A male pharmacist is examining a drug from a pharmacy inventory.

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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Empirical, FDA, Generic Drugs, Insurance, Intellectual Property, International, Medicare/Medicaid, Pharmaceuticals, PORTAL Round-Up

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, 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 April. The selections feature topics ranging from a discussion of manufacturer’s restricted delivery of 340B drugs to contract pharmacies and ensuing litigation, to an analysis mapping the European patent landscape for medical uses of known products, to an evaluation of the clinical benefit of novel drugs approved in the U.S. from 2018-2019. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Aboy M, Liddell K, Jordan M, Crespo C, Liddicoat J. European patent protection for medical uses of known products and drug repurposing. Nat Biotechnol. 2022 Apr;40(4):465-471.
  2. Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults. JAMA Intern Med. 2022 Apr 1;182(4):418-425.
  3. Feldman D, Avorn J, Kesselheim AS. Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration. JAMA Netw Open. 2022 Apr 1;5(4):e227958.
  4. Knox RP, Kesselheim AS, Sarpatwari A. Risks to the 340B Drug Pricing Program Related to Manufacturer Restrictions on Drug Availability. JAMA. 2022 Apr 15. Epub ahead of print.
  5. Lalani HS, Kesselheim AS, Rome BN. Direct-to-Consumer Generic Drugs: A Maverick Approach or Another Exposure of Market Failures? Ann Intern Med. 2022 Apr 19. Epub ahead of print.
  6. Polak TB, Cucchi DGJ, Darrow JJ, Versteegh MM. Incremental benefits of novel pharmaceuticals in the UK: a cross-sectional analysis of NICE technology appraisals from 2010 to 2020. BMJ Open. 2022 Apr 8;12(4):e058279.
  7. Rome BN, Sarpatwari A, Kesselheim AS. State Laws and Generic Substitution in the Year After New Generic Competition. Value Health. 2022 Apr 26:S1098-3015(22)00154-1. Epub ahead of print.
  8. Samuel JN, Booth CM, Eisenhauer E, Brundage M, Berry SR, Gyawali B. Association of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class. JAMA Oncol. 2022 Apr 28:e220864. Epub ahead of print.
  9. Vokinger KN, Hwang TJ, Glaus CEG, Kesselheim AS. Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019. JAMA Netw Open. 2022 Apr 1;5(4):e226479.
  10. Whitehouse P, Gandy S, Saini V, George DR, Larson EB, Alexander GC, Avorn J, Brownlee S, Camp C, Chertkow H, Fugh-Berman A, Howard R, Kesselheim A, Langa KM, Perry G, Richard E, Schneider L. Making the Case for Accelerated Withdrawal of Aducanumab. J Alzheimers Dis. 2022 Apr 5. Epub ahead of print.
  11. Xiao R, Ross JS, Gross CP, Dusetzina SB, McWilliams JM, Sethi RKV, Rathi VK. Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance. JAMA Intern Med. 2022 Apr 18. 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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