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Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Beatrice Brown, FDA, Generic Drugs, Health Law Policy, International, Medical devices, Medicare/Medicaid, Patient Care, Pharmaceuticals, PORTAL Round-Up

By Ameet Sarpatwari, Beatrice Brown, Alexander Egilman, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of June. The selections feature topics ranging from an analysis of the characteristics of clinical studies supporting supplemental indications approved between 2017 and 2019, to an evaluation of the effect of California’s prescription drug coupon ban on generic drug use, to a comparison of how various international regulatory bodies approach postmarket safety communication. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bhasale AL, Sarpatwari A, De Bruin ML, Lexchin J, Lopert R, Bahri P, Mintzes BJ. Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States. Clin Pharmacol Ther. 2021 Jun;109(6):1424-1442.
  2. Brito JP, Ross JS, El Kawkgi OM, Maraka S, Deng Y, Shah ND, Lipska KJ. Levothyroxine Use in the United States, 2008-2018. JAMA Intern Med. 2021 Jun 21. Epub ahead of print.
  3. Dhodapkar M, Zhang AD, Puthumana J, Downing NS, Shah ND, Ross JS. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Netw Open. 2021 Jun 1;4(6):e2113224.
  4. Egilman A, Wallach JD, Puthumana J, Zhang AD, Schwartz JL, Ross JS. Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration. J Gen Intern Med. 2021 Jun 15. Epub ahead of print.
  5. Hernandez I, Rowe D, Gellad WF, Good CB. Trends in the Use of Conventional and New Pharmaceuticals for Hemophilia Treatments Among Medicaid Enrollees, 2005-2020. JAMA Netw Open. 2021 Jun 1;4(6):e2112044.
  6. Johnston JL, Dhruva SS, Ross JS, Rathi VK. Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020.JAMA Intern Med. 2021 Jun 21. Epub ahead of print.
  7. Ramachandran R, Dhodapkar M, Ross JS, Schwartz JL. Future of covid-19 vaccine pricing: lessons from influenza. BMJ. 2021 Jun 22;373:n1467.
  8. Rome BN, Lee CC, Gagne JJ, Kesselheim AS. Factors Associated With Generic Drug Uptake in the United States, 2012 to 2017. Value Health. 2021 Jun;24(6):804-811. Epub 2021 Apr 22.
  9. Rome BN, Gagne JJ, Kesselheim AS. Association of California’s Prescription Drug Coupon Ban With Generic Drug Use. JAMA. 2021 Jun 15;325(23):2399-2402.
  10. Rome BN, Kesselheim AS. Will Ending the Medicaid Drug Rebate Cap Lower Drug Prices? JAMA Intern Med. 2021 Jun 28. Epub ahead of print.
  11. Thomson S, Witzke N, Gyawali B, Delos Santos S, Udayakumar S, Cardone C, Cheung MC, Chan KKW. Assessing the benefit of cancer drugs approved by the European Medicines Agency using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale over time. Eur J Cancer. 2021 Jun;150:203-210. Epub 2021 Apr 29.

Ameet Sarpatwari

Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

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