The advent of FDA's Drug Safety Oversight Board will likely lead to an increase in the number of advisory committee meetings, Center for Drug Evaluation & Research Acting Director Steven Galson said at a meeting of FDA's Science Board April 15.

"I expect we will have more advisory committee meetings on specific drug safety issues over the next few years as the board gets going," Galson said.

"Nothing that we're doing here in setting up the board is meant to diminish the role of our advisory committees."

[Editor's Note: To ¹ watch a webcast of the Science Board meeting, visit FDAAdvisoryCommittee.com.]

In recent years, FDA has scheduled increasingly fewer advisory committee meetings (² [A#00660520006], p. 42).

FDA Acting Commissioner Lester Crawford told a recent Generic Pharmaceutical Association meeting that the agency was interested in involving the advisory committee chairs in the activities of the drug safety board (³ Also see "FDA Drug Safety Oversight Board May Include Advisory Committee Chairs" - Pink Sheet, 7 March, 2005., p. 10).

Galson elaborated on the role that advisory committee members will play in the drug safety board's work.

Committee chairs and members will be asked to serve as consultants, Galson said. As such, they will likely be asked to compose position papers and to make presentations to the oversight panel.

The drug safety board will include members from relevant CDER offices, the Center for Biologics Evaluation & Research and the Center for Devices & Radiological Health, Galson said.

The board will be chaired by the CDER Deputy Director. Division of Cardio-Renal Drug Products Director Douglas Throckmorton currently holds the CDER deputy director position on an acting basis, making him the first chair of the oversight panel.

CDER Division of Pediatric Drug Development Lead Medical Officer Susan Cummins will serve as the board's executive director. Cummins recently completed a detail in the Office of Pediatric Therapeutics in the Office of the Commissioner.

It is understood that the oversight board will include three voting members each from the Office of New Drugs and the Office of Drug Safety.

FDA Office of Medical Policy Director Robert Temple is understood to be a member of the committee. Temple is also Office of Drug Evaluation I Director; he is likely to be a non-voting member so that the OND/ODS ratio is not changed.

Drug safety board members will not be allowed to participate in votes concerning products about which they previously made regulatory decisions, Galson said.

Throckmorton would presumably then be excluded from voting were the board to discuss emerging safety issues regarding Johnson & Johnson's congestive heart failure agent Natrecor (see ⁴ Also see "Natrecor Labeling Revised To Include Expanded Mortality Analysis" - Pink Sheet, 25 April, 2005.).

The board will also include representatives from the National Institutes of Health and the Department of Veterans Affairs, as well as consumer and patient representatives, Galson said.

The consumer and patient reps will be drawn from the pool of individuals from which FDA currently draws advisory committee members, he said.

FDA has not yet clarified whether non-FDA safety board members will be allowed to vote.

The drug safety board is one of two safety projects - the other being a Drug Watch website - HHS unveiled in February (⁵ Also see "FDA Unveils Rx Safety Board, Website; Postmarket Surveillance Overhaul Next" - Pink Sheet, 21 February, 2005., p. 4). The website has not yet launched, although seven products with prominent safety concerns are listed on CDER's main web page (see ⁶ Also see "CDER Drug Safety Website Model Includes Elidel; Novartis Objects" - Pink Sheet, 25 April, 2005.).

One of the first tasks of the drug safety board will be to establish criteria for adding or removing a drug from the website, Galson said.

A docket will be open for comment on the drug safety website listing criteria. The agency also plans to hold public meetings on the topic.

The drug safety board will also advise the CDER Director on "policy issues," such as "what is the threshold for putting a black box warning on a drug," Galson said.

Drug Safety Board Will Lead To More Advisory Cmte. Meetings – FDA’s Galson

More from Archive

More from Pink Sheet