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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, FDA, Health Law Policy, Medical devices, Medical Safety, Medicare/Medicaid, Opioid Crisis, Pharmaceuticals, PORTAL Round-Up, Professional Regulation

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 March. The selections feature topics ranging from a discussion of patient assistance programs and the Anti-Kickback Statute, to an analysis of the effects of state opioid prescribing laws on the use of opioids and other pain treatments, to an evaluation of the association between regulatory drug safety advisories and changes in drug use. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bendicksen L, Kesselheim AS. Anticipated efficiencies, real costs: Medicaid managed care organizations and the pharmacy benefit. J Manag Care Spec Pharm. 2022 Mar;28(3):354-361.
  2. Dhruva SS, Darrow JJ, Kesselheim AS, Redberg RF. Strategies to manage drugs and devices approved based on limited evidence: results of a modified Delphi panel. Clin Pharmacol Ther. 2022 Mar 16. Epub ahead of print.
  3. Hidano D, Dhruva SS, Redberg RF. US Food and Drug Administration-mandated postmarketing studies for high-risk cardiovascular devices approved 2015-2019. JAMA Intern Med. 2022 Mar 14:e220184. Epub ahead of print.
  4. McGinty EE, Bicket MC, Seewald NJ, Stuart EA, Alexander GC, Barry CL, McCourt AD, Rutkow L. Effects of state opioid prescribing laws on use of opioid and other pain treatments among commercially insured U.S. adults. Ann Intern Med. 2022 Mar 15. Epub ahead of print.
  5. Morrow RL, Mintzes B, Souverein PC, De Bruin ML, Roughead EE, Lexchin J, Kemp-Casey A, Puil L, Sketris I, Mangin D, Hallgreen CE, Pearson SA, Lopert R, Bero L, Ofori-Asenso R, Gnjidic D, Sarpatwari A, Perry LT, Dormuth CR. Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis. BMJ Qual Saf. 2022 Mar;31(3):179-190. Epub ahead of print.
  6. Sinha MS, Kesselheim AS, Robertson CT. Patient assistance programs and the Anti-Kickback Statute: charting a pathway forward. 2022 Mar 10. Epub ahead of print.
  7. Vokinger KN, Hwang TJ, Carl DL, Laube Y, Ludwig WD, Naci H, Kesselheim AS. Price changes and within-class competition of cancer drugs in the USA and Europe: a comparative analysis. Lancet Oncol. 2022 Apr;23(4):514-520. Epub ahead of print.
  8. Woloshin S, Dewitt B, Krishnamurti T, Fischhoff B. Assessing how consumers interpret and act on results from at-home COVID-19 self-test kits: a randomized clinical trial. JAMA Intern Med. 2022 Mar 1;182(3):332-341.

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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