Tag Archives: embargo

AHCJ adds to its ethical framework for journalists’ decisions

values-definitionAHCJ’s board of directors has voted unanimously to add a new item to its Statement of Principles, the association’s compendium of professional and ethical guidelines.

These principles lie at the core of AHCJ’s mission to promote the highest standards of health care journalism, and have been little changed since the organization was founded.

Adding a new principle is a significant move that may prove especially relevant in the years ahead. Continue reading

FDA bans ‘close-hold embargoes’ in response to AHCJ protest

usfda-logoThe Food and Drug Administration has banned a communications practice that troubled journalists and sparked protests from AHCJ and others.

The agency has forbidden its media staff from using “close-hold embargoes,” in which reporters receive early access to information provided they promise not to seek comments from others until the embargo lifts, according to a letter sent Thursday to Karl Stark, president of the Association of Health Care Journalists. Continue reading

AHCJ objects to FDA’s ‘close-hold embargoes,’ requests explanation

Image by Logan Campbell via flickr.

Image by Logan Campbell via flickr.

AHCJ is protesting the Food and Drug Administration’s recent restrictive practices in handling news embargoes and has asked the agency for clarification of its policies.

In an Oct. 11 letter to Jason Young, the FDA’s acting assistant commissioner for media affairs, AHCJ President Karl Stark raised strong objections to the practice of providing embargoed information on the condition that reporters refrain from seeking outside comment until the embargo lifts. Continue reading

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.”

AHCJ asks FDA to re-evaluate embargo policy

The Association of Health Care Journalists has sent a letter to FDA officials asking them to re-examine a policy that prohibits reporters from sharing embargoed materials with sources before the embargo lifts for the purpose of obtaining outside comment and context. As AHCJ notes, this highly unusual policy severely limits the ability of reporters to give readers the full story of a federal agency.

From the letter:

The restriction imposed on the medical-device announcement rewrote a longstanding compact between reporters and various public and scientific organizations. It also hampered or delayed reporters’ ability to fully inform the public about what the FDA is doing with taxpayers’ money. The early reports on the medical device approval process were brief and uninformative as a result.

Read the complete letter.

We will be sure to update readers if AHCJ receives a response from the FDA.