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FDA's Crawford Resigns as Top U.S. Drug Regulator (Update2)

FDA's Crawford Resigns as Top U.S. Drug Regulator

Sept. 23 (Bloomberg) -- Lester Crawford resigned as chief of the U.S. Food and Drug Administration after three years of controversies over drug safety, animal feed regulation and charges he delayed the morning-after contraceptive for political reasons.

Crawford, a veterinarian who wasn't confirmed as permanent FDA commissioner until July, said in a memo to the agency staff that ``it is time at the age of 67 to step aside.'' He declined through FDA spokeswoman Julie Zawisza to be interviewed. Crawford served as acting or deputy FDA commissioner since February 2002.

``We will not be missing him,'' said Peter Lurie, director of health research at the consumer advocacy group Public Citizen, in a telephone interview today. ``Many of the most serious drug disasters of the last several decades occurred on his watch. He was too much in the pocket of industry.''

Congressional committees in the past year probed the FDA's monitoring of drug safety after antidepressants were linked to increased suicide risks and Merck & Co. withdrew the Vioxx painkiller because of heart attack risks. Crawford testified last November on a shortage of influenza vaccine, and his confirmation was delayed by two senators until he agreed to make a decision on Barr Pharmaceuticals Inc.'s Plan B morning-after contraceptive.

President George W. Bush plans to name Andrew von Eschenbach, director of the National Cancer Institute, to be acting FDA commissioner, the White House said in a statement today. The institute's press office declined to comment or respond to a request to interview von Eschenbach.

Second Resignation

Von Eschenbach was appointed to lead the National Cancer Institute in January 2002 after 25 years at the University of Texas M.D. Anderson Cancer Center in Houston, according to his biography on the institute's Web site. He received his medical degree from Georgetown University in 1967.

Crawford is the second Bush administration appointee to resign this month. Federal Emergency Management Agency director Michael Brown, 50, stepped down Sept. 12, three days after being ousted from the Hurricane Katrina relief effort because of protests over his handling of the worst U.S. natural disaster.

The FDA was criticized by Congress's Government Accountability Office for failing to properly enforce a 1997 ban on feeding ground-up cattle back to cattle, so-called ``ruminant to ruminant'' feeding. The practice is considered the prime culprit in the spread of mad cow disease, which has a fatal human variant. The FDA has been considering tightening the rules since 2002. Crawford this week told a Washington panel that new feed rules would be out ``within days.''

Grassley Comments

The former FDA chief has ``been criticized by some in Congress for lack of leadership on drug-safety issues that were given an extensive airing'' after the Vioxx withdrawal, said analyst Ira Loss of Washington Analysis, which advises investors on policy, in a note to clients. Loss has followed health policy in Washington for three decades. He declined to comment further.

Senate Finance Committee Chairman Charles Grassley, an Iowa Republican who held hearings on the FDA's monitoring of drug safety, said the chance to name a new commissioner is an opportunity to make changes in the way the agency operates.

``In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information,'' he said in a statement today. ``Now is the time to reform the FDA's culture and reassert that the agency's top priority is what's good for John Q. Public when it comes to reviewing drugs in the marketplace and making new miracle medicines available.''

Women's Health

Pharmaceutical Research and Manufacturers of America, the main U.S. industry group of drugmakers, declined to immediately comment, spokesman Jeff Trewhitt said.

``We'd rather have somebody strong on the science who is politically defensible,'' said Miller Tabak & Co. health-care strategist Les Funtleyder in a telephone interview from New York. ``This way he understands the process.''

Bush nominated Crawford as permanent FDA chief in February. His confirmation also was delayed for an investigation into allegations that Crawford had an affair with an employee and promoted her on that basis. The Health and Human Services Department's Office of the Inspector General in June released a letter saying its probe found no evidence of an affair or the alleged favoritism.

``Women's health suffered under Dr. Crawford's tenure,'' said Karen Pearl, the interim president of Planned Parenthood Federation of America, in a statement today. ``The FDA has become a politicized agency and has ignored its mandate to safeguard the public health.''

Clinton, Murray

Two Democratic Senators, Patty Murray of Washington and Hillary Clinton of New York, blocked Crawford's nomination until Health and Human Services Secretary Michael Leavitt said the FDA would decide on Barr's Plan B application by Sept. 1. The agency said Aug. 26 that it would delay a decision to gather public comments. Susan F. Wood, the top U.S. regulator for women's health, resigned Aug. 31 over the postponement.

``With the resignation of Dr. Crawford, the FDA has a real opportunity to restore its battered reputation and nominate a leader with vision and drive to ensure that the FDA upholds its gold standard of drug regulation,'' Clinton said today in an e- mailed statement.

Crawford, from Demopolis, Alabama, holds a doctorate in pharmacology from the University of Georgia in Athens, Georgia.

To contact the reporters on this story:
Nicole Ostrow in New York at [e-mail];
Geraldine Ryerson-Cruz in Washington at [e-mail].


LINK: http://www.bloomberg.com/apps/news?pid=10000103&sid=aQBKIAvNJpXM&refer=us