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Health Care Policy and Law
August 2018

Reviving the FDA’s Authority to Publicly Explain Why New Drug Applications Are Approved or Rejected

Author Affiliations
  • 1Health Law Institute, Department of Pharmacology, Faculties of Medicine & Law, Dalhousie University, Halifax, Nova Scotia, Canada
JAMA Intern Med. 2018;178(8):1013-1014. doi:10.1001/jamainternmed.2018.3137

In January 2018, Scott Gottlieb, the Commissioner of the US Food and Drug Administration (FDA), stated that the agency would “look for ways to be more forthcoming with the information” it holds “within the boundaries” of its governing laws.1 Gottlieb announced a voluntary initiative under which the agency would begin to publish clinical study reports prepared by companies in support of new drug applications. Clinical study reports summarize the protocols and findings from all clinical studies for a given drug thus providing more detail about a drug’s safety and effectiveness than is often found in the medical literature.2 Gottlieb also announced a related initiative to integrate clinical trial identifiers, used in Clinicaltrials.gov and other trial registries, into FDA documentation, including advisory committee materials, approval letters, and product labels.

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