Large pile of amber prescription pill bottles

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) go through recent, 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 July. The selections feature topics ranging from an assessment of excess prescription drug spending associated with delayed generic competition, to an analysis of the differences between the use of advisories by drug regulatory bodies in various countries, to a commentary on the pitfalls of using SSR Health data for estimating net prescription drug spending. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RF, Ronksley P, Wick J, Darrow J, Sarpatwari A, Kesselheim AS. Comparing Onset of Biosimilar Versus Generic Competition in the United States. Clin Pharmacol Ther. 2020 July 4. Epub ahead of print.
  2. Guadamuz JS, Qato DM, Alexander GC. Use of Risk Evaluation and Mitigation Strategies by the US Food and Drug Administration, 2008-2019. JAMA. 2020 Jul 21;324(3):299-301.
  3. Johnston JL, Dhruva SS, Ross JS, Rathi VK. Early experience with the FDA’s Breakthrough Devices program. Nat Biotechnol. 2020 Jul 23. Epub ahead of print.
  4. Lauenroth VD, Kesselheim AS, Sarpatwari A, Stern AD. Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany. Health Aff (Millwood). 2020 Jul;39(7):1185-1193.
  5. MacGregor A, Zhang AD, Wallach JD, Ross JS, Herder M. Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015. JAMA Netw Open. 2020 Jul 1;3(7):e209498.
  6. Perry LT, Bhasale A, Fabbri A, Lexchin J, Puil L, Joarder M, Mintzes B. A descriptive analysis of medicines safety advisories issued by national medicines regulators in Australia, Canada, the United Kingdom and the United States – 2007 to 2016. Pharmacoepidemiol Drug Saf. 2020 Jul 21. Epub ahead of print.
  7. Rome BN, Feldman WB, Kesselheim AS. Drug Prices, Rebates, and Discounts. JAMA. 2020 Jul 28;324(4):399.
  8. Rome BN, Lee CC, Kesselheim AS. Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012-2018. Clin Pharmacol Ther. 2020 Jul 12. Epub ahead of print.
  9. Rome BN, Tessema FA, Kesselheim AS. US Spending Associated With Transition From Daily to 3-Times-Weekly Glatiramer Acetate. JAMA Intern Med. 2020 Jul 20. Epub ahead of print.
  10. Talebi R, Redberg RF, Ross JS. Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA. Trials. 2020 Jul 23;21(1):675.
Ameet Sarpatwari

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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