Bush Should ‘Spurn’ Industry’s FDA Commissioner Choices

The pharmaceutical industry, having contributed $4.4 million to President Bush's campaign, is now pressing the Bush administration to select one of three "favored-son" industry insiders to head the FDA, but such a selection would be "unacceptable," according to a Los Angeles Times editorial. The three potential candidates include Searle Vice President Michael Friedman, Wyeth-Ayerst Pharmaceuticals executive Bruce Burlington and Merck Research Laboratories President Ed Scolnick, all of whom hold "high positions in the industry they would oversee," the editorial states. Noting that the FDA's 1938 charter calling for independent oversight has "already been seriously eroded," the editorial says that "an FDA chief direct from the industry could make food and drug safety even shakier." Although the FDA is "supposed to ensure" the safety and efficacy of drugs on the market, the editorial points to a two-year Times investigation by reporter David Willman that found that "drug industry pressure has led FDA regulators to rush poorly tested, potentially dangerous drugs to market even when there is no evidence of their superiority to older, safer medications." Noting that the FDA has "never fully implemented" a surveillance system to monitor the long-term side effects of fast-tracked drugs, the editorial points out that the next FDA Commissioner will be responsible for revising the entire fast-track drug approval system. In addition, the new FDA chief will be charged with implementing the Dietary Supplement Health and Education Act, which is designed to "encourag[e] the safe use of dietary supplements." Pointing out that "[n]one of the seven previous FDA commissioners have been recruited directly from the drug industry," the editorial says that the agency "clearly needs an independent leader to close gaping regulatory holes." To address these issues, the editorial says that Bush should appoint Dr. Raymond Woosley, an associate dean at Georgetown University Medical Center "who has won wide respect from health experts for his balanced view that any rapid development of drugs be tied to stronger safety review." However, the editorial states that choosing Woosley would "require some mettle" from Bush because Woosley's belief that the United States needs a "better system for tracking safety problems of FDA-approved drugs" makes the pharmaceutical industry "nervous." The editorial concludes, "The pharmaceutical companies' FDA choices represent a stark quid pro quo that Bush, for his own credibility with the American people, should spurn" (Los Angeles Times, 3/22).