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 January. The selections feature topics ranging from the savings possible from greater generic substitution in Medicare; to proposed federal right to try legislation; to the characteristics of interim publications and final publications from RCTs. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Egilman AC, Wallach JD, Ross JS, Dhruva SS. Medicare Spending and Potential Savings on Brand-Name Drugs with Available Generic Substitutes Excluded by 2 Large Pharmacy Benefit Managers, 2012 Through 2015. JAMA Intern Med. 2018 Jan 16. [Epub ahead of print]
  2. Fuse Brown EC, Sarpatwari A. Removing ERISA’s Impediment to State Health Reform. N Eng J Med. 2018 Jan 4;378(1):5-7.
  3. Joffe S, Lynch HF. Federal Right-to-Try Legislation—Threatening the FDA’s Public Health Mission. N Eng J Med. 2018 Jan 10. [Epub ahead of print]
  4. Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS. Social Media Impact of the Food and Drug Administration’s Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis. JMIR Public Health Surveill. 2018 Jan 5;4(1).
  5. Sommers BD, Kesselheim AS. Massachusetts’ Proposed Medicaid Reforms – Cheaper Drugs and Better Coverage? N Engl J Med. 2018 Jan 11;378(2):109-111.
  6. Woloshin S, Schwartz LM, Bagley PJ, Blunt HB, White B. Characteristics of Interim Publications of Randomized Clinical Trials and Comparison with Final Publications. JAMA. 2018 Jan 23;319(4):404-406.

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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