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

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 analysis of the approval and marketing of biosimilars with a skinny label and their associated Medicare savings, to a discussion of the Philips Respironics recall and the need for reforms to U.S. medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Demkowicz BJ, Tu SS, Kesselheim AS, Carrier MA, Feldman WB. Patenting Strategies on Inhaler Delivery Devices. Chest. 2023 Feb 25;S0012-3692(23)00301-X. Epub ahead of print.
  2. DiStefano MJ, Markell JM, Doherty CC, Alexander GC, Anderson GF. Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising. JAMA. 2023 Feb 7;329(5):386-392.
  3. Dubin JM, Fantus RJ, Bennett NE, Brannigan RE, Thirumavalavan N, Halpern JA. Guideline-Discordant Care Among Direct-to-Consumer Testosterone Therapy Platforms. JAMA Intern Med. 2022 Dec 1;182(12):1321-1323.
  4. Johnston JL, Ross JS, Ramachandran R. US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021. JAMA Intern Med. 2023 Feb 13:e226444. Epub ahead of print.
  5. Naci H, Forrest R, Zhai M, Stofesky AR, Kesselheim AS. Characteristics of Prior Authorization Policies for New Drugs in Medicare Part D. JAMA Health Forum. 2023 Feb 3;4(2):e225610.
  6. Pham C, Le K, Draves M, Seoane-Vazquez E. Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020. JAMA Intern Med. 2023 Feb 13:e226787. Epub ahead of print.
  7. Rome BN, Gunter SJ, Kesselheim AS. Market dynamics of authorized generics in Medicaid from 2014 to 2020. Health Serv Res. 2023 Feb 23. Epub ahead of print.
  8. Tu SS, Nagar S, Kesselheim AS. Recent Patent Reform Bills and Their Implications for Prescription Drugs. JAMA. 2023 Feb 14;329(6):459-460.
  9. Tu SS, Sarpatwari A. A “Method of Use” to Prevent Generic and Biosimilar Market Entry. N Engl J Med. 2023 Feb 9;388(6):483-485.
  10. Van de Wiele VL, Kesselheim AS, Beran D, Darrow JJ. Insulin products and patents in the USA in 2004, 2014, and 2020: a cross-sectional study. Lancet Diabetes Endocrinol. 2023 Feb;11(2):73-75.

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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