Asthma inhalers on table against blurred background.

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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Medicare/Medicaid, Pharmaceuticals, PORTAL Round-Up

By Ameet Sarpatwari,  Liam Bendicksen, 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from a study of inhaler manufacturers’ revenues after the expiration of primary patents, to an analysis of the clinical value of drugs that companies heavily market to consumers on television, to an exploration of how the public sector and academic institutions have contributed to gene therapy innovation. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Clemans-Cope L, Epstein M, Banthin J, Kesselheim AS, Hwang TJ. Estimates of Medicaid and Non-Medicaid Net Prices of Top-Selling Brand-name Drugs Incorporating Best Price Rebates, 2015 to 2019. JAMA Health Forum. 2023 Jan 6;4(1):e225012.
  2. Egilman AC, Kesselheim AS, Rome BN. Estimated Medicare Part B Savings From Inflationary Rebates. JAMA. 2023 Jan 3;329(1):89-92.
  3. Everhart AO, Sen S, Stern AD, Zhu Y, Karaca-Mandic P. Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance. JAMA. 2023 Jan 10;329(2):144-156.
  4. Feldman WB, Tu SS, Alhiary R, Kesselheim AS, Wouters OJ. Manufacturer Revenue on Inhalers After Expiration of Primary Patents, 2000-2021. JAMA. 2023 Jan 3;329(1):87-89.
  5. Jenei K, Meyers D, Gyawali B. Assessment of Price and Clinical Benefit of Cancer Drugs in Canada, 2011-2020. JAMA Netw Open. 2023 Jan 3;6(1):e2253438.
  6. Kadakia KT, Dhruva SS, Caraballo C, Ross JS, Krumholz HM. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls. JAMA. 2023 Jan 10;329(2):136-143.
  7. Patel NG, Hwang TJ, Woloshin S, Kesselheim AS. Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021. JAMA Netw Open. 2023 Jan 3;6(1):e2250991.
  8. Roberts TJ, Kesselheim AS, Avorn J. Variation in Use of Lung Cancer Targeted Therapies Across State Medicaid Programs, 2020-2021. JAMA Netw Open. 2023 Jan 3;6(1):e2252562.
  9. Rome BN, Nagar S, Egilman AC, Wang J, Feldman WB, Kesselheim AS. Simulated Medicare Drug Price Negotiation Under the Inflation Reduction Act of 2022. JAMA Health Forum. 2023 Jan 6;4(1):e225218.
  10. Tu SS, Nagar S, Kesselheim AS. Recent Patent Reform Bills and Their Implications for Prescription Drugs. JAMA. 2023 Jan 13. Epub ahead of print.
  11. Vokinger KN, Avorn J, Kesselheim AS. Sources of Innovation in Gene Therapies – Approaches to Achieving Affordable Prices. N Engl J Med. 2023 Jan 26;388(4):292-295. 
  12. Wang J, Lee CC, Kesselheim AS, Rome BN. Estimated Medicaid Spending on Original and Citrate-Free Adalimumab From 2014 Through 2021. JAMA Intern Med. 2023 Jan 30. 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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