ivanoransky
Embargo Watch
1/28/2011
Last week, the FDA announced changes to its medical device approval process, aka 510(k) clearance, which has been the source of complaints from many in the industry. But as the embargo lifted at 1 p.m. Eastern on January 19, all you saw in the media were brief stories like this one. It took a little while before you could get any reaction from industry or other players.
Here’s why: On January 19, a few hours before the embargo lifted, the FDA’s Karen Riley, of the Office of Public Affairs, wrote the following (FYI, it was not me at Reuters asking):
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.
Actually, it does need some saying, since this is a new version of a journalistic embargo…
The article continues at Embargo Watch.
H/T Alliance for Natural Health
…In response to the FDA’s statement, the nonprofit Association of Health Care Journalists (AHCJ)—the nation’s largest group of health reporters—sent a strongly worded letter to the FDA, objecting to the administration’s “highly unusual” new policy: “[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.”
The group continued, “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.”
As an example of what the FDA is trying to accomplish with this outrageous new policy, take a look at this in-depth article published the day the aforementioned medical device approval announcement was made: 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….
