Roundup: What to Read in 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 May. The selections feature topics ranging from a review of clinical trial setting of drugs used in primary care; to the impact the Orphan Drug Act’s seven-year market exclusivity period; to postmarket studies required by the FDA for new drugs and biologics. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Crossley JR, Tan TP, Smith KH, Ross JS, Merenstein DJ. Review of clinical trial settings of drugs commonly used in primary care and approved between 2005 and 2012. J Gen Intern Med. 2018 May 18. [Epub ahead of print]
  2. Gill J, Obley AJ, Prasad V. Direct-to-Consumer Genetic Testing: The Implications of the US FDA’s First Marketing Authorization for BRCA Mutation Testing. JAMA. 2018 May 18. [Epub ahead of print]
  3. Luo J, Kesselheim AS. “Delayed Generic Market Saturation After Patent Expiration-A Billion-Dollar Problem.” JAMA Intern Med. 2018 May 1;178(5):721-722.
  4. Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow JJ, Kesselheim AS.  Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.”  Health Aff (Millwood). 2018 May;37(5):724-731.
  5. Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS. Evaluating The Impact Of The Orphan Drug Act’s Seven-Year Market Exclusivity Period. Health Aff (Millwood). 2018 May;37(5):732-737.
  6. Sinha MS, Curfman GD, Carrier MA. Antitrust, Market Exclusivity, and Transparency in the Pharmaceutical Industry. JAMA. 2018 May 7. [Epub ahead of print]
  7. Sinha MS, Kesselheim AS. The next forum for unraveling FDA off-label marketing rules: State and federal legislatures. PLoS Med. 2018 May 8;15(5):e1002564. eCollection 2018 May.
  8. Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. BMJ. 2018 May 24;361:k2031.
  9. Woloshin S, Schwartz LM. Overcoming overuse: the way forward is not standing still-an essay by Steven Woloshin and Lisa M Schwartz. BMJ. 2018 May 22;361:k2035.

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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