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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 November. The selections feature topics ranging from the impact of state laws restricting opioid duration, to Medicare spending on drugs and biologics not recommended by the international health technology assessment agencies, to a randomized study of providing evidence context to mitigate physician misinterpretation from off-label drug promotion. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Dave C V, Patorno E, Franklin JM, et al. Impact of State Laws Restricting Opioid Duration on Characteristics of New Opioid Prescriptions. J Gen Intern Med. 2019 Nov;34(11):2339-2341.
  2. Egilman AC, Wallach JD, Dhruva SS, Gonsalves GS, Ross JS. Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies. J Gen Intern Med. 2019 Nov;34(11):2319-2321.
  3. Hwang TJ, Sinha MS, Dave C V, Kesselheim AS. Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications. Mayo Clin Proc. 2019 Nov 1. pii: S0025-6196(19)30481-1. [Epub ahead of print]
  4. Kesselheim AS, Sinha MS, Campbell EG, et al. Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem. Drug Saf. 2019 Nov;42(11):1287-1295.
  5. Mehta SJ, Volpp KG, Troxel AB, et al. Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence (Way 2 Text): a Randomized Clinical Trial. J Gen Intern Med. 2019 Nov;34(11):2397-2404.
  6. Rathi VK, Ross JS. Modernizing the FDA’s 510(k) Pathway. N Engl J Med. 2019 Nov 14;381(20):1891-1893.
  7. Schwartz LM, Woloshin S, Lu Z, et al. Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion. Circ Cardiovasc Qual Outcomes. 2019 Nov;12(11):e006073.
  8. Solotke MT, Ross JS, Shah ND, Karaca-Mandic P, Dhruva SS. Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings. J Manag Care Spec Pharm. 2019 Nov;25(11):1201-1217.

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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