Map of United States made up of pills.

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 January. The selections feature topics ranging from an analysis of recent regulatory and legal developments in drug-pricing transparency, to an argument for the extent to which political actors should have influence over the FDA, to a descriptive analysis of state-level drug product selection laws. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Banerjee R, Prasad V. Pragmatic trials with prespecified subgroups: what oncologists can learn from COVID-19. Nat Rev Clin Oncol. 2021 Jan;18(1):7-8.
  2. Feldman WB, Rome BN, Avorn J, Kesselheim AS. The Future of Drug-Pricing Transparency. N Engl J Med. 2021 Jan 13. Epub ahead of print.
  3. Fernandez Lynch H, Joffe S, McCoy MS. The limits of acceptable political influence over the FDA. Nat Med. 2021 Jan 18. Epub ahead of print.
  4. Rai AK, Price WN 2nd. An administrative fix for manufacturing process patent thickets. Nat Biotechnol. 2021 Jan;39(1):20-22.
  5. Rome BN, Gagne JJ, Avorn J, Kesselheim AS. Non-warfarin oral anticoagulant copayments and adherence in atrial fibrillation: A population-based cohort study. Am Heart J. 2021 Jan 14;233:109-121. Epub ahead of print.
  6. Sacks CA, Van de Wiele VL, Fulchino LA, Patel L, Kesselheim AS, Sarpatwari A. Assessment of Variation in State Regulation of Generic Drug and Interchangeable Biologic Substitutions. JAMA Intern Med. 2021 Jan 1;181(1):16-22.
  7. Sahragardjoonegani B, Beall RF, Kesselheim AS, Hollis A. Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997. J Pharm Policy Pract. 2021 Jan 4;14(1):3.
  8. San-Juan-Rodriguez A, Piro VM, Good CB, Gellad WF, Hernandez I. Trends in list prices, net prices, and discounts of self-administered injectable tumor necrosis factor inhibitors. J Manag Care Spec Pharm. 2021 Jan;27(1):112-117. 

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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