Nov 13, 2018

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

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By Ameet Sarpatwari 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 October. The selections feature topics ranging from out-of-pocket spending on orphan drugs, to a systematic review of the FDA’s exception from informed consent pathway, to the association between progression-free survival and patients’ quality of life in cancer clinical trials. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Chua KP, Conti RM. Out-of-pocket Spending on Orphan Drug Prescriptions Among Commercially Insured Adults in 2014. J Gen Intern Med. 2018 Oct 15. [Epub ahead of print]
  2. Cutler DM. Extending the User Fee Approach to Pharmaceuticals. JAMA. 2018 Oct 16;320(15):1525-1526.
  3. Feldman WB, Hey SP, Kesselheim AS. A Systematic Review Of The Food And Drug Administration’s ‘Exception From Informed Consent’ Pathway. Health Aff (Millwood). 2018 Oct;37(10):1605-1614.
  4. Hwang TJ, Gyawali B. Association between progression-free survival and patients’ quality of life in cancer clinical trials. Int J Cancer. 2018 Oct 29. [Epub ahead of print]
  5. Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM. Internal Medicine Physicians’ Financial Relationships with Industry: An Updated National Estimate. J Gen Intern Med. 2018 Oct 5. [Epub ahead of print]


Photo by wp paarz/Flickr

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Ameet Sarpatwari · Health Law Policy

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