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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron 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 June. The selections feature topics ranging from a discussion of potential pathways to enable government patent use before nonpatent exclusivities expire, to an examination of medical oncologists who receive more than $100,000 annually from pharmaceutical companies, to an analysis of the launch prices of new drugs from 2008-2021. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Wright K, Meyers DE, Chisamore TM, et al. Industry Relationships With Medical Oncologists: Who Are the High-Payment Physicians? JCO Oncol Pract. 2022 Jun 13;OP2100756. Epub ahead of print.
  2. Woloshin S, Kesselheim AS. What to Know About the Alzheimer Drug Aducanumab (Aduhelm). JAMA Intern Med. 2022 Jun 6. Epub ahead of print.
  3. Wolitz RE, Kesselheim AS, Darrow JJ. Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities. Am J Public Health. 2022 Jun 16:e1-e5. Epub ahead of print.
  4. Sinha MS, Dineen Gillespie KK. Realigning Incentives for Novel Pain Therapeutics. 2022 Jun 21. Epub ahead of print.
  5. Rome BN, Egilman AC, Kesselheim AS. Trends in Prescription Drug Launch Prices, 2008-2021. 2022 Jun 7;327(21):2145-2147.
  6. Raymakers AJN, Kesselheim AS. Promoting Confidence in Cost-Effectiveness Analyses. 2022 Jun 22;377:o1452.
  7. Rathi VK, Ross JS, Redberg RF, Dhruva SS. Medical Device User Fee Reauthorization – Back to Basics or Looking Ahead? N Engl J Med. 2022 Jun 8. Epub ahead of print.
  8. Mousavi I, Olivier T, Prasad V. Cost Per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022. JAMA Netw Open. 2022 Jun 1;5(6):e2216058.
  9. Lythgoe MP, Desai A, et al. Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019. JAMA Netw Open. 2022 Jun 1;5(6):e2216183.
  10. Lalani HS, Kesselheim AS, Rome BN. Potential Medicare Part D Savings on Generic Drugs From the Mark Cuban Cost Plus Drug Company. Ann Intern Med. 2022 Jun 21. Epub ahead of print.
  11. Hwang TJ, Isaac-Wilkins S, Trinh QD. Trends in Launch Prices and Price Increases for New Medicines for Urological Cancers. J Urol. 2022 Jun 27;101097JU0000000000002825. Epub ahead of print.
  12. Hwang TJ, Kesselheim AS, Tibau A, Lee CC, Vokinger KN. Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia. JCO Oncol Pract. 2022 Jun 22;OP2100909. Epub ahead of print.
  13. Faridi KF, Dayoub EJ, Ross JS, Dhruva SS, Ahmad T, Desai NR. Medicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure. J Am Coll Cardiol. 2022 Jun 28;79(25):2516-2525.
  14. Cherla A, Mossialos E, Salcher-Konrad M, Kesselheim AS, Naci H. Post-Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004-2014. Clin Pharmacol Ther. 2022 Jun 5. 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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