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09-24-2005, 09:04 AM
FDA chief quits; tenure marked by turmoil
By Diedtra Henderson, Globe Staff | September 24, 2005
WASHINGTON -- The embattled Food and Drug Administration commissioner, Lester Crawford, abruptly resigned yesterday amid accusations of lax oversight by the agency, just two months after his confirmation by the US Senate.
The resignation, effective immediately, was accepted with ''sadness" by Health and Human Services Secretary Michael Leavitt, spokeswoman Christina Pearson told the Associated Press. She would not comment on whether Crawford stepped down voluntarily.
The FDA has been hit by a series of controversies for much of Crawford's three-year tenure. Until his confirmation he had served as acting commissioner or deputy commissioner since 2002. Last month, he postponed deciding whether the FDA would allow over-the-counter sales of morning-after birth control pills, overruling staff who deemed the sales safe. The agency's chief of women's health resigned in protest over the delay.
Last year, Merck & Co. withdrew the painkiller Vioxx from the market because of safety concerns, leading to congressional hearings about FDA oversight. David Graham, an agency senior scientist, testified that reporting safety concerns was difficult and accused the agency of failing to remove dangerous drugs from the market.
The FDA was also criticized last year for a flu vaccine shortage that forced many elderly Americans to wait in long lines for shots.
In an e-mail message to staffers, Crawford said, ''It is time, at the age of 67, to step aside. I am doing so with deep gratitude to the president and both secretaries of Health and Human Services for whom I have been privileged to serve."
Dr. Andrew von Eschenbach, director of the National Cancer Institute, is expected to be named as acting FDA commissioner. Von Eschenbach, a urologic surgeon and cancer survivor, has led the institute since January 2002. Prior to that, he was executive vice president at the University of Texas M.D. Anderson Cancer Center in Houston, which he joined in 1976 as a fellow.
This week, members of Congress pressured the FDA on several fronts as the agency sought approval for its budget. Senators attached an amendment to force publication of apparent conflicts of interests among advisers who guide the FDA and called for an investigation of the agency's handling of such conflicts. Also, Senator Patty Murray, a Washington Democrat, unsuccessfully attempted to slash the FDA's budget in response to Crawford's refusal to issue a decision on the morning-after pill.
Still, his abrupt announcement stunned many.
Just weeks ago, he pledged to visit three cities, including Cambridge, to field questions from the public in a talk show-type format. The FDA canceled the first stop, citing Hurricane Katrina duties.
Crawford, who worked at the FDA four times over three decades, declined to step down as acting commissioner after his Senate confirmation was stalled by allegations he had an extramarital affair with a female staffer while he was acting commissioner. The office of the inspector general was asked in April to investigate allegations that included promoting the staffer based on the affair and failing to respond appropriately to her alleged misuse of a government credit card. The White House and Senate Republicans continued to support Crawford as the investigation continued and ultimately found that the most serious allegations were without merit.
US Senators Michael Enzi, Republican of Wyoming, and Edward M. Kennedy defended Crawford during Senate confirmation proceedings July 18 and he was confirmed on a 78-16 vote.
''Now more than ever, the nation needs a strong, independent commissioner at this vital public health agency," Kennedy said. ''I urge the president to nominate a distinguished public health leader with exceptional scientific and administrative skills to lead FDA in this critical time." Enzi's office did not respond yesterday to requests for comment.
Others used the occasion to denounce Crawford's performance.
''Lester Crawford's leadership at FDA since 2002 has been both tepid and passive," said US Senator Barbara Mikulski, Democrat of Maryland.
''Dr. Crawford's ability to lead a strong and independent FDA was in question from the start," said Murray. ''Unfortunately, during his tenure the FDA's reputation as the gold standard in public health has been tarnished."
Crawford's tenure ''was fraught with controversy, where millions of Americans were suddenly left unsure of the safety of their drugs, the availability of their flu shots, and even the trustworthiness of the agency that had been created for their protection," said US Representative Maurice Hinchey, Democrat of New York.
''What this gives is an opportunity for a strong leader to restore integrity to the agency," said Alastair Wood, associate dean of the Vanderbilt University School of Medicine.
Dr. Jerry Avorn, a Harvard Medical School professor of medicine and critic of the agency's handling of drug safety controversies, said the commissioner defines the tone and tenacity of the FDA.
''A different commissioner could take the same FDA mandate and either apply it vigorously or apply it sheepishly. So this is an opportunity for more vigor," Avorn said.
Diedtra Henderson can be reached at dhenderson@globe.com.
© Copyright 2005 Globe Newspaper (http://www.boston.com/news/nation/washington/articles/2005/09/24/fda_chief_quits_tenure_marked_by_turmoil/) Company.
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By Diedtra Henderson, Globe Staff | September 24, 2005
WASHINGTON -- The embattled Food and Drug Administration commissioner, Lester Crawford, abruptly resigned yesterday amid accusations of lax oversight by the agency, just two months after his confirmation by the US Senate.
The resignation, effective immediately, was accepted with ''sadness" by Health and Human Services Secretary Michael Leavitt, spokeswoman Christina Pearson told the Associated Press. She would not comment on whether Crawford stepped down voluntarily.
The FDA has been hit by a series of controversies for much of Crawford's three-year tenure. Until his confirmation he had served as acting commissioner or deputy commissioner since 2002. Last month, he postponed deciding whether the FDA would allow over-the-counter sales of morning-after birth control pills, overruling staff who deemed the sales safe. The agency's chief of women's health resigned in protest over the delay.
Last year, Merck & Co. withdrew the painkiller Vioxx from the market because of safety concerns, leading to congressional hearings about FDA oversight. David Graham, an agency senior scientist, testified that reporting safety concerns was difficult and accused the agency of failing to remove dangerous drugs from the market.
The FDA was also criticized last year for a flu vaccine shortage that forced many elderly Americans to wait in long lines for shots.
In an e-mail message to staffers, Crawford said, ''It is time, at the age of 67, to step aside. I am doing so with deep gratitude to the president and both secretaries of Health and Human Services for whom I have been privileged to serve."
Dr. Andrew von Eschenbach, director of the National Cancer Institute, is expected to be named as acting FDA commissioner. Von Eschenbach, a urologic surgeon and cancer survivor, has led the institute since January 2002. Prior to that, he was executive vice president at the University of Texas M.D. Anderson Cancer Center in Houston, which he joined in 1976 as a fellow.
This week, members of Congress pressured the FDA on several fronts as the agency sought approval for its budget. Senators attached an amendment to force publication of apparent conflicts of interests among advisers who guide the FDA and called for an investigation of the agency's handling of such conflicts. Also, Senator Patty Murray, a Washington Democrat, unsuccessfully attempted to slash the FDA's budget in response to Crawford's refusal to issue a decision on the morning-after pill.
Still, his abrupt announcement stunned many.
Just weeks ago, he pledged to visit three cities, including Cambridge, to field questions from the public in a talk show-type format. The FDA canceled the first stop, citing Hurricane Katrina duties.
Crawford, who worked at the FDA four times over three decades, declined to step down as acting commissioner after his Senate confirmation was stalled by allegations he had an extramarital affair with a female staffer while he was acting commissioner. The office of the inspector general was asked in April to investigate allegations that included promoting the staffer based on the affair and failing to respond appropriately to her alleged misuse of a government credit card. The White House and Senate Republicans continued to support Crawford as the investigation continued and ultimately found that the most serious allegations were without merit.
US Senators Michael Enzi, Republican of Wyoming, and Edward M. Kennedy defended Crawford during Senate confirmation proceedings July 18 and he was confirmed on a 78-16 vote.
''Now more than ever, the nation needs a strong, independent commissioner at this vital public health agency," Kennedy said. ''I urge the president to nominate a distinguished public health leader with exceptional scientific and administrative skills to lead FDA in this critical time." Enzi's office did not respond yesterday to requests for comment.
Others used the occasion to denounce Crawford's performance.
''Lester Crawford's leadership at FDA since 2002 has been both tepid and passive," said US Senator Barbara Mikulski, Democrat of Maryland.
''Dr. Crawford's ability to lead a strong and independent FDA was in question from the start," said Murray. ''Unfortunately, during his tenure the FDA's reputation as the gold standard in public health has been tarnished."
Crawford's tenure ''was fraught with controversy, where millions of Americans were suddenly left unsure of the safety of their drugs, the availability of their flu shots, and even the trustworthiness of the agency that had been created for their protection," said US Representative Maurice Hinchey, Democrat of New York.
''What this gives is an opportunity for a strong leader to restore integrity to the agency," said Alastair Wood, associate dean of the Vanderbilt University School of Medicine.
Dr. Jerry Avorn, a Harvard Medical School professor of medicine and critic of the agency's handling of drug safety controversies, said the commissioner defines the tone and tenacity of the FDA.
''A different commissioner could take the same FDA mandate and either apply it vigorously or apply it sheepishly. So this is an opportunity for more vigor," Avorn said.
Diedtra Henderson can be reached at dhenderson@globe.com.
© Copyright 2005 Globe Newspaper (http://www.boston.com/news/nation/washington/articles/2005/09/24/fda_chief_quits_tenure_marked_by_turmoil/) Company.
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