Reviving FDA's authority to publicly explain why new drug applications are approved or rejected

FDA pledged earlier this year to increase transparency, such as by incorporating clinical trial identifiers into agency documentation.

FDA pledged earlier this year to increase transparency, such as by incorporating clinical trial identifiers into agency documentation. While possibly providing insight on drug approval decisions, Matthew Herder, JSM, LLM, of Dalhousie University in Nova Scotia, Canada, notes that such action will not provide additional clarity on why FDA rejects a new intervention. The regulator claims that laws protecting trade secrets and confidential commercial information prevent it from sharing these details with the public, but Herder, with Dalhousie's pharmacology department, blames FDA's interpretation of those laws instead. Over the years, he writes, the agency has selectively used the Freedom of Information Act to increase disclosures at times and to restrict them during others. Any steps to improve transparency in recent decades have been forced by new legislation or even litigation, rather than generated from FDA's own efforts. A pilot program launched in March could signal a move in the other direction, however. While the initiative—which encourages the disclosure of clinical study reports on a voluntary basis—is welcomed, Herder emphasizes that FDA could also use its existing authority to divulge more information about drug approvals/rejections to the public. Under governing laws, he explains, the agency still has the power to disclose summary-level data for approved new drug applications as well as safety and efficacy data for new drug applications that are abandoned, rejected, or withdrawn.