FDA's Graham, Sen. Grassley Criticize New Drug Safety Panel

Main Category: Public Health
Article Date: 14 Jun 2005 - 2:00 PDT

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The new FDA Drug Safety Oversight Board will not increase the ability of the agency to remove unsafe prescription drugs from the market and could impede efforts to make medications safer, according to FDA safety officer David Graham and... Senate Finance Committee Chair Chuck Grassley (R-Iowa), the Washington Post reports. Graham criticized the structure of the board, which he called "severely biased in favor of industry," and said that "FDA cannot be trusted to protect the public or reform itself." In a letter to acting FDA Commissioner Lester Crawford, Grassley wrote that senior managers from the FDA Center for Drug Evaluation and Research, the office that is responsible for the review and approval of new medications, will hold 11 of the 15 voting positions on the board. Graham and Grassley maintain that those individuals likely will focus more on the potential benefits than the safety of new prescription drugs and tend not to withdraw from the market medications that they approved. Grassley wrote, "What we have here is nothing more than the status quo," adding, "Where are the people responsible for post-marketing surveillance who have allegiances only to post-marketing safety and the public's well-being, and not to the drugs that they helped put on the market in the first place?" Graham and Grassley also criticized the decision by FDA to make board deliberations private. According to Grassley, "the agency should be making every effort to improve transparency and accountability." Graham said, "Ironically, drug safety in the U.S. is worse off today than it was in November," when he testified in a Senate Finance Committee hearing about concerns related to the decision by Merck last September to withdraw the COX-2 inhibitor Vioxx from the market.

Response
Acting FDA Deputy Commissioner for Operations Janet Woodcock declined to respond to the comments by Graham and Grassley, but she defended the board, which she said "will be able to meet quickly, deliberate and make some strong recommendations if needed." Woodcock added, "They will be moving issues up and down the scale of urgency." She also said that voting members of the board will not include FDA staff involved with individual medication approvals and only a few of their supervisors (Kaufman, Washington Post, 6/8).

Committee To Examine FDA Rx Drug Safety Practices
In related news, a National Academy of Sciences committee organized by the Institute of Medicine on Wednesday will hold the first of three meetings to examine problems related to public confidence in FDA and the safety of prescription drugs. The committee will examine the practices used by FDA to monitor the safety of medications after they reach the market. FDA last year requested the IOM examination (Nesmith, Atlanta Journal-Constitution, 6/8).

Broadcast Coverage
NPR's "Morning Edition" on Wednesday reported on criticism of the drug safety panel. The segment includes comments from Alan Goldhammer, associate vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America; Woodcock; and Raymond Woosley, president of the Critical Path Institute, a not-for-profit organization created to facilitate innovations in drug development (Silberner, "Morning Edition," NPR, 6/8).

The complete segment is available online in RealPlayer.

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