F.D.A. Chief Is Named Amid Calls for More Drug Oversight
By GARDINER HARRIS and ROBERT PEAR
Published: February 15, 2005
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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
"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
Dr. McClellan left in March to become administrator of the Centers for
Medicare and Medicaid Services. Dr. Crawford again became acting
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
"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,"
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
, "The administration is under great pressure from Congress and the public
to maintain fiscal discipline and reduce the federal deficit," Dr. Crawford
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."