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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, Empirical, FDA, Health Law Policy, Medical devices, Pharmaceuticals, PORTAL Round-Up, Vaccines

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, 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 pharmaceutical policy.

Below are the citations for papers identified from the month of March. The selections feature topics ranging from a commentary on the evidence base for the Alzheimer’s drug aducanumab (which is currently under FDA review), to a comparative study of drug pricing in the U.S. and France, to a study of the demographic characteristics of participants in vaccine trials leading to FDA approval. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Alexander GC, Emerson S, Kesselheim AS. Evaluation of Aducanumab for Alzheimer Disease: Scientific Evidence and Regulatory Review Involving Efficacy, Safety, and Futility. 2021 Mar 30. Epub ahead of print.
  2. Barenie RE, Kesselheim AS, Tsacogianis T, Fischer MA. Associations Between Copays, Coverage Limits for Opioid Use Disorder Medications, and Prescribing in Medicaid, 2018. Med Care. 2021 Mar 1;59(3):266-272.
  3. Del Paggio JC, Berry JS, Hopman WM, Eisenhauer EA, Prasad V, Gyawali B, Booth CM. Evolution of the Randomized Clinical Trial in the Era of Precision Oncology. JAMA Oncol. 2021 Mar 25. Epub ahead of print.
  4. Gyawali B, Kesselheim AS. FDA approval standards for anticancer agents – lessons from two recent approvals in breast cancer. Nat Rev Clin Oncol. 2021 Mar 25. doi: 10.1038/s41571-021-00504-1. Epub ahead of print.
  5. Kesselheim AS, Hwang TJ, Avorn J. Paying for Prescription Drugs in the New Administration. JAMA. 2021 Mar 2;325(9):819-820.
  6. Raimond VC, Feldman WB, Rome BN, Kesselheim AS. Why France Spends Less Than the United States on Drugs: A Comparative Study of Drug Pricing and Pricing Regulation. Milbank Q. 2021 Mar;99(1):240-272.
  7. Rathi VK, Johnston JL, Ross JS, Dhruva SS. Medicare’s New Device-Coverage Pathway – Breakthrough or Breakdown? N Engl J Med. 2021 Mar 25;384(12):e43.
  8. Rome BN, Kesselheim AS. Federal Spending on Off-Patent Drugs That Lack Generic Competition. J Gen Intern Med. 2021 Mar;36(3):821-823.
  9. Sharfstein JM, Goodman JL, Borio L. The US Regulatory System and COVID-19 Vaccines: The Importance of a Strong and Capable FDA. 2021 Mar 23;325(12):1153-1154.
  10. Walsh BS, Kesselheim AS. CAAP Rule and Prescription Drug Prices. Am J Manag Care. 2021 Mar 18;27(8).
  11. Zhang AD, Puthumana J, Egilman AC, Schwartz JL, Ross JS. Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010-2020. J Gen Intern Med. 2021 Mar 3:1–3. Epub ahead of print.

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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