President Bush To Name Acting FDA Commissioner Lester Crawford as Permanent Agency Head
President Bush on Monday announced that he would nominate FDA Acting Commissioner Lester Crawford as the permanent head of the agency, "despite drug safety problems on Crawford's watch that have undermined the agency's reputation and credibility," the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 2/15).
Crawford has served as acting commissioner or deputy commissioner of the agency for the past three years. FDA has had a permanent commissioner for about one-third of Bush's presidency, the Washington Post reports (Kaufman, Washington Post, 2/15). Bush in 2001 considered Crawford for the post before nominating current CMS administrator Mark McClellan. According to the New York Times,
Crawford, who has been acting commissioner since taking over for McClellan last March, "has made priorities of speeding crucial drug approvals, protecting drugs and food from terrorist attacks, and improving the manufacture and safety of medicines." Crawford has stated he opposes legalizing the reimportation of prescription drugs from foreign nations.
The appointment must be confirmed by the Senate, and congressional aides said Crawford probably will be confirmed, "but only after a rigorous review of the agency's performance," the New York Times reports (Harris/Pear, New York Times, 2/15).
According to CQ Today, lawmakers from both parties on Monday "urg[ed] a thorough confirmation process" for Crawford. Several senators indicated "they want specifics ... about his role in the agency's current crises and how he plans to restore the FDA's damaged public image," CQ Today reports (Carey, CQ Today, 2/14).
Crawford's nomination came "just before a widely anticipated" meeting of FDA advisory committees on the safety of COX-2 medications, the New York Times reports (New York Times, 2/15).
Members of the FDA arthritis and drug safety and risk management advisory committees on Wednesday will begin a three-day meeting to determine whether to remove COX-2 inhibitors from the market over safety concerns. The members of the advisory committees will review hundreds of documents from FDA scientists and the manufacturers of COX-2 inhibitors and hear testimony from scientists, physicians and patients (California Healthline, 2/14).
Kenneth Kaitin, head of the Tufts Center for the Study of Drug Development, said, "It's very important for the agency to have a commissioner when there is a public debate over the FDA, the drug review process and the safety of the drug supply" (Boston Herald, 2/15).
According to the Wall Street Journal, the administration "is taking a safe line" with Crawford, by "selecting a seasoned official without strong ties to drug companies" (Wilde Mathews, Wall Street Journal, 2/15). The Los Angeles Times reports that Bush's choice, which "disappointed those who had hoped for a blue-ribbon nominee who might bring dramatic reforms," essentially sent a signal that the president believes nothing is "fundamentally wrong at FDA" (Los Angeles Times, 2/15).
According to the New York Times, lawmakers have recently "demand[ed] that the administration nominate a commissioner soon," but the White House "showed little interest in the task before last year's election and had other priorities after it, leading to predictions that Crawford would be the selection by default" (New York Times, 2/15). Crawford, a veterinarian, has a doctorate in pharmacology and is considered an expert on food safety, which HHS has said it plans to focus on in the coming years (Washington Post, 2/15).
HHS Secretary Mike Leavitt said in a statement that Crawford is an "outstanding choice," who will "lead the way as we enter a new era of individualized medicine and rapidly developing science" (Wall Street Journal, 2/15). Leavitt added, "With Crawford's leadership, FDA will provide the world's safest drugs and empower citizens with the tools they need to make informed choices about their health" (Heldt Powell, Boston Herald, 2/15).
An unnamed administration official said, "I think the FDA has gotten a bum rap, and some people may be trying to transfer that bum rap to Crawford," adding, "If we went outside to find someone new or different, that person would not have the length and breadth of experience [Crawford] has" (Los Angeles Times, 2/15).
Crawford said, "The administration is under great pressure from Congress and the public to maintain fiscal discipline and reduce the federal deficit," adding that Bush's fiscal year 2006 budget proposal, which would give a 4.4% increase in funding to FDA, shows the White House recognizes the "need for adequate resources."
However, Crawford said, "FDA must leverage its resources through increased cooperation and collaboration with stakeholders" (New York Times, 2/15).
The Pharmaceutical Research and Manufacturers of America released a statement praising Crawford as a man who "responds to concerns and crises quickly and with quiet efficiency."
Biotechnology Industry Association President James Greenwood said Crawford has done a "remarkable job" as acting commissioner, adding, "This nomination sends the right signal to patients and consumers, that there will be vision and leadership in the agency" (Washington Post, 2/15).
Sen. Judd Gregg (R-N.H.) said, "FDA regrettably has had a very challenging year and needs permanent leadership" (New York Times, 2/15). Gregg added, "I have great respect for Lester Crawford and believe he is the right choice for the job" (CQ Today, 2/14).
According to the Post, some individuals said "they were concerned about [FDA's] slow response to recent safety concerns about Vioxx and other COX-2 inhibitors, widespread prescribing of antidepressants to children and the dietary supplements such as ephedra."
Critics also said that under Crawford, FDA has made decisions "that appeared to be based on politics rather than science," including a decision last year to reject over-the-counter sales of the emergency contraceptive Plan B, the Post reports (Washington Post, 2/15). Crawford also has been criticized for his response to the flu vaccine shortage (New York Times, 2/15).
"In some cases, the FDA has disregarded important concerns and warnings from its own best scientists," Sen. Chuck Grassley (R-Iowa) said, adding, "During Senate consideration of Crawford's nomination, I want to hear statements that prove he understands why public confidence has been shaken and a commitment to enacting reforms inside the FDA to keep the agency focused on public health and safety" (Washington Post, 2/15). Grassley added, "We've seen evidence over the last year that the agency has become too cozy with drug companies" (CQ Today, 2/14).
Sen. Edward Kennedy (D-Mass.) "voiced reservations" about Crawford but indicated "he was pleased that the agency was getting a permanent commissioner," the Post reports (Washington Post, 2/15). "As many of these [drug safety] controversies arose while Crawford was acting commissioner, it will be important for him to lay out to Congress and the America public his specific plans to ensure the safety of our prescription drugs as well as our food supply," Kennedy said (Boston Herald, 2/15).
Janell Mayo Duncan, legislative and regulatory counsel for Consumers Union, said, "Under Crawford's watch, FDA has failed to protect the public from dangerous prescription drugs, dietary supplements and contaminated animal feed that could carry mad cow disease" (New York Times, 2/15).
Brian Strom, a pharmaceutical expert at the University of Pennsylvania, said, "If [Bush] was going to take a person from the inside, one would have thought he would have done it a long time ago. It just seems funny to leave somebody as interim for such a long time."
Michael Jacobson, executive director of the Center for Science in the Public Interest, said, "The administration could have brought in somebody with a reputation as a tough-minded reformer whose top priority is public health, but instead they are appointing somebody who has been a bureaucrat in the agency and who does not have a strong record of calling for needed reforms" (Los Angeles Times, 2/15).