Title

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

Document Type

Article

Publication Date

2018

Keywords

Law & Medicine, Regulatory Agencies

Abstract

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. 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. 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.

Together, these initiatives have the potential to substantially improve the transparency of FDA decisions, but only for drugs that are granted marketing approval. The initiatives do not extend to the FDA’s reasons for not approving drugs; these are communicated to companies in what are known as complete response letters, and would remain confidential. The omission of complete response letters is puzzling given that there is a compelling public health rationale for making them public. In 2015, the FDA’s own research showed that company press releases, which often provide the only public information about the content of complete response letters, frequently fail to include clinically relevant information, such as agency concerns about higher mortality linked to the study drug.

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