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 August. The selections feature topics ranging from the characteristics of pre- and post-approval studies for drugs granted accelerated approval by the FDA, to a review of policy options to reduce brand-name drug prices, to characteristics of clinical studies used for FDA approval of high-risk medical device supplements. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Reducing Branded Prescription Drug Prices: A Review of Policy Options. Alexander GC, Ballreich J, Socal MP, Karmarkar T, Trujillo A, Greene J, Sharfstein J, Anderson G. Pharmacotherapy. 2017 Aug 14. [Epub ahead of print]
  2. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study. Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. Ann Intern Med. 2017 Aug 1;167(3):145-151.
  3. 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. Horton DB, Gerhard T, Davidow A, Strom BL. Pharmacoepidemiol Drug Saf. 2017 Aug 31. [Epub ahead of print]
  4. Effect of US Food and Drug Administration’s Cardiovascular Safety Guidance on Diabetes Drug Development. Hwang TJ, Franklin JM, Kesselheim AS. Clin Pharmacol Ther. 2017 Aug;102(2):290-296.
  5. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. Naci H, Smalley KR, Kesselheim AS. JAMA. 2017 Aug 15;318(7):626-636.
  6. Health Insurance Coverage and Health – What the Recent Evidence Tells Us. Sommers BD, Gawande AA, Baicker K. N Eng J Med. 2017 Aug 10;377(6):586-593.
  7. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. Zheng SY, Dhruva SS, Redberg RF. JAMA. 2017 Aug 15;318(7):619-625.

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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