Magazines on wooden table on bright background.

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

By Ameet Sarpatwari, 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 April. The selections feature topics ranging from an analysis of government and industry investments for recently approved drugs, to a discussion of court decisions on mifepristone, and an examination of the added therapeutic benefit associated with the top-selling brand-name drugs in Medicare.

A full posting of abstracts/summaries of these articles may be found on our website.

  1. Galkina Cleary E, Jackson MJ, Zhou EW, Ledley FD. Comparison of Research Spending on New Drug Approvals by the National Institutes of Health vs the Pharmaceutical Industry, 2010-2019. JAMA Health Forum. 2023 Apr 7;4(4):e230511. (PMID: 37115539).
  2. Aaron DG, Brown TR, Sinha MS. Court Intrusion Into Science and Medicine-the Mifepristone Decisions. JAMA. 2023 Apr 26. [Epub ahead of print]. (PMID: 37099527).
  3. Avorn J. Surrogate Measures of Drug Efficacy-A Finger Pointing at the Moon. JAMA Netw Open. 2023 Apr 3;6(4):e238835. (PMID: 37115553).
  4. Cliff ERS, Kesselheim AS, Rome BN, Feldman WB. Trends in Medicare Spending on Oral Drugs for Chronic Lymphocytic Leukemia From 2014 to 2020. JAMA Netw Open. 2023 Apr 3;6(4):e237467. (PMID: 37027159).
  5. Egilman AC, Rome BN, Kesselheim AS. Added Therapeutic Benefit of Top-Selling Brand-name Drugs in Medicare. JAMA. 2023 Apr 18;329(15):1283-1289. (PMID: 37071095).
  6. Essa M, Ross JS, Dhruva SS, Desai NR, Yeh RW, Faridi KF. Trends in Spending and Claims for P2Y12 Inhibitors by Medicare and Medicaid From 2015 to 2020. J Am Heart Assoc. 2023 Apr 18;12(8):e028869. [Epub 2023 Apr 12]. (PMID: 37042289).
  7. Hamburg M, Sharfstein J. Judicial Interference with Mifepristone. Science. 2023 Apr 21;380(6642):223. [Epub 2023 Apr 13]. (PMID: 37053463).
  8. McPhail M, Zhang H, Bhimani Z, Bubela T. Lessons from Canada’s Notice of Compliance with Conditions Policy for the Life-Cycle Regulation of Drugs. J Law Biosci. 2023 Apr 12;10(1):lsad008. (PMID: 37064046).
  9. Olivier T, Haslam A, Prasad V. Is Financial Toxicity Captured in Quality of Life Assessments in Oncology Randomized Clinical Trials? J Cancer Policy. 2023 Apr 17;36:100423. [Epub ahead of print]. (PMID: 37075841).
  10. Rome BN, Kesselheim AS. Biosimilar Competition for Humira is Here: Signs of Hope Despite Early Hiccups. Arthritis Rheumatol. 2023 Apr 7. [Epub ahead of print]. (PMID: 37026489).

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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