Empirical

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

Interesting empirical studies, policy analyses, and editorials on health law and policy issues from the month of December.

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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 December. The selections feature topics ranging from an analysis of potential approaches for evaluating novel SARS-CoV-2 vaccine candidates after other vaccines have already been authorized; to an examination of social, cultural, and economic aspects of microbial resistance; to a study on clinical evidence supporting FDA clearance of novel therapeutics devices via the de novo pathway. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Darrow JJ, Robertson CT, Kasoff WS. Evidence Supporting the Value of Surgical Procedures: Can We Do Better? Am Surg. 2020 Dec 19:3134820979792. Epub ahead of print.
  2. Joffe S. Evaluating SARS-CoV-2 Vaccines After Emergency Use Authorization or Licensing of Initial Candidate Vaccines. JAMA. 2020 Dec 14. Epub ahead of print.
  3. Johnston JL, Dhruva SS, Ross JS, Rathi VK. Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019. JAMA Intern Med. 2020 Dec 1;180(12):1701-1703.
  4. Mehrotra P, Weber DJ, Sarpatwari A. Preventing medical-device-borne outbreaks: High-level disinfection policy for duodenoscopes. Infect Control Hosp Epidemiol. 2020 Dec 14:1-4. Epub ahead of print.
  5. Minssen T, Outterson K, Rogers Van Katwyk S, Batista PHD, Chandler CIR, Ciabuschi F, Harbarth S, Kesselheim AS, Laxminarayan R, Liddell K, Osterholm MT, Price L, Hoffman SJ. Social, cultural and economic aspects of antimicrobial resistance. Bull World Health Organ. 2020 Dec 1;98(12):823-823A.
  6. Volpp KG, Loewenstein G, Buttenheim AM. Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program. JAMA. 2020 Dec 14. [Epub ahead of print]. (PMID: 33315079).

About the authors

  • Ameet Sarpatwari

    Ameet Sarpatwari is an Assistant Professor of Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School.

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  • Beatrice Brown

    Beatrice Brown was a 2019-2020 Petrie-Flom Center Student Fellow.

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  • Neeraj Patel

    Neeraj Patel is Attending Physician, Division of Orthopaedic Surgery and Sports Medicine at Lurie’s Children’s Hospital of Chicago.

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  • Aaron S. Kesselheim

    Aaron S. Kesselheim is Director of Program On Regulation, Therapeutics, And Law (PORTAL). He is Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital.

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