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

By Ameet Sarpatwari, Charlie Lee, 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 pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from the cost of delayed generic entry in Medicaid, to challenges with false negative tests for SARS-CoV-2 infection, to difficulties in implementing and enforcing state opioid prescribing laws. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Darrow JJ, Chong JE, Kesselheim AS. Reconsidering the scope of US state laws allowing pharmacist substitution of generic  drugs. BMJ. 2020 June;369:m2236. (PMID: 32576554).
  2. Dave C V, Sinha MS, Beall RF, Kesselheim AS. Estimating The Cost Of Delayed Generic Drug Entry To Medicaid. Health Aff (Millwood). 2020 June;39(6):1011-1017. (PMID: 32479219).
  3. Koch C, Schleeff J, Techen F, et al. Impact of physicians’ participation in non-interventional post-marketing studies on  their prescription habits: A retrospective 2-armed cohort study in Germany. PLoS Med. 2020 June;17(6):e1003151. (PMID: 32589633).
  4. Naci H, Kesselheim AS. Specialty Drugs – A Distinctly American Phenomenon. N Engl J Med. 2020 June;382(23):2179-2181. (PMID: 32492301).
  5. Sarpatwari A, Kaltenboeck A, Kesselheim AS. Missed Opportunities on Emergency Remdesivir Use. JAMA. 2020 June 24. [Epub ahead of print] (PMID: 32579163).
  6. Sinha MS, Bourgeois FT, Sorger PK. Personal Protective Equipment for COVID-19: Distributed Fabrication and Additive Manufacturing. Am J Public Health. 2020 June;110(8):1162-1164. (PMID: 32552025).
  7. Stone EM, Rutkow L, Bicket MC, Barry CL, Alexander GC, McGinty EE. Implementation and enforcement of state opioid prescribing laws. Drug Alcohol Depend. 2020 Jun 11;213:108107. [Epub ahead of print] (PMID: 32554171).
  8. Vijay A, Gupta R, Liu P, Dhruva SS, Shah ND, Ross JS. Medicare Formulary Coverage of Brand-Name Drugs and Therapeutically Interchangeable Generics. J Gen Intern Med. 2020 June;35(6):1928-1930. (PMID: 31625043).
  9. Woloshin S, Patel N, Kesselheim AS. False Negative Tests for SARS-CoV-2 Infection – Challenges and Implications. N Engl J Med. 2020 June 5. [Epub ahead of print] (PMID: 32502334).

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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