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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Biotechnology, Frazer Tessema, Generic Drugs, Health Law Policy, Medicare/Medicaid, Opioid Crisis, Pediatrics, 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 in the Division.

Below are the abstracts/summaries for papers identified from the month of August. The selections feature topics ranging from legislation to promote pediatric drug research, to the accelerated approval of immune-checkpoint inhibitors, to the rates of coprescribing of opioids and benzodiazepines after the release of CDC guidelines in 2016. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bourgeois FT, Kesselheim AS. Promoting Pediatric Drug Research and Labeling – Outcomes of Legislation. N Engl J Med. 2019 Aug 29;381(9):875-881.
  2. Egilman AC, Zhang AD, Wallach JD, Ross JS. Medicare Part D Spending on Single-Enantiomer Drugs Versus Their Racemic Precursors. Ann Intern Med. 2019 Aug 13. [Epub ahead of print]
  3. Gill J, Prasad V. A reality check of the accelerated approval of immune-checkpoint inhibitors. Nat Rev Clin Oncol. 2019 Aug 5. [Epub ahead of print]
  4. Growdon ME, Sacks CA, Kesselheim AS, Avorn J. Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers. JAMA Intern Med. 2019 Aug 5. [Epub ahead of print]
  5. Gyawali B, Tessema FA, Jung EH, Kesselheim AS. Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis. JAMA Netw Open. 2019 Aug 2;2(8):e199570.
  6. Jeffery MM, Hooten WM, Jena AB, Ross JS, Shah ND, Karaca-Mandic P. Rates of Physician Coprescribing of Opioids and Benzodiazepines After the Release of the Centers for Disease Control and Prevention Guidelines in 2016. JAMA Netw Open. 2019 Aug 2;2(8):e198325.
  7. San-Juan-Rodriguez A, Good CB, Heyman RA, Parekh N, Shrank WH, Hernandez I. Trends in Prices, Market Share, and Spending on Self-administered Disease-Modifying Therapies for Multiple Sclerosis in Medicare Part D. JAMA Neurol. 2019 Aug 26. [Epub ahead of print]
  8. Zhai MZ, Sarpatwari A, Kesselheim AS. Why Are Biosimilars Not Living up to Their Promise in the US? AMA J Ethics. 2019 Aug 1;21(8):E668-678.

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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