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

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 September. The selections feature topics ranging from an analysis of the regulatory outcomes of cancer drugs that received accelerated approval and had negative post-approval trials, to an evaluation of how federal public funding contributed to the development of Pregabalin (Lyrica), to a systematic literature review of the criticisms against the use of the quality-adjusted life-year (QALY) in health technology assessments. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Barenie R, Darrow J, Avorn J, Kesselheim A. Discovery and Development of Pregabalin (Lyrica): The Role of Public Funding. Neurology. 2021 Sep 7. Epub ahead of print. PMID: 34493615.
  2. Bujosa A, Moltó C, Hwang TJ, Tapia JC, Vokinger KN, Templeton AJ, Gich I, Barnadas A, Amir E, Tibau A. Associations With Definitive Outcomes and Clinical Benefit of Cancer Drugs at the Time of Marketing Approval and in the Postmarketing Period. J Natl Compr Canc Netw. 2021 Sep 24:1-9. Epub ahead of print. PMID: 34560672.
  3. Gill J, Sarpatwari A, Prasad V. The implications of Industry-Funded Disease Awareness Campaigns in the Rare Disease Setting. Mayo Clin Proc. 2021 Sep;96(9):2305-2308. PMID: 34481596.
  4. Gyawali B, Rome BN, Kesselheim AS. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study. BMJ. 2021 Sep 8;374:n1959. PMID: 34497044.
  5. Rand LZ, Kesselheim AS. International reference pricing for prescription drugs: a landscape analysis. J Manag Care Spec Pharm. 2021 Sep;27(9):1309-1313. PMID: 34464208.
  6. Rand LZ, Kesselheim AS. Controversy Over Using Quality-Adjusted Life-Years In Cost-Effectiveness Analyses: A Systematic Literature Review. Health Aff (Millwood). 2021 Sep;40(9):1402-1410. PMID: 34495724.
  7. Rome BN, Avorn J, Kesselheim AS. Characteristics of US Patients and Prescribers Using Hydroxychloroquine During the COVID-19 Pandemic. J Gen Intern Med. 2021 Sep 24. Epub ahead of print. PMID: 34561824.
  8. Vokinger KN, Kesselheim AS. Value-based pricing of drugs with multiple indications or in combinations – lessons from Europe. Nat Rev Clin Oncol. 2021 Sep 23. Epub ahead of print. PMID: 34556845.
  9. Walsh BS, Bloomfield D, Kesselheim AS. A Court Decision on “Skinny Labeling”: Another Challenge for Less Expensive Drugs. JAMA. 2021 Sep 13. Epub ahead of print. PMID: 34515733.

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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