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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Charlie Lee, Contributors, FDA, Frazer Tessema, Health Law Policy, Human Subjects Research, Off-Label Use, Pharmaceuticals, PORTAL Round-Up

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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.

Below are the abstracts/summaries for papers identified from the month of March. The selections feature topics ranging from the utilization and cost of naloxone for patients at high risk of opioid overdose, to off-label and compassionate drug use in the COVID-19 pandemic, to public-sector financial support and sponsorship for gene therapy trials in the U.S. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Barenie RE, Gagne JJ, Kesselheim AS, et al. Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014-2018. Drug Saf. 2020 Mar 16. [Epub ahead of print].
  2. Cipriani A, Ioannidis JPA, Rothwell PM, et al. Generating comparative evidence on new drugs and devices after approval. Lancet (London, England). 2020 Mar 21;395(10228):998-1010.
  3. Fralick M, Kesselheim AS. Using real-world safety data in regulatory approval decisions: Sotagliflozin and  the risk of diabetic ketoacidosis. Pharmacoepidemiol Drug Saf. 2020 Mar 18. [Epub ahead of print].
  4. Gostin LO, Wood AJ, Cuff PA. Regulating Medicines in a Globalized World With Increased Recognition and Reliance Among Regulators: A National Academies Report. JAMA. 2020 Mar 5. [Epub ahead of print].
  5. Kalil AC. Treating COVID-19-Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics. JAMA. 2020 Mar 24. [Epub ahead of print].
  6. Kassir Z, Sarpatwari A, Kocak B, Kuza CC, Gellad WF. Sponsorship and Funding for Gene Therapy Trials in the United States. JAMA. 2020 Mar 3;323(9):890-891.
  7. Lin KJ, Dvorin E, Kesselheim AS. Prescribing systemic steroids for acute respiratory tract infections in United States outpatient settings: A nationwide population-based cohort study. PLoS Med. 2020 Mar 31;17(3):e1003058.
  8. Liu P, Dhruva SS, Shah ND, Ross JS. Medicare beneficiaries’ out-of-pocket costs for commonly used generic drugs, 2009-2017. Am J Manag Care. 2020 Mar;26(3):112-117.
  9. Luo J, Kesselheim AS, Sarpatwari A. Insulin access and affordability in the USA: anticipating the first interchangeable insulin product. Lancet Diabetes Endocrinol. 2020 Mar 20. [Epub ahead of print].
  10. Naci H, Salcher-Konrad M, Kesselheim AS, et al. Generating comparative evidence on new drugs and devices before approval. Lancet (London, England). 2020 Mar 21;395(10228):986-997.
  11. Ong C, Ly VK, Redberg RF. Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices. JAMA Intern Med. 2020 Mar 30.
  12. Parmet WE, Sinha MS. Covid-19 – The Law and Limits of Quarantine. N Engl J Med. 2020 Mar 18. [Epub ahead of print].
  13. Rome BN, Kesselheim AS. Federal Spending on Off-Patent Drugs That Lack Generic Competition. J Gen Intern Med. 2020 Mar 6. [Epub ahead of print].
  14. Yazdany J, Kim AH. Use of Hydroxychloroquine and Chloroquine During the COVID-19 Pandemic: What Every Clinician Should Know. Ann Intern Med. 2020 Mar 31; [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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