FDA creates embargo policy in response to reporter concerns


The Food and Drug Administration has adopted a policy on embargoes that permits reporters to share embargoed information with outside sources, provided the sources agree to uphold the embargo.

The policy explicitly supports embargoes as a way for reporters to add depth and detail to their stories, and conforms to common practice among medical journals and other sources of complex information.

The policy was shared with AHCJ this week after complaints from the organization earlier this year. In January, the FDA barred reporters from interviewing experts about new regulations on medical devices until the embargo lifted. AHCJ wrote to the FDA that such an approach created obstacles to serious journalism.

In an embargo, the group releasing information chooses the time and date that it will be made public, and reporters get an advance look as long as they agree to delay publication or broadcast until that time. Reporters are willing to do this because it allows time digest the information and seek comments from experts.

In a letter this week to AHCJ, the FDA outlined its policy going forward:

“A journalist may share embargoed material provided by the FDA with non-journalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third-party to uphold the embargo.”

The letter, from Meghan H. Scott, FDA’s acting associate commissioner for external affairs, said the FDA did not previously have a policy on embargoed news. After AHCJ’s inquiry, she wrote, the media staff met with AHCJ members, other journalists, and editors of medical and scientific journals as it worked to develop a policy.

“The FDA is committed to a culture of openness in its interaction with the news media and the public,” Scott wrote to Charles Ornstein, AHCJ president, and Felice Freyer, chair of AHCJ’s Right to Know Committee.

She specified that the FDA may provide embargoed information when:

  • the issue is not related to regulatory or enforcement issues and does not contain confidential, commercial information; and
  • the subject is complex or technical and early access to materials and subject matter experts will help reporters prepare their articles in a timely, accurate manner with the context needed to understand the material.

“We’re grateful that the FDA media staff took the time to study the issue and develop a suitable policy,” Freyer said. “The results are clear rules that are reasonable and workable – and a step forward in improving relations between the FDA and the media.”

Creative Commons License

Republish our articles for free, online or in print, under a Creative Commons license.