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FDA's new embargo policy amounts to gag order on journalists

by Chris Hinyub, published

A free and diffuse press has always been the boast of the United States government to less "democratized" nations. But recently, the veneer of transparency has been flaking off, exposing a system of information sharing about policy decisions that is more regulated and censored than previously thought.


Federal agencies need to inform the public, somehow, about how they are going to amend the rules of commercial exchanges. These announcements are formalized with press releases, but the information is sent to various press groups beforehand with a legal understanding, or embargo, not to disseminate before a set time. In the interest of fairness, journalists are given the opportunity to investigate the information given them and write stories based on whatever input they can glean from experts. Any outside party must agree to the non-disclosure agreement if they want to give their opinion. Health news reporters relied on this standard industry practice to remain competitive and timely with their work until the Food and Drug Administration (FDA) decided to impose some unusual restrictions.


Back in January, when the FDA was set to unveil a new approval process for medical devices – otherwise known as 510 (k) clearance – the FDA's Karen Riley issued this statement to journalists a few hours before the gag order ended on the 19th:


     “Reuters is asking, so I am clarifying. It goes without saying that the embargo means YOU CANNOT call around and get comment ahead of the 1 p.m. embargo. Needless to say, that would effectively break the embargo.”


Confusion immediately took hold of the press. How could this breach of protocol “go without saying?” Responding to Riley's statement, the Association of Health Care Journalists (AHCJ) – the nation's largest organization of health reporters – sent a stern letter of objection to the FDA stating in part:


     “[This] restriction…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.”


If reporters want to remain competitive on a story, the group continued, they will have to essentially become stenographers for the FDA, parroting their rationale behind policy changes without analysis or outside commentary.


Embargo Watch, a blog that keeps an eye on how scientific information embargoes affect news coverage, had this to say:


     “If that’s what the FDA — a public agency — wants, they need to rethink. And if they insist that this is what they mean by a journalistic embargo, then I’d suggest reporters stop agreeing to them. There’s really no benefit to reporters or the public, only to the FDA.”


For a good example of what is to be expected of forthcoming FDA press releases, take a look at this article issued on the same day that the aforementioned medical device approval embargo ended. The international organization Alliance for Natural Health observed that:


      “a major policy change with potentially huge safety ramifications was covered in seventy-seven little words. Dull, absurdly brief, and decidedly uncontroversial—exactly what the FDA wanted.”


Last week, AHCJ leaders met with top press officials at the Department of Health and Human Services for clarification on the new embargo policy. Beth Martino, associate commissioner for external affairs at the FDA, said that the she was “evaluating the FDA's embargo policy and asking other organizations about theirs.” Martino said she would issue an official response in the coming weeks.

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