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, Informed Consent, International, Pharmaceuticals, PORTAL Round-Up, Vaccines

By Ameet Sarpatwari, Beatrice 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 April. The selections feature topics ranging from the pre-market development times for innovative vaccines, to an assessment of FDA postmarketing requirements and commitments from 2009 to 2018, to an analysis of implementation challenges and potential effects of U.S. adoption of international reference pricing for prescription drugs. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RF, Kesselheim AS, Hollis A. Pre-market development times for innovative vaccines – to what extent are the COVID-19 vaccines outliers? Clin Infect Dis. 2021 Apr 29:ciab389. Epub ahead of print.
  2. Darrow JJ, Dhruva SS, Redberg RF. Changing FDA Approval Standards: Ethical Implications for Patient Consent. J Gen Intern Med. 2021 Apr 8:1–3. Epub ahead of print.
  3. Franklin JM, Platt R, Dreyer NA, London AJ, Simon GE, Watanabe JH, Horberg M, Hernandez A, Califf RM. When can nonrandomized studies support valid inference regarding effectiveness or safety of new medical treatments? Clin Pharmacol Ther. 2021 Apr 7. Epub ahead of print.
  4. Gowda V, Beall RF, Kesselheim AS, Sarpatwari A. Identifying potential prescription drug product hopping. Nat Biotechnol. 2021 Apr;39(4):414-417.
  5. Moneer O, Lee CC, Avorn J, Kesselheim AS. Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020. JAMA Netw Open. 2021 Apr 1;4(4):e218530.
  6. Rand LZ, Kesselheim AS. International Reference Pricing for Prescription Drugs in the United States: Administrative Limitations and Collateral Effects. Value Health. 2021 Apr;24(4):473-476.
  7. Sarpatwari A, Mitra-Majumdar M, Bykov K, Avorn J, Woloshin S, Toyserkani GA, LaCivita C, Manzo C, Zhou EH, Pinnow E, Dal Pan GJ, Gagne JJ, Huybrechts KF, Feldman WB, Chin K, Kesselheim AS. A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs. Drug Saf. 2021 Apr 27. Epub ahead of print.
  8. Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018. Clin Trials. 2021 Apr 16:17407745211005044. Epub ahead of print.
  9. Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Netw Open. 2021 Apr 1;4(4):e217063.

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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