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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

FDA REMS


About our study:

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We are a group of investigators at Harvard Medical School and Brigham and Women’s Hospital conducting research on Risk Evaluation and Mitigation Strategy (REMS) programs, which the Food and Drug Administration (FDA) requires the manufacturers of certain medications to implement. Our project team is seeking to better understand the benefits and burdens of REMS programs on patient care. Our work is being funded by the FDA and does not involve any pharmaceutical companies.
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Participation opportunities:
If you meet the criteria below and are interested in participating in the study,
​please email 
asarpatwari@bwh.harvard.edu for more information.

1. Xyrem or Xywav (sodium oxybate)

Have you started taking Xyrem or Xywav (sodium oxybate) in the past 3 years? 
​If yes, we want to talk to you!
 
We would like to extend an invitation to individuals age 18 or above who started taking Xyrem or Xywav (sodium oxybate)—a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on their experiences. Participants will receive a $50 Amazon gift card as a token of appreciation.
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2. Letairis (ambrisentan) or
​Tracleer (bosentan)


Have you started taking Letairis (ambrisentan) or Tracleer (bosentan) in the past 3 years? ​If yes, we want to talk to you!

We would like to extend an invitation to female patients between the ages of 18 and 45 who started taking Letairis (ambrisentan) or Tracleer (bosentan)—a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on their experiences. Participants will receive a $50 Amazon gift card as a token of appreciation.

3. Lemtrada (alemtuzumab)

​Have you started taking Lemtrada (alemtuzumab) in the past 3 years? ​If yes, we want to talk to you!

We would like to extend an invitation to individuals age 18 or above who started taking Lemtrada (alemtuzumab) —a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on their experiences. Participants will receive a $50 Amazon gift card as a token of appreciation.

​4. Clozaril (clozapine)

​Have you started taking Clozaril (clozapine) in the past 3 years? ​If yes, we want to talk to you!

We would like to extend an invitation to individuals age 18 or above who started taking or care for someone who started taking Clozaril (clozapine) —a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on their experiences. Participants will receive a $50 Amazon gift card as a token of appreciation.

​5. Palynziq ​(pegvaliase-pqpz)

Have you started taking Palynziq (pegvaliase-pqpz) in the past 3 years? ​If yes, we want to talk to you!

We would like to extend an invitation to individuals age 18 or above who started taking or care for someone who started taking Palynziq (pegvaliase-pqpz) —a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on their experiences. Participants will receive a $50 Amazon gift card as a token of appreciation.

​6. Accutane ​(isotretinoin)

Have you started taking Accutane (isotretinoin) in the past 3 years? ​If yes, we want to talk to you!

We would like to extend an invitation to female patients between the ages of 18 and 45 who started taking Accutane (isotretinoin) —a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on their experiences. Participants will receive a $50 Amazon gift card as a token of appreciation.

7. Revlimid (lenalidomide) or
​Pomalyst (pomalidomide) or
Thalomid ​(thalidomide)

Have you started taking Revlimid (lenalidomide) or Pomalyst (pomalidomide) or Thalomid (thalidomide) in the past 3 years? ​If yes, we want to talk to you!

We would like to extend an invitation to female patients between the ages of 18 and 45 who started taking Revlimid (lenalidomide) or Pomalyst (pomalidomide) or Thalomid (thalidomide) —a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on their experiences. Participants will receive a $50 Amazon gift card as a token of appreciation.

Study Team

  • ​Ameet Sarpatwari, PhD, JD 
  • Aaron S. Kesselheim MD, JD, MPH
  • Will Feldman, MD, DPhil
  • Aviva Wang, MS
  • ​Su Been Lee, BA
  • Heidi Zakoul, BA
  • Alex Cervone, BA
  • Chinenye Iroajanma, BA

Contact Us

Principal Investigator
Ameet Sarpatwari, PhD, JD 
​
Email: asarpatwari@bwh.harvard.edu
Phone: ​(617) 278-0930

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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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