F.D.A. Chief Is Named Amid Calls for More Drug Oversight

Published: February 15, 2005
http://www.nytimes.com/2005/02/15/politics/15fda.html?th  (must register to view original article)

WASHINGTON, Feb. 14 - President Bush announced on Monday that he would nominate the acting commissioner of the Food and Drug Administration, Dr. Lester M. Crawford, as the permanent head of the agency.

The move comes amid a Congressional investigation of the agency and widespread calls that it strengthen oversight of drug safety.

Dr. Crawford, whom Mr. Bush considered and rejected for the post in 2001, has made priorities of speeding crucial drug approvals, protecting drugs and food from terrorist attacks, and improving the manufacture and safety of medicines. He has opposed legalizing drug imports.

Health and Human Services Secretary Michael O. Leavitt is expected to visit the agency office in Rockville, Md., on Tuesday not only to praise Dr. Crawford but also to announce new efforts to improve detection of unknown dangers of drugs.

Mr. Leavitt called Dr. Crawford an outstanding choice who "has dedicated his career to advancing the nation's public health."

The post has been vacant since last March, when Dr. Mark B. McClellan left to become the Medicare chief. The nomination was announced just before a widely anticipated three-day meeting of a drug-advisory committee that starts on Wednesday. The panel is to examine, in part, how the agency handled questions on the safety of huge-selling pain pills like Vioxx, Celebrex and Bextra.

Calls in Congress have grown louder for significant changes at the agency. Its problems led members of Congress to demand that the administration nominate a commissioner soon. But finding a well-respected physician or researcher who has not worked recently for the drug industry or has not acted or spoken without raising political issues has proved difficult. The administration showed little interest in the task before last year's election and had other priorities after it, leading to predictions that Dr. Crawford would be the selection by default.

Reactions to the nomination were mixed. Republicans and even some Democrats on Capitol Hill welcomed it. Industry groups expressed support. Some consumer advocates announced opposition.

"Under Dr. Crawford's watch, the F.D.A. has failed to protect the public from dangerous prescription drugs, dietary supplements and contaminated animal feed that could carry mad cow disease," said Janell Mayo Duncan, legislative and regulatory counsel for Consumers Union.

Not all consumer groups agreed. "He's not my ideal candidate, but the devil you know is better than the one you don't," said Dr. Michael F. Jacobson, executive director of the Center for Science in the Public Interest, a frequent critic of the government and the food industry.

Senator Judd Gregg, the New Hampshire Republican who is chairman of the Senate Budget Committee, said, "The F.D.A. regrettably has had a very challenging year and needs permanent leadership."

Senator Edward M. Kennedy, the Massachusetts Democrat whose opposition could have proved troublesome, said, "Dr. Crawford has had a long association with the F.D.A. and is intimately familiar with the issues facing the agency."

Representative Henry A. Waxman, Democrat of California, said, "The F.D.A. has been a troubled agency during Dr. Crawford's leadership."

A spokesman for the Pharmaceutical Research and Manufacturers of America, Jeff Trewhitt, said the drug industry was eager to end the uncertainty at the agency.

"He is well aware of the need for good management and sound science in executing F.D.A. regulations," Mr. Trewhitt said of Dr. Crawford.

Congressional aides said they believed that Dr. Crawford would be confirmed but only after a rigorous review of the agency's performance.

Tommy G. Thompson, the former health and human services secretary, tapped Dr. Crawford in 2001 as his choice for commissioner. Mr. Bush blocked the appointment. Instead, Dr. Crawford became deputy commissioner and was acting commissioner for nine months until Mr. Bush appointed Dr. McClellan to head the agency.

Dr. McClellan left in March to become administrator of the Centers for Medicare and Medicaid Services. Dr. Crawford again became acting commissioner.

An affable man from Demopolis, Ala., Dr. Crawford earned a doctorate of veterinary medicine from Auburn University and a doctorate in pharmacology from the University of Georgia. He became head of the Center for Veterinary Medicine at the food and drug agency in 1978, returned to Georgia in 1980 and came back to the agency in 1982.

He left again in 1985 and worked for the food industry, among other positions, before returning in 2002.

Dr. Crawford's leadership has come under fierce criticism. When British health authorities condemned more than 40 million doses of flu vaccine from a plant in England and left the United States critically short of the medicine, Dr. Crawford said he was shocked by the news, a comment that led some critics to ask why his agency was surprised by problems that its inspectors had identified.

The agency was slow to acknowledge that antidepressants can cause depressed children and teenagers to be suicidal, even though one of its top safety officials was the first to confirm the link. And when Merck withdrew Vioxx in September because of data showing that it hurt the heart, the agency was criticized for failing to warn more strongly about the drug's dangers years earlier.

"This is disappointing news because it was on Dr. Crawford's watch that many of the worst recent crises in drug safety have occurred," said Dr. Jerome L. Avorn, a professor of medicine at Harvard.

Fierce criticism came from abortion rights groups, angry that top agency officials overruled drug reviewers last year and refused to approve over-the-counter sales of Plan B, a prescription emergency contraceptive. The groups said the agency was ignoring science and making the decision on political grounds. An official denied that.

"By rewarding Mr. Crawford for buckling under political pressure, President Bush is showing his true colors once again," said Nancy Keenan, president of Naral Pro-Choice America, an abortion rights group. "In this administration, keeping far-right activists happy is the most important thing."

Senator Charles E. Grassley, the Iowa Republican who is investigating the agency, said he looked forward to questioning Dr. Crawford at his confirmation hearing. "I want to hear statements that prove he understands why public confidence has been shaken and a commitment to enacting reforms inside the F.D.A. to keep the agency focused on public health and safety," he said.

Mr. Leavitt's announcement on Tuesday is widely expected to highlight money in Mr. Bush's budget to add experts to review drug safety and to publicize the risks of some drugs. The effort includes documenting injuries and other adverse effects of drugs already on the market.

The budget for 2006 seeks an increase of $6.5 million, or 24 percent, for the Office of Drug Safety to add 25 workers, making its total 134.

Officials at the agency said they would use some of the added money to gain access to a wide variety of databases established by health insurers and pharmacies. The agency said it would use the information to monitor drug safety by detecting "adverse events" and medication errors.

Over all, Mr. Bush is seeking $1.88 billion for the Food and Drug Administration in 2006, an increase of $81 million, or 4.4 percent, over 2005.

, "The administration is under great pressure from Congress and the public to maintain fiscal discipline and reduce the federal deficit," Dr. Crawford said.

The White House recognizes the "need for adequate resources," he said, but the "F.D.A. must leverage its resources through increased cooperation and collaboration with stakeholders."