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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Empirical, FDA, Food Safety, Health Law Policy, Human Subjects Research, Pharmaceuticals, PORTAL Round-Up, Professional Regulation, Scientific Evidence

By Ameet Sarpatwari, Aviva Wang, Liam Bendicksen, 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from how Wikipedia pages communicate drug efficacy information, to addressing pharmaceutical industry payments to physicians, to the frequency with which the Food and Drug Administration removes hazardous dietary supplements from the market. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Brown BL, Mitra-Majumdar M, Joyce K, Ross M, Pham C, Darrow JJ, Avorn J, Kesselheim AS. Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review. J Health Polit Policy Law. 2022 Jul 14:10041093. Epub ahead of print.
  2. Cohen PA, Avula B, Katragunta K, Khan I. Recalls, Availability, and Content of Dietary Supplements Following FDA Warning Letters. JAMA. 2022 Jul 26;328(4):393-395.
  3. Darrow JJ, Borisova E. Communication of Drug Efficacy Information via a Popular Online Platform. J Am Board Fam Med. 2022 Jul-Aug;35(4):833-835.
  4. Gyawali B, Booth CM. Defining clinically important overall survival thresholds: lessons from quality of life. Nat Rev Clin Oncol. 2022 Jul 27. Epub ahead of print.
  5. Hwang TJ, Trinh QD, Tibau A, Vokinger KN. Reforms to accelerated approval of new medicines: long overdue. Lancet. 2022 Jul 30;400(10349):357-358.
  6. Lin KJ, Feldman WB, Wang S, Pramod Umarje SP, D’Andrea E, Tesfaye H, Zabotka LE, Liu J, Desai RJ. Gastrointestinal prophylaxis for COVID-19: An illustration of severe bias arising from inappropriate comparators in observational studies. J Clin Epidemiol. 2022 Jul 19:S0895-4356(22)00182-2. Epub ahead of print.
  7. Mitchell A, Sarpatwari A, Bach PB. Industry Payments to Physicians are Kickbacks. How Should Stakeholders Respond? J Health Polit Policy Law. 2022 Jul 14:10041205. Epub ahead of print.
  8. Rand LZ, Kesselheim AS. Payments for research participation: Don’t tax the Guinea pig. Clin Trials. 2022 Jul 2:17407745221105896. Epub ahead of print.
  9. Sarpatwari A, Kesselheim AS, Cook-Deegan R. Bayh-Dole at 40: Accomplishments, Challenges, and Possible Reforms. J Health Polit Policy Law. 2022 Jul 14:10041247. 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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