Empirical

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

Interesting empirical studies, policy analyses, and editorials on health law and policy issues from the month of March 2021.

a pill in place of a model globe

Published:

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.

About the authors

  • Ameet Sarpatwari

    Ameet Sarpatwari is an Assistant Professor of Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School.

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  • Beatrice Brown

    Beatrice Brown was a 2019-2020 Petrie-Flom Center Student Fellow.

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  • Neeraj Patel

    Neeraj Patel is Attending Physician, Division of Orthopaedic Surgery and Sports Medicine at Lurie’s Children’s Hospital of Chicago.

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  • Aaron S. Kesselheim

    Aaron S. Kesselheim is Director of Program On Regulation, Therapeutics, And Law (PORTAL). He is Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital.

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