FDA wants stenographers? Agency says reporters can’t interview anyone before its embargo lifts

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. Cardiobrief’s Larry Husten wrote to Riley in response:

Just for future reference I strongly suggest you rethink this policy. From everything that I understand, the major purpose and best rationale for an embargo is to allow reporters to get a deeper perspective on a complex story. By necessity this often entails asking other experts in the field. Of course, these experts need to be apprised of the embargo and they need to agree to its terms.

I’m guessing you’ve heard similar points from other reporters…

As Husten notes, one of the main reasons for embargoes — at least, if you take journals at face value — is to allow for better, more informed coverage. Part of how that coverage happens is that reporters can go interview sources other than the embargoing institution.

Without that, journalists become stenographers. 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.

I’ve tried to reach Riley, and will update if I hear back.