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

By Ameet SarpatwariBeatrice 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 health law and policy issues.

Below are the citations for papers identified from the month of October. The selections feature topics ranging from a commentary calling for reconsideration of the FDA’s risk evaluation and mitigation strategy (REMS) program for mifepristone, to an analysis of clinical development times for biosimilars seeking FDA approval, to an editorial describing the challenges of using the Defense Production Act to address drug shortages. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Barankay I, Reese PP, Putt ME, Russell LB, Loewenstein G, Pagnotti D, Yan J, Zhu J, McGilloway R, Brennan T, Finnerty D, Hoffer K, Chadha S, Volpp KG. Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019429.
  2. Barenie RE, Avorn J, Tessema F, Kesselheim AS. Public funding for transformative drugs: the case of sofosbuvir. Drug Discov Today. 2020 Oct 1:S1359-6446(20)30381-0. Epub ahead of print.
  3. Brown BL, Wood SF, Sarpatwari A. Ensuring Safe Access to Mifepristone During the Pandemic and Beyond. Ann Intern Med. 2020 Oct 21:M20-6671. Epub ahead of print.
  4. Feinberg BA, Gajra A, Zettler ME, Phillips TD, Phillips EG Jr, Kish JK. Use of Real-World Evidence to Support FDA Approval of Oncology Drugs. Value Health. 2020 Oct;23(10):1358-1365. Epub 2020 Sep 14.
  5. Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study. BMJ. 2020 Oct 7;371:m3434.
  6. Johnston JL, Dhruva SS, Ross JS, Rathi VK. Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019. JAMA Intern Med. 2020 Oct 12:e203214. Epub ahead of print.
  7. Lee CC, Kesselheim AS, Sarpatwari A. Clinical Development Times for Biosimilars in the United States. Mayo Clin Proc. 2020 Oct;95(10):2152-2154.
  8. Naci H, Kesselheim AS, Røttingen JA, Salanti G, Vandvik PO, Cipriani A. Producing and using timely comparative evidence on drugs: lessons from clinical trials for covid-19. BMJ. 2020 Oct 16;371:m3869.
  9. Pundi K, Perino AC, Harrington RA, Krumholz HM, Turakhia MP. Characteristics and Strength of Evidence of COVID-19 Studies Registered on JAMA Intern Med. 2020 Oct 1;180(10):1398-1400.
  10. Raunig BL, Kesselheim AS, Darrow JJ. Drug Shortages and the Defense Production Act. Am J Public Health. 2020 Oct;110(10):1504-1505.
  11. Rome BN, Kesselheim AS. Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis. Clin Infect Dis. 2020 Oct 23;71(7):1671-1675.
  12. Sarpatwari A, Avorn J, Kesselheim AS. Accounting for US public funding in drug development: how can we better balance access, affordability, and innovation? BMJ. 2020 Oct 8;371:m3841.

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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