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

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 February. The selections feature topics ranging from new drug formulations and their respective generic entry dates, to the FDA’s REMS for transmucosal immediate-release fentanyl products, to the price changes of existing TNF inhibitors after market entry of competitors. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RF, Kesselheim AS, Sarpatwari A. New Drug Formulations and Their Respective Generic Entry Dates. J Manag Care Spec Pharm. 2019 Feb;25(2):218-224.
  2. Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS. Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases. Health Aff (Millwood). 2019 Feb;38(2):313-319.
  3. Rollman JE, Heyward J, Olson L, Lurie P, Sharfstein J, Alexander GC. Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products. JAMA. 2019 Feb 19;321(7):676-685.
  4. San-Juan-Rodriguez A, Prokopovich MV, Shrank WH, Good CB, Hernandez I. Assessment of Price Changes of Existing Tumor Necrosis Factor Inhibitors After the Market Entry of Competitors. JAMA Intern Med. 2019 Feb 18. [Epub ahead of print]
  5. Sarpatwari A, Curfman G. Mitigating Health Risks of Prescription Drugs: Lessons From FDA Oversight of Opioid Products. JAMA. 2019 Feb 19;321(7):651-653.
  6. Thomas S, Caplan A. The Orphan Drug Act Revisited. JAMA. 2019 Feb 15. [Epub ahead of print]
Ameet Sarpatwari

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.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.