Crawford Senate Confirmation Hearing To Focus on Tenure as Acting FDA Commissioner

Members of the Senate Health, Education, Labor and Pensions Committee on Thursday during a confirmation hearing for Lester Crawford, the nominee for FDA commissioner, likely will focus on his tenure as acting agency commissioner at a time when FDA "was plagued by drug safety problems," CQ HealthBeat reports (CQ HealthBeat, 3/16). Crawford has served as acting commissioner or deputy commissioner of FDA for the past three years. President Bush in 2001 considered Crawford for the position of FDA commissioner before he nominated Mark McClellan, who currently is the CMS administrator.

Crawford, who has served as acting FDA commissioner since McClellan left the position last March, has focus on expedited approvals of new medications, protection of the U.S. food and prescription drug supply from terrorist attacks and improvement of prescription drug manufacturing and safety. Crawford has said that he opposes the legalization of prescription drug reimportation from other nations (California Healthline, 2/15).

According to CQ HealthBeat, the most "significant questions" at the hearing likely will focus on how FDA addressed safety issues related to COX-2 inhibitors, reports that antidepressants could increase the incidence of suicidal thoughts in children and an unexpected flu vaccine shortage last year. Committee Democrats also likely will ask questions related to prescription drug reimportation, CQ HealthBeat reports (CQ HealthBeat, 3/16).

Republicans support confirmation for Crawford as FDA commissioner, but some Democrats and consumer advocates are "questioning President Bush's choice," the AP/Las Vegas Sun reports (Freking, AP/Las Vegas Sun, 3/16). A spokesperson for Sen. Edward Kennedy (D-Mass.) said that the ability of FDA to protect the health and safety of U.S. residents "has been called into question in recent years," adding, "We have a responsibility to seriously examine issues such as drug safety and give Dr. Crawford the opportunity to provide explanations" (CQ HealthBeat, 3/16).

Consumers Union, the Consumer Federation of America and the U.S. Public Interest Research Group have questioned whether Crawford has the "willingness to act in the best interest of consumers" (AP/Las Vegas Sun, 3/16).

Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "Crawford has been and will be one of the worst commissioners that there has been." However, according to the New York Times, Crawford has "guided the agency through one of its most difficult periods in decades" and likely will receive many "'it-could-have-been-worse' endorsements" (Harris, New York Times, 3/16).

Senate Majority Leader Bill Frist (R-Tenn.) said, "Dr. Crawford's eminently qualified to handle the challenges and responsibilities of keeping our nation's food and drug supply safe and secure." Jeff Trewhitt -- a spokesperson for the Pharmaceutical Research and Manufacturers of America, which supports confirmation for Crawford -- added, "Crawford knows the agency, and he knows it well. He responds to crises quickly and with quiet efficiency." (AP/Las Vegas Sun, 3/16).

NPR's "Morning Edition" on Thursday reported on the confirmation hearing for Crawford. The segment includes comments from Crawford; Wolfe; and Dr. Raymond Woosley, director of the University of Arizona C-Path Institute, which works with FDA to expedite prescription drug development and approval (Silberner, "Morning Edition," NPR, 5/17). The complete segment is available online in RealPlayer.