Tag Archives: embargo

FDA creates embargo policy in response to reporter concerns

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

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

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

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.

Policy lets many see study but restricts reporting

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

On his new blog, Embargo Watch, Ivan Oransky, M.D., writes about an embargo policy that restricts journalists from writing about papers even when they are widely available to doctors, medical schools and hospitals.

Oransky, who is treasurer of AHCJ’s board and executive editor of Reuters Health, has written about embargoes before for Covering Health and TheScientist.com, questioning whether embargoes are serving the public, the scientific journals or journalists.

In this case, The American Journal of Respiratory and Critical Care Medicine placed an embargo on a study it made available “through HighWire, a Stanford University service that many publishers use to make electronic versions of their journals available.”

This was a new one for me. Embargoed papers not being available to anyone but the press, sure. But available to many doctors — and anyone doctors showed them to — for two weeks before we could write about them?

Oransky discussed the policy with the director of communications and marketing at the American Thoracic Society, which publishes AJRCCM, and reports on the response from him as well as from other public relations professionals and reporters.

One particularly interesting comment points out that investors are likely seeing studies release on HighWire, perhaps giving some an unfair advantage financially.

Tech journalists question future of embargoes

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

At last week’s “Embargo 2010: An Industry Conversation on Future Rules of Media Engagement,” tech journalists convened to discuss the viability of embargoes in an increasingly fluid media universe.

arrington
TechCrunch founder and editor Michael Arrington. Photo by jdlasica via Flickr.

Update: Follow the debate as it evolves on Twitter, either on this handy site or with the #embargo2010 hashtag.

The discussion seems to have been spurred by the anti-embargo grandstanding of TechCrunch founder and editor Michael Arrington, who canceled a planned appearance on the panel despite his well-publicized penchant for breaking embargoes. Threatened by embargo scofflaws like Arrington, many seemed to believe the embargo system was on its way out, and they saw a number of possible replacements. The consensus centered around two options:

  • Press conferences: This is already the prevailing model in the UK. Everyone gets the information at once, though a big conference is announced, there’s a general impression that somebody, somewhere will find a way to get the info early anyway. The downside, of course, is that folks don’t get as much time to prep their reports.
  • Exclusives: For the lucky outlet, exclusives are great. They get plenty of time to prepare and a jump on the story. They’re not as popular with everyone else, for obvious reasons.

Update: Read BayNewser’s E.B. Boyd’s recap (complete with photos) here. Boyd emphasizes the interplay between public relations professionals and journalists.

Tech versus health

Web PR man Shel Holtz rebuts Arrington’s anti-embargo stance, claiming that tech journalism is a special case and that, in other arenas (he specifically cites health journalism), they are going nowhere. His post includes audio from an embargo-related conversation with Mayo Clinic media relations chief Karl Oestreich.

Related

AHCJ lodges protest over handling of embargo

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

The Association of Health Care Journalists has followed up on concerns about how an embargo was handled earlier this month by several federal agencies and a medical journal.

The organization sent letters this week to several federal agencies and a medical journal objecting to the uneven handling of embargoed news. The letters were addressed to officials at the National Institute of Mental Health, the Department of Health and Human Services, the Centers for Disease Control and Prevention and the American Academy of Pediatrics to protest the recent handling of embargoes on two autism studies. AHCJ is asking the agencies and academy to clarify embargo policies, saying that once an embargo is broken – once the news is out in any public forum, whether it’s a radio report, a public meeting, a Web site or a newspaper – the embargo must be lifted.

Read the full press release and the letters that were sent: