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AHCJ asks FDA to re-evaluate embargo policy Date: 02/14/11

COLUMBIA, Mo. – 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.

Here is the letter AHCJ has sent to the FDA:

Beth Martino
Associate Commissioner for External Affairs
U.S. Food and Drug Administration

Feb. 9, 2011

Beth,

The Association of Health Care Journalists, the nation's largest group of health reporters, strongly objects to the FDA's recent position on embargoed news. When announcing the FDA's new policies on medical-device approvals, FDA press officers barred reporters from seeking comment from informed experts and commentators before the embargo lifted.  

We'd like to know whether the FDA intends to maintain this unusual policy for future embargoes. If so, we would urge you to abandon embargoes altogether and simply release the information to all parties at once.

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.

Embargoes are a system based on mutual trust. The group wishing to release 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 the embargo lifts. Reporters are willing to do this because the embargo allows them time to prepare more complete and meaningful stories. An essential part of that preparation is contacting others who can evaluate the new information.

If the FDA continues to prohibit such reporting, the restriction will be a serious obstacle to good journalism. Reporters who want to be competitive on a story will essentially have to agree to write only what the FDA wants to tell the world, without analysis or outside commentary. Such a policy would be disturbing coming from a public agency, especially one that has pledged to increase transparency.

The FDA's stance on the medical device announcement was noted in the Embargo Watch blog, which is written by AHCJ's treasurer, Ivan Oransky. Oransky reported on the decision because it surprised and distressed reporters around the country, including our members. AHCJ represents more than 1,000 print, broadcast and online journalists and we are writing on their behalf.

The FDA's position ran contrary to common practice. For example, the journal Nature describes its embargo terms as follows: "Solely for the purpose of soliciting informed comment on Nature papers, you may show relevant parts of this document, and the papers to which it refers, to independent specialists – but you must ensure in advance that they understand and accept Nature's embargo conditions."

The New England Journal of Medicine's embargo policy describes the purpose of embargoes:  "There are two fundamental reasons for our embargo: it allows the media time to report accurately on complex and important new research findings, and it allows subscribers to read and understand the full reports in NEJM before media reports on them appear, which often leads patients to ask their physicians for interpretation and guidance."

We'd like to inform AHCJ members whether the FDA will continue to bar reporters from consulting outside experts about embargoed news. Please get back to us within two weeks to clarify your policy on embargoes.

Thank you,

Charles Ornstein, AHCJ President

Felice Freyer, Chair, AHCJ Right to Know Committee

cc: Richard Sorian, HHS