FDA's proposal for greater "independence" of its drug safety reviews is the creation of an Administration-wide oversight board.

HHS Secretary Leavitt announced the creation of the FDA Drug Safety Oversight Board Feb. 15 in a meeting with FDA employees.

FDA launched a drug safety initiative in November. The plan includes an ongoing review of drug safety in the U.S. by the Institute of Medicine (¹ Also see "FDA Drug Safety Review Will Consider Pros And Cons Of Separate Safety Agency" - Pink Sheet, 5 November, 2004.).

The drug safety board will comprise "members from FDA as well as medical experts from other HHS agencies and government departments," HHS said.

The only other agency specifically named by HHS was the Department of Veterans Affairs, which has extensive experience with pharmaceutical management.

FDA's proposal addresses the main theme of upcoming Congressional hearings slated to examine how independent FDA's drug safety reviews are from the agency's new drug approval process (² Also see "Senate Drug Safety Hearings Will Take Broad View Of FDA Process" - Pink Sheet, 9 February, 2005.).

The proposal essentially creates a higher level of drug safety review within the agency without relinquishing any control of the oversight to an external body.

An FDA "fact sheet" on the Drug Safety Board notes that members of the oversight panel will be appointed by the FDA commissioner.

The primary function of the Drug Safety Board will be the oversight and management of FDA's new drug safety website, Drug Watch (³ Also see "“Drug Watch” Website Included In FDA’s Rx Safety Reforms" - Pink Sheet, 15 February, 2005.).

The oversight panel will also be charged with "resolving disagreements over approaches to drug safety issues, assessing the need for MedGuides and overseeing development and implementation of Center-wide drug safety policies."

HHS noted in its press release that its proposal is intended to improve drug safety "oversight," through the establishment of the Drug Safety Board, and "openness," through the creation of the Drug Watch website.

FDA has not yet publicly unveiled any further details about the Drug Safety Board's membership or when and how frequently the panel will meet.

The agency's drug safety website promises to have more information available to the public by Feb. 23.

From FDA's perspective, the most important deadline related to the Drug Safety Board may have been to have announced its creation on the eve of the Arthritis Drugs and the Drug Safety & Risk Management Advisory Committees' joint review of the COX-2 inhibitor class.

The announcement also came one day after President Bush formally disclosed his intent to nominate FDA acting Commissioner Lester Crawford as commissioner (⁴ Also see "It's Official: Crawford Is White House Nominee For FDA" - Pink Sheet, 14 February, 2005.).

- Steele Thomas

FDA Drug Safety Oversight Board Will Include VA, Other Agencies

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