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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 September. The selections feature topics ranging from the contributions of academia and industry to lung cancer survival gains, to the savings from the EpiPen authorized generic, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Allen H, Sommers BD. Medicaid Expansion and Health: Assessing the Evidence After 5 Years. JAMA. 2019 September 6. [Epub ahead of print]
  2. Brighthaupt SC, Stone EM, Rutkow L, McGinty EE. Effect of pill mill laws on opioid overdose deaths in Ohio & Tennessee: A mixed-methods case study. Prev Med. 2019;126:105736.
  3. Gyawali B, Bouche G, Pantziarka P, Kesselheim AS, Sarpatwari A. Lung Cancer Survival Gains: Contributions of Academia and Industry. J Law Med Ethics. 2019;47(3):465-467.
  4. Hernandez I, Shrank WH, Good CB, Gellad WF. Savings from the EpiPen Authorized Generic: a Retrospective Analysis of Medicaid Data. J Gen Intern Med. 2019 September;34(9):1682-1684.
  5. Hey SP, Feldman WB, Jung EH, D’Andrea E, Kesselheim AS. Surrogate Endpoints and Drug Regulation: What is Needed to Clarify the Evidence. J Law Med Ethics. 2019;47(3):381-387.
  6. Kesselheim AS, Sinha MS, Rausch P, et al. Patients’ Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey. J Law Med Ethics. 2019;47(3):430-441.
  7. Tau N, Shochat T, Gafter-Gvili A, Tibau A, Amir E, Shepshelovich D. Association Between Data Sources and US Food and Drug Administration Drug Safety Communications. JAMA Intern Med. 2019 September 3. [Epub ahead of print]
  8. Zhang AD, Schwartz JL, Ross JS. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015. Milbank Q. 2019;97(3):796-819.
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.

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