Tuesday, July 01, 2008

FDA Steps Up Security for Advisory Committees

FDA advisory committee meetings are not supposed to be like episodes of the Jerry Springer show.

And for good reason: One is a scientific discussion of the benefit-risk profile of new drug or indication. The other is a television tabloid talk show with topics in such poor taste that our own corporate content filters won’t even let us access the website.

But it was Springer-like behavior at a recent meeting (featuring a threatening rant by an apparently intoxicated speaker during the open public hearing) that led FDA to impose new security measures to protect the agency’s expert panelists. While FDA hasn’t made a formal announcement of the policy changes, Office of New Drug Director John Jenkins discussed the new procedures at the Drug Information Association’s annual meeting last week.

“We have put in place some new measures to help improve security at meetings,” Jenkins said. “If we anticipate that there may be an increased need for security at a particular meeting because it is a particularly controversial topic, we may have additional security procedures.”

Those procedures include:

1) Creating a physical barrier by roping off the committee from the public. The intent, Jenkins said, is “to put some separation between those who might become agitated in the audience and committee members.” (For taxpayers, it carries another benefit—preventing the public from sneaking pastries off the committee’s breakfast tray.)

2) Increasing the presence of security guards in the committee room—both in uniform and street clothes.

3) Reading a statement at the start of the meeting about “good rules of behavior.”

There have been kerfuffles at advisory committees before, especially when the drug under review would be used to treat a rare or life-threatening condition. The heckling of FDA commissioner David Kessler during the 1996 advisory committee review of Abbott’s ritonavir, the first protease inhibitor for HIV, comes to mind.

And in very rare cases, FDA takes extraordinary steps to protect committee members. That same year, the review of the abortifacient RU-486 was held in an unused warehouse in the middle of a remote industrial park in Maryland. Attendees (or at least the press) were asked to park up to a half-mile away and walk into the meeting.

But this is the first time that FDA has felt the need for a comprehensive plan to ensure the security of advisory committee members. And it’s the biggest change to the advisory committee process since the agency altered its conflict of interest guidelines last year.

The trigger was a May 2007 review of IDM’s mifamurtide (Junovan) for the treatment of osteosarcoma. During the open public meeting, an apparently intoxicated individual made threatening statements to University of Michigan’s Maha Hussain, and was ultimately removed from the room. (You can read FDA’s official transcript of that exchange here.)

Later in the meeting, Hussain and other committee members pointedly suggested that FDA establish greater security measures. (Hussain, it should be noted, has had her share of controversy in committee rooms. Last year, she was also one of four votes against the approval of Dendreon's Provenge, a decision that led to threatening e-mails, phone calls and letters.)

For drug sponsors, the new procedures aren’t likely to have significant practical implications. But they are indicative of the intense public interest in drug development, and the pressure to discover new cures and keep unsafe products off the market.

We should note that the majority of meetings aren’t controversial and hence don’t require significant security procedures. But, as Jenkins noted, “there have been some incidents where that decorum has not sustained itself, and we’ve felt the need to institute procedures to maintain the safety of our advisors.”

Hence the rope. Of course, roping off the public isn’t the only way FDA can ensure the safety of those present at advisory committee meetings. Given some of the disputes between FDA officials on drug safety issues (remember the Arcoxia meeting? The Avandia meeting?), perhaps that rope could be put to better use elsewhere.

Wouldn’t that make a good Springer show?

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