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

By Ameet Sarpatwari, Michael S. Sinha, 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 November. The selections feature topics ranging from the use of health care databases to support supplemental indications of approved medications, to the impact of the black triangle label on prescribing in the United Kingdom, to the role of emergency legal authority in addressing the opioid crisis. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Alpern JD, Zhang L, Stauffer WM, Kesselheim AS. Trends in Pricing and Generic Competition Within the Oral Antibiotic Drug Market in the United States. Clin Infect Dis. 2017 Nov 13;65(11):1848-1852.
  2. Fralick M, Kesselheim AS, Avorn J, Schneeweiss S. Use of Health Care Databases to Support Supplemental Indications of Approved Medications. JAMA Intern Med. 2017 Nov 20.
  3. Hakim A, Gupta R, Ross JS. High Costs of FDA Approval for Formerly Unapproved Marketed Drugs. JAMA. 2017 Nov 13. [Epub ahead of print]
  4. Horton DB, Gerhard T, Davidow A, Strom BL. Impact of the black triangle label on prescribing of new drugs in the United Kingdom: lessons for the United States at a time of deregulation. Pharmacoepidemiol Drug Saf. 2017 Nov;26(11):1307-1313.
  5. London AJ. Learning Health Systems, Clinical Equipoise, and the Ethics of Response Adaptive Randomisation. BMJ. 2017 Nov 24. [Epub ahead of print]
  6. Kim J, Ross JS, Kapczynski A. Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS. JAMA. 2017 Nov 8. [Epub ahead of print]
  7. Rutkow L, Vernick JS. Emergency Legal Authority and the Opioid Crisis. N Engl J Med. 2017 Nov 15. [Epub ahead of print]
  8. Sarpatwari A, Gluck AR, Curfman GD. The Supreme Court Ruling in Sandoz v Amgen: A Victory for Fellow-on Biologics. JAMA Intern Med. 2017 Nov 13. [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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