LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Beatrice Brown, FDA, Health Law Policy, Medicare/Medicaid, Pharmaceuticals, PORTAL Round-Up

By Ameet Sarpatwari, Beatrice Brown, 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 February. The selections feature topics ranging from an analysis of how the Bayh-Dole Act can be updated to promote innovation and affordable access to drugs developed using federal funds, to an examination of the upcoming reauthorization of the Prescription Drug User Fee Act and its implications for FDA regulation and policies, to a systematic review and meta-analysis of preapproval clinical testing of biosimilars used in the treatment of cancer. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bakker E, Hendrikse NM, Ehmann F, van der Meer DS, Llinares Garcia J, Vetter T, Starokozhko V, Mol PGM. Biomarker qualification at the European Medicines Agency: a review of biomarker qualification procedures from 2008 to 2020. Clin Pharmacol Ther. 2022 Feb 9. Epub ahead of print. PMID: 35137949.
  2. Bloomfield D, D’Andrea E, Nagar S, Kesselheim A. Characteristics of Clinical Trials Evaluating Biosimilars in the Treatment of Cancer: A Systematic Review and Meta-analysis. JAMA Oncol. 2022 Feb 3. Epub ahead of print. PMID: 35113135.
  3. Cook-Deegan R, Kesselheim AS, Sarpatwari A. Updating the Bayh-Dole Act: March-in Rights and Transparency. JAMA. 2022 Feb 24. Epub ahead of print. PMID: 35201276.
  4. Dhruva SS, Darrow JJ, Kesselheim AS, Redberg RF. Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. J Gen Intern Med. 2022 Feb 9. Epub ahead of print. PMID: 35138547.
  5. Duarte-García A, Crowson CS, McCoy RG, Herrin J, Lam V, Putman MS, Ross JS, Matteson EL, Shah ND. Association Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology. Mayo Clin Proc. 2022 Feb;97(2):250-260. PMID: 35120693.
  6. Engelberg AB, Avorn J, Kesselheim AS. A New Way to Contain Unaffordable Medication Costs – Exercising the Government’s Existing Rights. N Engl J Med. 2022 Feb 9. doi: 10.1056/NEJMp2117102. Epub ahead of print. PMID: 35139270.
  7. Feldman WB, Avorn J, Kesselheim AS. Switching to Over-the-Counter Availability of Rescue Inhalers for Asthma. JAMA. 2022 Feb 21. Epub ahead of print. PMID: 35188561.
  8. Hwang TJ, Vokinger KN. New EU regulation on health technology assessment of cancer medicines. Lancet Oncol. 2022 Feb;23(2):e58. PMID: 35114127.
  9. Hwang TJ, Feng J, Maini L, Kesselheim AS. Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018. J Gen Intern Med. 2022 Feb 22. Epub ahead of print. PMID: 35194743.
  10. Mitchell AP, Trivedi NU, Bach PB. The Prescription Drug User Fee Act: Much More Than User Fees. Med Care. 2022 Feb 10. Epub ahead of print. PMID: 35149663.
  11. Moneer O, Brown BL, Avorn J, Darrow JJ, Mitra-Majumdar M, Joyce KW, Ross M, Pham C, Kesselheim AS. New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence. Drug Saf. 2022 Feb 19. Epub ahead of print. PMID: 35182362.
  12. Moshkovits I, Shepshelovich D. Emergency Use Authorizations of COVID-19-Related Medical Products. JAMA Intern Med. 2022 Feb 1;182(2):228-229. PMID: 34928303.
  13. Radomski TR, Decker A, Khodyakov D, Thorpe CT, Hanlon JT, Roberts MS, Fine MJ, Gellad WF. Development of a Metric to Detect and Decrease Low-Value Prescribing in Older Adults. JAMA Netw Open. 2022 Feb 1;5(2):e2148599. PMID: 35166780.
  14. Van de Wiele VL, Hammer M, Parikh R, Feldman WB, Sarpatwari A, Kesselheim AS. Competition law and pricing among biologic drugs: the case of VEGF therapy for retinal diseases. J Law Biosci. 2022 Feb 22;9(1):lsac001. PMID: 35211322.
  15. Walsh BS, Darrow JJ, Kesselheim AS. Recent Orange and Purple Book legislation suggests a need to bridge drug and biologic patent regimes. Nat Biotechnol. 2022 Feb;40(2):167-169. PMID: 35169305.

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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