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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, Contributors, Empirical, FDA, Health Law Policy, Human Subjects Research, Off-Label Use, Patient Care, Pharmaceuticals, PORTAL Round-Up, Scientific Evidence

By Ameet Sarpatwari, Beatrice 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 August. The selections feature topics ranging from a commentary on the need for rigorous scientific evaluation of COVID-19 vaccine candidates in the face of political and economic pressures, to an evaluation of patients’ and pharmacists’ experiences with pill appearance changes, to an examination of the extent and cost of potentially inappropriate prescription drug prescriptions for older adults. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Avorn J, Kesselheim A. Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency. JAMA. 2020 Aug 31. Epub ahead of print.
  2. Barenie RE, Kesselheim AS, Gagne JJ, Lu Z, Campbell EG, Dutcher SK, Jiang W, Sarpatwari A. Preferences for and experiences with pill appearance changes: national surveys of patients and pharmacists. Am J Manag Care. 2020 Aug;26(8):340-347.
  3. Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clin Trials. 2020 Aug 24:1740774520949157. Epub ahead of print.
  4. Daniels AM, Studdert DM. Hepatitis C Treatment in Prisons – Incarcerated People’s Uncertain Right to Direct-Acting Antiviral Therapy. N Engl J Med. 2020 Aug 13;383(7):611-613.
  5. Desai A, Kulkarni A, Rajkumar SV, Gyawali B. Clinical Trial End Points in Severe COVID-19. Mayo Clin Proc. 2020 Aug;95(8):1578-1580. Epub 2020 Jun 6.
  6. Fisher AC, Viehmann A, Ashtiani M, Friedman RL, Buhse L, Kopcha M, Woodcock J. Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US. JAMA Netw Open. 2020 Aug 3;3(8):e2013920.
  7. Fralick M, Bartsch E, Ritchie CS, Sacks CA. Estimating the Use of Potentially Inappropriate Medications Among Older Adults in the United States. J Am Geriatr Soc. 2020 Aug 25. Epub ahead of print.
  8. Fralick M, Bartsch E, Darrow JJ, Kesselheim AS. Understanding when real world data can be used to replicate a clinical trial: A cross-sectional study of medications approved in 2011. Pharmacoepidemiol Drug Saf. 2020 Aug 14. Epub ahead of print.
  9. Handelsman DJ. Pharmacoepidemiology of testosterone: Impact of reimbursement policy on curbing off-label prescribing. Pharmacoepidemiol Drug Saf. 2020 Aug 2. 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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