Stacks of books against a burgundy wall

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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, 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 November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Annapureddy AR, Henien S, Wang Y, Minges KE, Ross JS, Spatz ES, Desai NR, Peterson PN, Masoudi FA, Curtis JP. Association Between Industry Payments to Physicians and Device Selection in ICD Implantation. 2020 Nov 3;324(17):1755-1764.
  2. Darrow JJ, Sharma M, Shroff M, Wagner AK. Efficacy and costs of spinal muscular atrophy drugs. Sci Transl Med. 2020 Nov 11;12(569):eaay9648.
  3. DeMartino PC, Miljkovic MD, Prasad V. Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018. JAMA Intern Med. 2020 Nov 9:e205921. Epub ahead of print.
  4. Druedahl LC, Almarsdóttir AB, Kälvemark Sporrong S, De Bruin ML, Hoogland H, Minssen T, van de Weert M, Kesselheim AS, Sarpatwari A. A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways. Nat Biotechnol. 2020 Nov;38(11):1253-1256.
  5. Elliott MH, Skydel JJ, Dhruva SS, Ross JS, Wallach JD. Characteristics and Reporting of Number Needed to Treat, Number Needed to Harm, and Absolute Risk Reduction in Controlled Clinical Trials, 2001-2019. JAMA Intern Med. 2020 Nov 23:e204799. Epub ahead of print.
  6. Feldman WB, Gagne JJ, Kesselheim AS. Trends in Medicare Part D Inhaler Spending, 2012-2018. Ann Am Thorac Soc. 2020 Nov 18. Epub ahead of print.
  7. Kesselheim AS, Darrow JJ, Kulldorff M, Brown BL, Mitra-Majumdar M, Lee CC, Moneer O, Avorn J. An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19. Health Aff (Millwood). 2020 Nov 19:101377hlthaff202001620. Epub ahead of print.
  8. Lee CC, Kesselheim AS, Avorn J. Variations in Generic Combination Opioid Use Across State Medicaid Programs. J Gen Intern Med. 2020 Nov 2. Epub ahead of print.
  9. Lynch HF, Bateman-House A, Joffe S. Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research. Ann Intern Med. 2020 Nov 3:M20-6703. doi: 10.7326/M20-6703. Epub ahead of print.
  10. McCormick N, Wallace ZS, Yokose C, Jorge A, Sacks CA, Hsu J, Choi HK. Prolonged Increases in Public-Payer Spending and Prices After Unapproved Drug Initiative Approval of Colchicine. JAMA Intern Med. 2020 Nov 30. Epub ahead of print.
  11. Sarpatwari A, He M, Tessema FA, Gagne JJ, Kesselheim AS. Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program. Drug Saf. 2020 Nov 18. Epub ahead of print.
  12. Warren RC, Forrow L, Hodge DA Sr, Truog RD. Trustworthiness before Trust – Covid-19 Vaccine Trials and the Black Community. N Engl J Med. 2020 Nov 26;383(22):e121. doi: 10.1056/NEJMp2030033. Epub 2020 Oct 16.

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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