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

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 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 December. The selections feature topics ranging from potential Medicare savings on inhaler prescriptions through use of negotiated prices and a defined formulary, to evaluation of the REMS for extended-release/long-acting opioids, to the costs of medication non-adherence in adults with atherosclerotic cardiovascular disease in the US. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Cohen PA, Bass S. Injecting Safety into Supplements – Modernizing the Dietary Supplement Law. N Engl J Med. 2019 Dec 19;381(25):2387-2389.
  2. Feldman WB, Avorn J, Kesselheim AS. Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary. JAMA Intern Med. 2019 Dec 2. [Epub ahead of print]
  3. Hey SP. Why High Drug Pricing Is A Problem for Research Ethics. J Bioeth Inq. 2019 Dec 19. [Epub ahead of print]
  4. Heyward J, Olson L, Sharfstein JM, Stuart EA, Lurie P, Alexander GC. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: A Review. JAMA Intern Med. 2019 Dec 30. [Epub ahead of print]
  5. Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS. FDA and EMA Biosimilar Approvals. J Gen Intern Med. 2019 Dec 2. [Epub ahead of print]
  6. Khera R, Valero-Elizondo J, Das SR, Virani SS, Kash BA, de Lemos JA, Krumholz HM, Nasir K. Cost-Related Medication Nonadherence in Adults With Atherosclerotic Cardiovascular Disease in the United States, 2013 to 2017. Circulation, 140 (25), 2067-2075. 2019 Dec 17.
  7. Prasad V, Booth CM. Multiplicity in Oncology Randomised Controlled Trials: A Threat to Medical Evidence? Lancet Oncol, 20 (12), 1638-1640. Dec 2019.
  8. Vargas V, Leopold C, Castillo-Riquelme M, Darrow JJ. Expanding Coverage of Oncology Drugs in an Aging, Upper-Middle-Income Country: Analyses of Public and Private Expenditures in Chile. J Glob Oncol, 5, 1-17. Dec 2019.

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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