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

By Ameet Sarpatwari, Michael S. Sinha, 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 September. The selections feature topics ranging from the impact of the FDA Amendments Act of 2007; to the estimated cost of pivotal trials for FDA-approved novel therapeutic agents, to labeling changes and costs for clinical trials performed under the FDA pediatric exclusivity extension. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Avorn J, Kesselheim A, Sarpatwari A. The FDA Amendments Act of 2007 – Assessing Its Effects a Decade Later. N Engl J Med. 2018 Sep 20;379(12):1097-1099.
  2. Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH. Changes in Drug Pricing After Drug Shortages in the United States. Ann Intern Med. 2018 Sep 18. [Epub ahead of print]
  3. Moore TJ, Zhang H, Anderson G, Alexaner GC. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration. JAMA Intern Med. 2018 Sep 24. [Epub ahead of print]
  4. Nishikawa G, Prasad V. Diagnostic expansion in clinical trials: myocardial infarction, stroke, cancer recurrence, and metastases may not be the hard endpoints you thought they were. BMJ. 2018 Sep 19;362:k3783.
  5. Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS. Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012. JAMA Intern Med. 2018 Sep 24. [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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