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 June. The selections feature topics ranging from the utilization of medical devices necessary to detect post-approval safety differences, to evidentiary standards and regulatory tradeoffs in the FDA’s expedited approval programs, to the president’s plan to address high drug prices. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li SX, Marinac-Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiol Drug Saf. 2018 Jun 12. [Epub ahead of print].
  2. Bekelman JE, Joffe S. Three Steps Toward a More Sustainable Path for Targeted Cancer Drugs. JAMA. 2018 Jun 5;319(21):2167-2168.
  3. Dhruva SS, Ross JS, Schulz WL, Krumholz HM. Fulfilling the Promise of Unique Device Identifiers. Ann Intern Med. 2018 Jun 5. [Epub ahead of print].
  4. Fralick M, Avorn J, Franklin JM, Bartsch E, Abdurrob A, Kesselheim AS. Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety.  Gen Intern Med. 2018 Jun;33(6):792-794.
  5. Gerrity MS, Prasad V, Obley AJ. Concerns About the Approval of Nusinersen Sodium by the US Food and Drug Administration. JAMA Intern Med. 2018 Jun 1;178(6):743-744.
  6. Sarpatwari A, Avorn J, Kesselheim AS. An Incomplete Prescription: President Trump’s Plan to Address High Drug Prices. JAMA. 2018 June 19;319(23):2373-2374.
  7. Wallach JD, Ross JS, Naci H. The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements. Clin Trials. 2018 Jun;15(3):219-229.

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