PORTAL: Program on Regulation, Therapeutics, and Law
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  • About Us
    • What is PORTAL?
    • Core Faculty
    • Research Team
    • Affiliated Faculty & Researchers
    • Expert Roundtable
  • Our Work
    • Publications
    • Policy Action
    • Literature Scan
    • In the Press
    • Media Center
    • Teaching
    • CeBIL
    • Biomarkers >
      • About The Project
      • The PBRC Team
      • Our Collaborators
      • AERO Graph
      • Workshops
      • Biomarkers2018
    • FDA REMS
  • Blog
  • Events
    • #policyethx 2020-2021
    • Events Archive >
      • #policyethx 2019-2020
      • #policyethx 2018-2019
      • #policyethx 2017-2018
      • #policyethx 2016-2017
      • Biosimilar Insulin
      • Older Events
  • Join Us
    • PORTAL Fellowships
    • Program Coordinator
  • Contact
    • Inquiries
    • E-mail List
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EXPERT ROUNDTABLE
May 29, 2019
Harvard Medical School

We brought together experts from academia, industry, the patient advocacy community, and government to share their perspectives about how to lower the cost of insulin for patients and how to regulate insulin so that diabetics can afford their medication.

On June 5th, 2019, PORTAL submitted 
an FDA Docket Submission summarizing policy debates and recommendations from the Expert Roundtable Event. 

The event was co-hosted by PORTAL and the  Harvard-MIT Center for Regulatory Science.

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Background
Insulin was originally isolated and used in clinical care about 100 years ago, with the key scientists famously donating the intellectual property for $1 each so that "anyone would be free to prepare the extract, but no one could secure a profitable monopoly." Since then, there have been a number of important improvements to the insulin product, and currently millions of people around the world depend on various forms of insulin to manage their diabetes. However, in recent years, there have been concerns about the high costs of insulin, which have led to impediments to access and disastrous patient outcomes, and have also strained limited health care resources. In response, many have asked why insulin remains without low-priced "generic" alternatives, which are common in nearly every other class of drugs with such a long history. In this meeting, we discussed a number of the key scientific, regulatory, and clinical issues facing the production, dissemination, and use of inexpensive insulin. 





 
Introductory Remarks
Aaron Kesselheim
Ameet Sarpatwari
Jing Luo

Session I: Clinical Considerations
Laura Marston
Kasia Lipska, Yale University School of Medicine
Teodorina Lessidrenska, T1 International

Session II: Market Considerations
Surya Singh, Singh Health Advisors
Elizabeth Jex, Federal Trade Commission (Remote)

Session III: Scientific/Regulatory Considerations
Cory Wohlbach, Teva Pharmaceuticals
Eva Temkin, Food and Drug Administration

Session IV: Discussion Synthesis
Brainstorming: Next Steps
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Program On Regulation, Therapeutics And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
1620 Tremont Street, Suite 3030
Boston, MA 02120
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