One pill on mint green background.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, 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 May. The selections feature topics ranging from a discussion of how the US Patent and Trademark Office could more closely scrutinize applications for drug patents whose siblings have been discontinued in other jurisdictions, to an evaluation of FDA advisory committee referrals for new drugs approved from 2010-2021, to an analysis of the patents and regulatory exclusivities on inhalers approved from 1986-2020. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bloomfield D, Lu Z, Kesselheim AS. Improving the quality of US drug patents through international awareness. BMJ. 2022 May 17;377:e068172.
  2. Cohen PA, Avorn J, Kesselheim AS. Institutionalizing Misinformation – The Dietary Supplement Listing Act of 2022. N Engl J Med. 2022 May 18. Epub ahead of print.
  3. Daval CJR, Sarpatwari A, Kesselheim AS. Unwanted Advice? Frequency, Characteristics, And Outcomes Of Negative Advisory Committee Votes For FDA-Approved Drugs. Health Aff (Millwood). 2022 May;41(5):713-721.
  4. Feldman WB, Bloomfield D, Beall RF, Kesselheim AS. Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986-2020. Health Aff (Millwood). 2022 May 17:101377hlthaff202101874. Epub ahead of print.
  5. Hemphill CS, Sampat BN. Fixing The FDA’s Orange Book. Health Aff (Millwood). 2022 May 17:101377hlthaff202200369. Epub ahead of print.
  6. Mitra-Majumdar M, Gunter SJ, Kesselheim AS, Brown BL, Joyce KW, Ross M, Pham C, Avorn J, Darrow JJ. Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020. JAMA Netw Open. 2022 May 2;5(5):e2212454.
  7. Moneer O, Daly G, Skydel JJ, Nyhan K, Lurie P, Ross JS, Wallach JD. Agreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study. BMJ. 2022 May 10;377:e069400.
  8. Naci H, Kyriopoulos I, Feldman WB, Hwang TJ, Kesselheim AS, Chandra A. Coverage of New Drugs in Medicare Part D. Milbank Q. 2022 May 3. Epub ahead of print.
  9. Suda KJ, Kim KC, Hernandez I, Gellad WF, Rothenberger S, Campbell A, Malliart L, Tadrous M. The global impact of COVID-19 on drug purchases: A cross-sectional time series analysis. J Am Pharm Assoc (2003). 2022 May-Jun;62(3):766-774.e6. 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.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.