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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Beatrice Brown, FDA, Generic Drugs, Health Law Policy, International, Medicare/Medicaid, Opioid Crisis, Pharmaceuticals, PORTAL Round-Up, Public Health, Publications, Vaccines

By Ameet Sarpatwari, Beatrice Brown, 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 May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Darrow JJ. Few new drugs deserve expedited regulatory treatment. J Manag Care Spec Pharm. 2021 May;27(5):685-688.
  2. Gonsalves G, Yamey G. The covid-19 vaccine patent waiver: a crucial step towards a “people’s vaccine”. BMJ. 2021 May 17;373:n1249.
  3. Gunter SJ, Kesselheim AS, Rome BN. Market Exclusivity and Changes in Competition and Prices Associated With the US Food and Drug Administration Unapproved Drug Initiative. JAMA Intern Med. 2021 May 17:e211989. Epub ahead of print.
  4. Gyawali B, Darrow JJ, Kesselheim AS. Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling. JAMA Intern Med. 2021 May 17. Epub ahead of print.
  5. Kannappan S, Darrow JJ, Kesselheim AS, Beall RF. The timing of 30-month stay expirations and generic entry: A cohort study of first generics, 2013-2020. Clin Transl Sci. 2021 May 13. Epub ahead of print.
  6. Long AS, Zhang AD, Meyer CE, Egilman AC, Ross JS, Wallach JD. Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review. JAMA Netw Open. 2021 May 3;4(5):e215731. PMID: 33956134.
  7. Messinger JC, Ikeda DJ, Sarpatwari A. Civil commitment for opioid misuse: do short-term benefits outweigh long-term harms? J Med Ethics. 2021 May 27:medethics-2020-107160. Epub ahead of print.
  8. Miller JE, Mello MM, Wallach JD, Gudbranson EM, Bohlig B, Ross JS, Gross CP, Bach PB. Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs. JAMA Netw Open. 2021 May 3;4(5):e217075.
  9. Moneer O, Miller JE, Shah ND, Ross JS. Direct-to-consumer personal genomic tests need better regulation. Nat Med. 2021 May 20. Epub ahead of print.
  10. Patel AN, Kesselheim AS, Rome BN. Frequency Of Generic Drug Price Spikes And Impact On Medicaid Spending. Health Aff (Millwood). 2021 May;40(5):779-785.
  11. Pregelj L, Hine DC, Kesselheim AS, Darrow JJ. Assessing the Impact of FDA Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed. Clin Pharmacol Ther. 2021 May 28. Epub ahead of print.
  12. Rome BN, Feldman WB, Desai RJ, Kesselheim AS. Correlation Between Changes in Brand-Name Drug Prices and Patient Out-of-Pocket Costs. JAMA Netw Open. 2021 May 3;4(5):e218816.
  13. San-Juan-Rodriguez A, Gellad WF, Shrank WH, Good CB, Hernandez I. A decade of increases in Medicare Part B pharmaceutical spending: what are the drivers? J Manag Care Spec Pharm. 2021 May;27(5):565-573.
  14. Sarpatwari A, Tessema FA, Zakarian M, Najafzadeh MN, Kesselheim AS. Diabetes Drugs: List Price Increases Were Not Always Reflected In Net Price; Impact Of Brand Competition Unclear. Health Aff (Millwood). 2021 May;40(5):772-778.
  15. Volpp KG, Cannuscio CC. Incentives for Immunity – Strategies for Increasing Covid-19 Vaccine Uptake. N Engl J Med. 2021 May 26. 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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