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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Charlie Lee, Contributors, FDA, Frazer Tessema, Health Law Policy, Human Subjects Research, Pharmaceuticals, PORTAL Round-Up

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of April. The selections feature topics ranging from increases in Internet searches for hydroxychloroquine following promotional remarks by the President, to an evaluation of health gains from orphan drugs, to an assessment of clinical trials supporting new FDA drug approvals. A full posting of abstracts/summaries of these articles can be found on our website.

  1. Bhasale A, Mintzes B, Sarpatwari A. Communicating Emerging Risks of SGLT2 Inhibitors-Timeliness and Transparency of Medicine Regulators. BMJ. 2020 Apr 29;369:m1107.
  2. Chambers JD, Silver MC, Berklein FC, Cohen JT, Neumann PJ. Orphan Drugs Offer Larger Health Gains but Less Favorable Cost-Effectiveness than Non-Orphan Drugs. J Gen Intern Med. 2020 Apr 13. Epub ahead of print.
  3. Chen EY, Haslam A, Prasad V. FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019. JAMA Intern Med. 2020 Apr 27. Epub ahead of print.
  4. Dal-Re R, Kesselheim AS, Bourgeois FT. Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials. JAMA. 2020 Apr 23. Epub ahead of print.
  5. Hey SP, Gerlach CV, Dunlap G, Prasad V, Kesselheim AS. The Evidence Landscape in Precision Medicine. Sci Transl Med. 2020 Apr 22;12(540). Pii. Review.
  6. Hey SP, Gyawali B, D’Andrea E, Kanagaraj M, Franklin JM, Kesselheim AS. A Systematic Review and Meta-Analysis of Bevacizumab in First-line Metastatic Breast Cancer: Lessons for Research and Regulatory Enterprises. J Natl Cancer Inst. 2020 Apr 1;112(4):335-342.
  7. Liu M, Caputi TL, Dredze M, Kesselheim AS, Ayers JW. Internet Searches for Unproven COVID-19 Therapies in the United States. JAMA Intern Med. 2020 Apr 29. Epub ahead of print.
  8. Rome BN, Avorn J. Drug Evaluation During the Covid-19 Pandemic. N Engl J Med. 2020 Apr 14. Epub ahead of print.
  9. Vreman RA, Naci H, Goettsch WG, Mantel-Teeuwisse AK, Schneeweiss SG, Leufkens HGM, Kesselheim AS. Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe. Clin Pharmacol Ther. 2020 Apr 1. 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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