FDA's Real Risk Communication Challenge

FDA is the first to admit that it hasn’t quite figured out the best way to communicate drug risks to patients—especially how to convey emerging risk information without scaring patients away from a helpful or life-saving treatment.

But it is also clear that FDA hasn’t quite figured out how to communicate within the agency on communicating risk to patients, either.

On Friday, FDA announced a major new policy on risk communication under which it will begin alerting the public to potential safety problems with a drug or biologic at the very beginning of the post-marketing drug safety process. (Check here for our earlier take on that initiative.)

On Monday, FDA’s senior advisor on risk communication in the Office of the Commissioner, Nancy Ostrove, spoke at the Food & Drug Law Institute’s annual meeting on advertising and promotion.

Given that the title of Ostrove’s speech was “FDA’s Initiatives in Communicating Risk Information,” it appeared to be the perfect venue for discussing the new program—so much so that one might have wondered whether the agency timed the announcement to coincide with Ostrove’s FDLI presentation.

Apparently not.

After avoiding mention of the program in her opening remarks, Ostrove gave the following disclaimer before the question and answer session: “I can tell you one thing I am not going to talk about…the press release that went out on Friday concerning the FDAAA provisions on quarterly reports. I didn’t even get it until today. So I can’t talk about it.”

Given the pains that FDA took in announcing the decision—a rare embargoed media call ahead of the official announcement with Office of Drug Safety director Gerald Dal Pan and Safety Policy & Communication associate director Paul Seligman—it was surprising that Ostrove wasn’t on the call herself, or, at the very least, aware that it had taken place.

There may be good reasons for Ostrove not to have been in on that decision. But given FDA’s recent focus on risk communication (check out our coverage in The RPM Report here and here), we can’t help but wonder whether the real communication on risk needs to first take place at FDA.

image from flickr user rubatacchini used under a creative commons license