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

Ameet Sarpatwari Health Law 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 December. The selections feature topics ranging from the benefits, limitations, and value of abuse-deterrent opioids; to PDUFA VI; to Medicare formulary restrictions for prescription opioids. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Curfman GD, Beletsky L, Sarpatwari A. Benefits, Limitations, and Value of Abuse-Deterrent Opioids. JAMA Intern Med. 2017 Dec 11. [Epub ahead of print]
  2. Darrow JJ, Beall RF, Kesselheim AS. Will inter partes review speed US generic drug entry? Nat Biotechnol. 2017 Dec 8;35(12):1139-1141.
  3. Darrow JJ, Avorn J, Kesselheim AS. Speed, Safety, and Industry Funding—From PDUFA I to PDUFA VI. N Engl J Med. 2017 Dec 7;377(23):2278-2286.
  4. Dave CV, Hartzema A, Kesselheim AS. Prices of Generic Drugs Associated with Numbers of Manufacturers. N Engl J Med. 2017 Dec 28;377(36):2597-2598.
  5. Hwang TJ, Darrow JJ, Kesselheim AS. The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016. JAMA. 2017 Dec 5;318(21):2137-2138.
  6. Miller JE, Wilenzick M, Ritcey N, Ross JS, Mello MM. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies. BMJ Open. 2017 Dec 5;7(12). [Epub ahead of print]
  7. Pinnow E, Amr S, Bentzen SM, Brajovic S, Hungerford L, St George DM, Dal Pan G. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014. Clin Pharmacol Ther. 2017 Dec 20. [Epub ahead of print]
  8. Samuels EA, Ross JS, Dhruva SS. Medicare Formulary Coverage Restrictions for Prescription Opioids, 2006 to 2015. Ann Intern Med. 2017 Dec 19;167(12):895-896.

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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