClinicalTrials.gov and corresponding publications. JAMA. 2015 Mar 17;313(11):1163-1165.
  3. Greene JA, Riggs KR. Why is there no generic insulin? Historical origins of a modern problem. N Engl J Med. 2015 Mar 19;372(12):1171-1175.
  4. Kesselheim AS, Polinski JM, Fulchino LA, Isaman DL, Gagne JJ. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes. Drugs. 2015 Mar 31. [Epub ahead of print]
  5. Knox C, Hampp C, Willy M, Winterstein AG, Pan GD. Patient understanding of drug risks: an evaluation of medication guide assessments. Pharmacoepidemiol Drug Saf. 2015 Mar 23. [Epub ahead of print]
  6. Najafzadeh M, Andersson K, Shrank WH, Krumme AA, Matlin OS, Brennan T, Avorn J, Choudhry NK. Cost-effectiveness of novel regimens for the treatment of hepatitis C virus. Ann Intern Med. 2015 Mar 17;162(6):407-419.
  7. Parekh A, Buckman-Garner S, McCune S, ONeill R, Geanacopoulos M, Amur S, Clingman C, Barratt R, Rocca M, Hills I, Woodcock J. Catalyzing the critical path initiative: FDA’s progress in drug development activities. Clin Pharmacol Ther. 2015 Mar;97(3):221-233.
  8. Sarpatwari A, Choudhry NK, Avorn J, Kesselheim AS. Paying physicians to prescribe generic drugs and follow-on biologics in the United States. PLoS Med. 2015 Mar 17;12(3):e1001802.
  9. Weissman JS, Westrich K, Hargraves JL, Pearson SD, Dubois R, Emond S, Olufajo OA. Translating comparative effectiveness research into Medicaid payment policy: views from medical and pharmacy directors. J Comp Eff Res. 2015 Mar;4(2):79-88.

FEBRUARY 2015
  1. Chambers JD, Chenoweth M, Cangelosi MJ, Pyo J, Cohen JT, Neumann PJ. Medicare is scrutinizing evidence more tightly for national coverage determinations. Health Aff (Millwood). 2015 Feb 1;34(2):253-260.
  2. Falit BP, Singh SC, Brennan TA. Biosimilar competition in the United States: statutory incentives, payers, and pharmacy benefit managers. Health Aff (Millwood). 2015 Feb 1;34(2):294-301.
  3. Hwang CS, Turner LW, Kruszewski SP, Kolodny A, Alexander GC. Prescription drug abuse: a national survey of primary care physicians. JAMA Intern Med. 2015 Feb 1;175(2):302-304.
  4. Kesselheim AS, Tan YT, Avorn J. The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs. Health Aff (Millwood). 2015 Feb 1;34(2):286-293.
  5. Outterson K, Powers JH, Daniel GW, McClellan MB. Repairing the broken market for antibiotic innovation. Health Aff (Millwood). 2015 Feb 1;34(2):277-285.
  6. Rising JP, Moscovitch B. Characteristics of pivotal trials and FDA review of innovative devices. PLoS One. 2015 Feb 4;10(2):e0117235.
  7. Sarpatwari A, Franklin J, Avorn J, Seeger J, Landon J, Kesselheim A. Are risk evaluation and mitigation strategies associated with less off-label use of medications? The case of immune thrombocytopenia. Clin Pharmacol Ther. 2015 Feb;97(2):186-193.
  8. Seife C. Research misconduct identified by the US Food and Drug Administration: Out of sight, out of mind, out of the peer-reviewed literature. JAMA Intern Med. 2015 Feb 9. [Epub ahead of print]
  9. Wang B, Liu J, Kesselheim AS. Variations in Time of Market Exclusivity Among Top-Selling Prescription Drugs in the United States. JAMA Intern Med. 2015 Feb 9. [Epub ahead of print]
  10. Zetterqvist AV, Merlo J, Mulinari S. Complaints, complainants, and rulings regarding drug promotion in the United kingdom and sweden 2004-2012: a quantitative and qualitative study of pharmaceutical industry self-regulation. PLoS Med. 2015 Feb 17;12(2):e1001785.

JANUARY 2015
  1. Aliferis L. Variation in prices for various medical tests and procedures. JAMA Intern Med. 2015 Jan 1;175(1):11-12.
  2. Chambers JD, Thorat T, Pyo J, Neumann PJ. The lag from FDA approval to published cost-utility evidence. Expert Rev Pharmacoecon Outcomes Res. 2015 Jan 12:1-4.
  3. Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS. Practical, legal, and ethical issues in expanded access to investigational drugs. New Eng J Med. 2015 Jan 15;372(3):279-286.
  4. Drazen JM. Sharing individual patient data from clinical trials. New Eng J Med. 2015 Jan 15;372(3):201-202.
  5. Jacobs DB, Sommers BD. Using drugs to discriminate—adverse selection in the insurance marketplace. New Eng J Med. 2015 Jan 29;372(5):399-402.
  6. Moses H 3rd, Matheson DH, Cairns-Smith S, George BP, Palisch C, Dorsey ER. The anatomy of medical research: US and international comparisons. BMJ. 2015 Jan 28;350:h522. JAMA. 2015 Jan 13;313(2):174-189.
  7. Rajan PV, Kramer DB, Kesselheim AS. Medical device postapproval safety monitoring: where does the United States stand? Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):124-131.
  8. Ryskina KL, Halpern SD, Minyanou NS, Goold SD, Tilburt JC. The Role of Training Environment Care Intensity in US Physician Cost Consciousness. Mayo Clin Proc. 2015 Jan 26. pii: S0025-6196(14)01083-1090.
  9. Sharfstein J. FDA Regulation of Laboratory-Developed Diagnostic Tests: Protect the Public, Advance the Science. JAMA. 2015 Jan 5. [Epub ahead of print]
2014
​​DECEMBER 2014
  1. Bonini S, Eichler HG, Wathion N, Rasi G. Transparency and the European Medicines Agency—sharing of clinical trial data. N Engl J Med. 2014 Dec 25;371(26):2452-2455.
  2. Fischer MA, Choudhry NK, Bykov K, Brill G, Bopp G, Wurst AM, Shrank WH. Pharmacy-based interventions to reduce primary medication nonadherence to cardiovascular medications. Med Care. 2014 Dec;52(12):1050-1054.
  3. Kesselheim AS, Huybrechts KF, Choudhry NK, Fulchino LA, Isaman DL, Kowal MK, Brennan TA. Prescription Drug Insurance Coverage and Patient Health Outcomes: A Systematic Review. Am J Public Health. 2014 Dec 18:e1-e14. [Epub ahead of print]
  4. Nissen SE. Commentary: Confidentiality of interim trial data-The emerging crisis. Clin Trials. 2014 Dec 18. [Epub ahead of print]
  5. Notenboom K, Beers E, van Riet-Nales DA, Egberts TC, Leufkens HG, Jansen PA, Bouvy ML. Practical Problems with Medication Use that Older People Experience: A Qualitative Study. J Am Geriatr Soc. 2014 Dec;62(12):2339-2344.
  6. Riggs KR, Buttorff C, Alexander GC. Impact of Out-of-Pocket Spending Caps on Financial Burden of those with Group Health Insurance. J Gen Intern Med. 2014 Dec 4. [Epub ahead of print]
  7. Zarin DA, Tse T, Sheehan J. The Proposed Rule for U.S. Clinical Trial Registration and Results Submission.N Engl J Med. 2014 Dec 24. [Epub ahead of print]

NOVEMBER 2014
  1. Alpern JD, Stauffer WM, Kesselheim AS. High-cost generic drugs–implications for patients and policymakers. N Engl J Med. 2014 Nov 13;371(20):1859-62.
  2. Baird LG, Banken R, Eichler HG, Kristensen FB, Lee DK, Lim JC, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, Hirsch G. Accelerated access to innovative medicines for patients in need. Clin Pharmacol Ther. 2014 Nov;96(5):559-71.
  3. Becker JE, Ross JS. Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications. Ann Intern Med. 2014 Nov 18;161(10):760.
  4. Gagne JJ, Thompson L, O’Keefe K, Kesselheim AS. Innovative research methods for studying treatments for rare diseases: methodological review. BMJ. 2014 Nov 24;349:g6802.
  5. Lexchin J. Postmarket safety warnings for drugs approved in Canada under the Notice ofCompliance with conditions policy. Br J Clin Pharmacol. 2014 Nov 12. [Epub ahead of print]
  6. Manz C, Ross JS, Grande D. Marketing to physicians in a digital world. N Engl J Med. 2014 Nov 13;371(20):1857-9.
  7. Patel MS, Day S, Small DS, Howell JT 3rd, Lautenbach GL, Nierman EH, Volpp KG. Using Default Options Within the Electronic Health Record to Increase the Prescribing of Generic-Equivalent Medications: A Quasi-experimental Study. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S44-52.
  8. Reynolds IS, Rising JP, Coukell AJ, Paulson KH, Redberg RF. Assessing the Safety and Effectiveness of Devices After US Food and Drug Administration Approval: FDA-Mandated Postapproval Studies. JAMA Intern Med. 2014 Nov 1;174(11):1773-9.
  9. Vermeer NS, Spierings I, Mantel-Teeuwisse AK, Straus SM, Giezen TJ, Leufkens HG, Egberts TC, De Bruin ML. Traceability of biologicals: present challenges in pharmacovigilance. Expert Opin Drug Saf. 2014 Nov 5:1-10. [Epub ahead of print]
  10. Woloshin S, Schwartz LM, Frankel B, Faerber A. US Food and Drug Administration and design of drug approval studies. JAMA. 2014 Nov 26;312(20):2163-5.

OCTOBER 2014
  1. Chambers JD, Thorat T, Pyo J, Chenoweth M, Neumann PJ. Despite high costs, specialty drugs may offer value for money comparable to that of traditional drugs. Health Aff (Millwood). 2014 Oct 1;33(10):1751-60.
  2. Chang CQ, Tingle SR, Filipski KK, Khoury MJ, Lam TK, Schully SD, Ioannidis JP. An overview of recommendations and translational milestones for genomic tests in cancer. Genet Med. 2014 Oct 23. [Epub ahead of print]
  3. Dunn AG, Arachi D, Hudgins J, Tsafnat G, Coiera E, Bourgeois FT. Financial conflicts of interest and conclusions about neuraminidase inhibitors for influenza: an analysis of systematic reviews. Ann Intern Med. 2014 Oct 7;161(7):513-8.
  4. Kesselheim AS, Tan YT, Darrow JJ, Avorn J. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Aff (Millwood). 2014 Oct 1;33(10):1770-8.
  5. Miladinovic B, Kumar A, Mhaskar R, Djulbegovic B. Benchmarks for detecting ‘breakthroughs’ in clinical trials: empirical assessment of the probability of large treatment effects using kernel density estimation. BMJ Open. 2014 Oct 21;4(10):e005249.
  6. Naci H, Alexander GC. Regulators should better leverage effectiveness standards to enhance drug value. Pharmacotherapy. 2014 Oct;34(10):1005-11.
  7. Sarpatwari A, Kesselheim AS, Malin BA, Gagne JJ, Schneeweiss S. Ensuring patient privacy in data sharing for postapproval research. N Engl J Med. 2014 Oct 23;371(17):1644-9.
  8. Starner CI, Alexander GC, Bowen K, Qiu Y, Wickersham PJ, Gleason PP. Specialty drug coupons lower out-of-pocket costs and may improve adherence at the risk of increasing premiums. Health Aff (Millwood). 2014 Oct 1;33(10):1761-9.
  9. Wang B, Canestaro WJ, Choudhry NK.Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in US Food and Drug Administration Drug Labels. JAMA Intern Med. 2014 Oct 13. [Epub ahead of print]
  10. Woodcock J. Paving the critical path of drug development: the CDER perspective. Nat Rev Drug Discov. 2014 Oct 31;13(11):783-4.
  11. Yeh JS, Austad KE, Franklin JM, Chimonas S, Campbell EG, Avorn J, Kesselheim AS. Association of medical students’ reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study. PLoS Med. 2014 Oct 14;11(10):e1001743.

SEPTEMBER 2014
  1. Avorn J. Rethinking the use of physicians as hired expert lecturers. Ann Intern Med. 2014 Sep 2;161(5):363-364.
  2. Brennan TA, Wilson JM. The special case of gene therapy pricing. Nat Biotechnol. 2014 Sep 9;32(9):874-876.
  3. Checchi KD, Huybrechts KF, Avorn J, Kesselheim AS. Electronic medication packaging devices and medication adherence: a systematic review. JAMA. 2014 Sep 24;312(12):1237-1247.
  4. Daubresse M, Alexander GC. The uphill battle facing anti-obesity drugs. Int J Obes (Lond). 2014 Sep 12. [Epub ahead of print]
  5. Evans BJ, Dorschner MO, Burke W, Jarvik GP. Regulatory changes raise troubling questions for genomic testing. Genet Med. 2014 Sep 25. [Epub ahead of print]
  6. Floyd JS, Psaty BM. The potential risks of expedited approval of drugs for acute bacterial infections. JAMA Intern Med. 2014 Sep 1;174(9):1436-1437.
  7. Gagne JJ, Choudhry NK, Kesselheim AS, Polinski JM, Hutchins D, Matlin OS, Brennan TA, Avorn J, Shrank WH. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014 Sep 16;161(6):400-407.
  8. Haffajee R, Parmet WE, Mello MM. What is a public health “emergency”? N Engl J Med. 2014 Sep 11;371(11):986-988.
  9. Joffe S. Evaluating Novel Therapies During the Ebola Epidemic. JAMA. 2014 Sep 11. [Epub ahead of print]
  10. Joffe S, Miller FG. Ethics of cancer clinical trials in low-resource settings. J Clin Oncol. 2014 Sep 2 [Epub ahead of print].
  11. Krumholz HM, Peterson ED. Open access to clinical trials data. JAMA. 2014 Sep 10;312(10):1002-1003.
  12. Redberg RF. Sham controls in medical device trials. N Engl J Med. 2014 Sep 4;371(10):892-893.
  13. Ross JS, Frazee SG, Garavaglia SB, Levin R, Noyshadian H, Jackevicius CA, Stettin G, Krumholz HM. Trends in Use of Ezetimibe After the ENHANCE Trial, 2007 Through 2010. JAMA Intern Med. 2014 Sep 1;174(9):1486-1493.
  14. Vermeer NS, Duijnhoven RG, Straus SM, Mantel-Teeuwisse AK, Arlett PR, Egberts AC, Leufkens HG, De Bruin ML. Risk management plans as tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe. Clin Pharmacol Ther. 2014 Sep 15. [Epub ahead of print]

AUGUST 2014​​
  1. Brodersen J, Schwartz LM, Woloshin S. Overdiagnosis: how cancer screening can turn indolent pathology into illness. APMIS. 2014 Aug;122(8):683-689.
  2. Duke JD, Kesselheim AS. The Food and Drug Administration’s Role in Promoting Consistent Labels for Generic Drugs. JAMA Intern Med. 2014 Aug 1;174(8):1213-1214.
  3. Evans SJ, Leufkens HG. Regulatory decision-making: are we getting it right? Pharmacoepidemiol Drug Saf. 2014 Aug 11 [Epub ahead of print].
  4. Frank C, Himmelstein DU, Woolhandler S, Bor DH, Wolfe SM, Heymann O, Zallman L, Lasser KE. Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals. Health Aff (Millwood). 2014 Aug 1;33(8):1453-1459.
  5. Harrison C. Software patent ruling gives pointers for diagnostics. Nat Rev Drug Discov. 2014 Aug 1;13(8):569.
  6. Hess CN, Roe MT, Gibson CM, J Temple R, Pencina MJ, Zarin DA, Anstrom KJ, Alexander JH, Sherman RE, Fiedorek FT, Mahaffey KW, Lee KL, Chow SC, Armstrong PW, Califf RM. Independent data monitoring committees: preparing a path for the future. Am Heart J. 2014 Aug;168(2):135-141.e1.
  7. Hwang TJ, Bourgeois FT. New Regulatory Paradigms for Innovative Drugs to Treat Pediatric Diseases. JAMA Pediatr. 2014 Aug 11 [Epub ahead of print].
  8. Naci H, Ioannidis JP. How Good Is “Evidence” from Clinical Studies of Drug Effects and Why Might Such Evidence Fail in the Prediction of the Clinical Utility of Drugs? Annu Rev Pharmacol Toxicol. 2014 Aug 21 [Epub ahead of print].
  9. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness–the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371(9):796-797.
  10. Ross JS. It’s Not Just About the Money, Money, Money… JAMA Intern Med. 2014 Aug 25 [Epub ahead of print].
  11. Ross JS. Randomized Clinical Trials and Observational Studies Are More Often Alike Than Unlike. JAMA Intern Med. 2014 Aug 11 [Epub ahead of print].
  12. White C. NICE confirms advanced breast cancer drug is too expensive for NHS. BMJ. 2014 Aug 7;349:g5078.
  13. Wolfe SM. Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products: A Misguided Approach. JAMA Intern Med. 2014 Aug 15 [Epub ahead of print].
  14. Austad KE, Avorn J, Franklin JM, Campbell EG, Kesselheim AS. Association of marketing interactions with medical trainees’ knowledge about evidence-based prescribing: results from a national survey. JAMA Intern Med. 2014 Aug 1;174(8):1283-1290.
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