LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Beatrice Brown, Empirical, FDA, Health Law Policy, Judicial Opinions, Opioid Crisis, Pharmaceuticals, PORTAL Round-Up, Publications

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, 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.

Below are the citations for papers identified from the month of February. The selections feature topics ranging from an evaluation of utilization and spending on different formulations of opioid use disorder medication buprenorphine, to an analysis of the impact of the 2012 circuit court ruling in United States v. Caronia on subsequent government enforcement of off-label marketing restrictions, to an assessment of key features of the relationship between public and private actors in the context of biomedical innovation during the COVID-19 pandemic. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Barenie RE, Kesselheim AS. Buprenorphine for opioid use disorder: The role of public funding in its development. Drug Alcohol Depend. 2021 Feb 1;219:108491. Epub ahead of print.
  2. Barenie RE, Sinha MS, Kesselheim AS. Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018. Value Health. 2021 Feb;24(2):182-187. Epub ahead of print.
  3. Cherla A, Naci H, Kesselheim AS, Gyawali B, Mossialos E. Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval. JAMA Intern Med. 2021 Feb 22. Epub ahead of print.
  4. Darrow JJ, Light DW. Beyond The High Prices Of Prescription Drugs: A Framework To Assess Costs, Resource Allocation, And Public Funding. Health Aff (Millwood). 2021 Feb;40(2):281-288.
  5. Liu S, Mello MM, Kesselheim AS. Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases. J Health Polit Policy Law. 2021 Feb 22:8893571. Epub ahead of print.
  6. Meyers DE, Jenei K, Chisamore TM, Gyawali B. Evaluation of the Clinical Benefit of Cancer Drugs Submitted for Reimbursement Recommendation Decisions in Canada. JAMA Intern Med. 2021 Feb 22. Epub ahead of print.
  7. Sampat BN, Shadlen KC. The COVID-19 Innovation System. Health Aff (Millwood). 2021 Mar;40(3):400-409. Epub ahead of print.

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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