Crawford Confirmed as FDA Chief

Crawford: FDA’s new boss.

In July, following a contentious hearing process, the U.S. Senate finally confirmed Lester M. Crawford, DVM, PhD, as permanent FDA commissioner. President Bush nominated Crawford to the top spot at the agency in March, but the confirmation was delayed for five months by a bipartisan group of congressional critics who questioned Crawford’s leadership on a number of issues, including drug safety and approval, policy enforcement, agency staffing, and fiscal management.

Crawford came under fire for FDA’s allegedly slow response to drug-safety issues involving antiarthritis Cox-2 inhibitors such as Vioxx and Celebrex, antidepressants prescribed for children, and dietary supplements like ephedra.

Upset with the agency’s failure to approve over-the-counter status for Plan B—the so-called “morning after” emergency contraceptive drug—Senators Hillary Rodham Clinton (D–NY) and Patty Murray (D–WA) put a hold on the nomination, in effect preventing the confirmation process from moving forward. The hold was lifted only after the senators received assurances from Michael Leavitt, secretary of the Department of Health and Human Services, that FDA will rule on whether to grant over-the-counter status to Plan B by September 1.

Murray: Independence, not appeasement.

Approval of Plan B was recommended by an FDA advisory panel in a 24–3 vote, but was later rejected by FDA, which cited potential health concerns for women 16 and under. The manufacturer has since resubmitted its application with revised guidelines. Citing the need for “an independent FDA,” Senator Murray suggested that the agency’s ruling against Plan B was largely based on the administration’s need to “appease its conservative base.”

Other senators with holds on the nomination included Tom Coburn (R–OK) and David Vitter (R–LA). Coburn was concerned about the need for better use and safety information on condom labeling while Vitter sought support for his bill that would allow importation of drugs from other countries.

Grassley: Demanding visionary leadership.

The most vocal critic of the nominee was senate finance committee chair Charles Grassley (R–IA), who questioned Crawford’s performance at the agency with regard to both regulatory policy enforcement and personnel management. Citing a need for structural changes at the agency, Grassley said that “Crawford has not stepped up to the plate. I have seen no recognition of the depth and breadth of the problems at FDA. I have only seen a few short-term Band-Aids. The evidence is overwhelming that FDA must change to better protect the American people. Unfortunately, the systemic problems at FDA demand visionary leadership. Dr. Crawford has not shown me he is the leader to fix FDA.”

On the fiscal front, Grassley challenged Crawford’s handling of travel expenses and bonuses paid to senior FDA officials, which increased from $160,000 a year when Mark B. McClellan, MD, PhD, was commissioner to more than $500,000 in the past year under Crawford.

Kennedy: Key support.

Crawford received key support from Senator Edward Kennedy (D–MA), who said, “Crawford is well qualified to be commissioner. He deserves to have full authority as commissioner.”

The Senate vote in favor of the nomination was 78–16.

Following Crawford’s confirmation, Senator Mike Enzi (R–WY), chair of the senate health, education, labor and pensions committee, said, “While I respected the right of my colleagues to disagree with a president’s choice, in the end, I believe we have made the right decision to promote Dr. Crawford. He has a long and distinguished history of leadership and public service, and I look forward to his continued work in promoting and protecting the public health.”

Industry response to Crawford’s confirmation as FDA chief was quite positive.

James C. Greenwood, president and CEO of the Biotechnology Industry Organization (BIO; Washington, DC), cited the emerging “era of personalized medicine” and the need for “Dr. Crawford’s leadership and a well-funded, effectively managed FDA to bring these scientific breakthroughs to patients.”

Commenting on the confirmation, Stephen J. Ubl, president and CEO of industry association AdvaMed (Washington, DC), said that the organization “is pleased that this vital agency has a permanent leader and looks forward to continuing to work with Dr. Crawford. He has a great familiarity with many of the key issues that affect medical technology companies and understands the unique characteristics of our industry.”

MDMA’s Leahey: An eye on innovation.

Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC), hailed Crawford’s “experience and leadership, which will allow him to deal with the challenges associated with the rapid innovation in the medical technology industry. MDMA looks forward to continuing to work with Dr. Crawford on a variety of issues important to patients and innovators.”

Crawford, 67, is a veterinarian and food-safety expert with a doctorate in pharmacology. He has held the title of acting FDA commissioner since March 2004 when the former head of the agency, Mark McClellan, left to head up the Centers for Medicare and Medicaid Services (CMS; Baltimore). Crawford was named deputy commissioner in February 2002 and also served as acting commissioner prior to McClellan’s appointment in November 2002.

According to its mission statement, FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation. With an annual budget of $1.88 billion and more than 9000 employees located in 167 cities across the United States, the agency monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of goods annually.

Canon Communications LLC

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