Thursday, March 06, 2008

FDA’s Risk Communication Advisory Committee: An Ineffective Beginning

If you’re an executive for a company with an FDA-regulated product, the agency’s inaugural Risk Communication Advisory Committee meeting had to make you a little nervous.

Granted this was the first time the group was brought together so you’d expect some wandering by the committee. Still, there was a lot of wandering. And the last thing the industry or the agency needs is more unknown variables thrown into the risk communication equation. From the hour-long introductions on the first day to the back-and-forth open public hearing portion of the meeting, the committee was like a Super Bowl half-time show gone bad. There appeared to be little focus on any particular area of discussion and much of the conversations between panelists lacked meaningful direction—a telltale sign of a bad committee.

Here’s the issue for biopharma companies: FDA typically follows advisory committee recommendations, although they certainly aren’t required to. With a committee this inexperienced and seemingly unfamiliar with FDA regulations, procedures and protocols, how will their opinions be interpreted into final risk communication decisions? How will the media report recommendations from a newborn committee that may be clearly out of whack with FDA standard procedures?

The Institute of Medicine’s report on drug safety called for the creation of a risk communication advisory panel similar to FDA’s other scientific drug review committees except focused on how FDA should best communicate safety and risk-related issues to the public.

In other words, how to alert the public without alarming them. To read our initial story on the new committee, click here.

What FDA, and the drug industry for that matter, really requires from this committee is a strong group of advisors to provide practical guidance to FDA on how to address risk concerns quickly, proportionally to the risk presented with new information emerging continuously. If the inaugural meeting serves as any guidepost, FDA won’t be getting that guidance.

The agency has had a mixed record recently dealing with these types of situations. In May, FDA was criticized heavily for reacting too slowly to the publication of meta-analysis data on GlaxoSmithKline’s diabetes drug Avandia showing more than a 40% increased risk of heart attack associated with patients using the drug. In fact, the House Committee for Oversight and Government Reform was able to announce a hearing before FDA could even respond to the analysis with a press release or conference call. We all know how that turned out.

Then there was a rather awkward “early communication” call in August with the media over potential cardiovascular risks linked to AstraZeneca’s blockbuster proton pump inhibitor Nexium found in two small studies. But after discussing the possible risks uncovered by the trials, the agency said on the same call there were no risks related to Nexium. “FDA has concluded preliminarily that these data do not suggest an increased risk of heart problems for patients treated with either of these products,” Center for Drug Evaluation and Research associate director for safety policy and communication Paul Seligman said.

The Nexium communication was followed by a January “early communication” briefing by FDA on Merck/Schering-Plough’s ENHANCE study of the cholesterol combo drug Vytorin almost two weeks after data from the study were made public by the companies and commented on at length by cardiologist Steve Nissen in the mainstream media.

On the call, FDA officials summarized the results already made public by Schering-Plough, and said it would review the data fully once it is submitted by the sponsor. To read a recap, click here.

The risk communication committee is supposed to help FDA avoid situations like that. What the agency appears to have on its hands, though, is a motley crew of experts with very different fields of expertise who don’t necessarily fit together or fit the purpose they were meant to serve—at least based on the initial two-day meeting.

The purpose of this first meeting was not to make specific recommendations on a specific product or issue but rather a more general discussion of risk communication. So there will be wandering. What should be alarming to drug companies, however, is how pronounced the absence of direction was during question and answer sessions and the level of inexperience displayed by individual panelists.

FDA senior risk communication advisor Nancy Ostrove explained in her overview presentation to the panel that this particular committee is supposed to be different. But in this case, different does not necessarily mean better.

The open public hearing encapsulated how the two-day meeting went. A free-lance reporter spoke endlessly (public speakers are generally given five minutes to make a statement during advisory committee meetings, this went way over) about how reporters used to be able to interact directly with FDA officials but now must go through the press office to seek permission to speak with an official and often aren’t granted access. Committee chairman Baruch Fischhoff, Carnegie Mellon, and other panelists engaged in a prolonged Q&A session with the speaker. It was painful.

Not everything was bad. FDA assistant commissioner for accountability and integrity William McConagha delivered a clear and important presentation on legal authorities and protections related to the First Amendment and communicating risk. One interesting suggestion to come out of the meeting from consultant Steve Gorelick, Hunter College, was that FDA hold a daily media briefing similar to the Pentagon.

All in all, though, the first risk communication panel meeting was a dud. Although it takes time for FDA advisory committees to develop personality and voice, this is one committee that won’t be afforded the time to do that. With arguably unprecedented public scrutiny of FDA and the next drug safety event around the corner, the agency will need to mine the expertise of the panel—sooner rather than later.

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