Top FDA guy resigns - impact on industry?

[Wes Bucey]

FWIW, this story came across the wires once the weekend doldrums hit. I wonder how the resignation and his subsequent replacement will affect the industry.

FDA Commissioner Lester Crawford Resigns
Sep 23, 6:43 PM (ET)
By LAURAN NEERGAARD
WASHINGTON (AP) - Embattled Food and Drug Administration Commissioner Lester Crawford abruptly resigned Friday, telling his staff that at age 67 it was time to step aside.

President Bush designated the National Cancer Institute's director, Dr. Andrew von Eschenbach, to be the FDA's new acting commissioner.
Crawford's resignation came just two months after the Senate, in a long-delayed move, elevated the longtime agency deputy and acting commissioner to the top job.

His three-year tenure at FDA was marked by increasing criticism and a particularly rocky final 12 months. The painkiller Vioxx was pulled off the market for safety problems, FDA was embarrassed last fall when its British counterparts shut down a supplier of U.S. flu vaccine for tainted shots, and over the summer recalls of malfunctioning heart devices mounted.

Finally last month, morale at the agency plummeted when Crawford indefinitely postponed nonprescription sales of emergency contraception over the objections of staff scientists who had declared the pill safe. FDA's women's health chief resigned in protest.

Still, Crawford's resignation, effective immediately, was a surprise. An affable veterinarian who specialized in food safety, he was elevated by President Bush from acting commissioner to the full job in part because his experience was deemed important as the FDA tried to better safeguard the food supply against bioterrorism. Crawford gave a speech Monday in Washington during which he betrayed no sign he was planning to leave, instead discussing upcoming FDA policy on the safety of cloned beef.

Health and Human Services Secretary Mike Leavitt accepted Crawford's resignation "with sadness," said department spokeswoman Christina Pearson. "We thank him for his service and wish him well."

Asked if he was forced to resign, Pearson said she couldn't comment further on a personnel issue.

Von Eschenbach, tapped to be the FDA's acting chief, is a cancer survivor and urologic surgeon from Bush's home state who was chief academic officer of the University of Texas M.D. Anderson Cancer Center before moving to the National Cancer Institute.

His tenure isn't immune from controversy either: Von Eschenbach has said that he hopes by 2015 to make cancer a chronic disease that patients can live with instead of die from. While a laudable goal, it's one that many oncologists caution that science isn't yet that close to achieving for most types of cancer.

Women's groups welcomed Crawford's departure with the hope that the agency would immediately revisit emergency contraception, and lawmakers called for a strong replacement.

"Lester Crawford's leadership at FDA since 2002 has been both tepid and passive," said Sen. Barbara Mikulski, D-Md., whose state is home to FDA's suburban Washington headquarters. She called the resignation "a move toward reforming FDA."

"In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information," said Sen. Charles Grassley, R-Iowa, who has spent 18 months investigating the agency. "The opportunity to name a new commissioner is a chance to take the agency in a necessary new direction ... 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."

But one consumer group lamented Crawford's departure, particularly the loss of his food-safety expertise.

"The agency has had so much turnover in the top spot, and turmoil throughout, that it could have benefited from a period of steady leadership," said Michael Jacobson of the Center for Science in the Public Interest. "The country doesn't need a rudderless FDA."

Crawford, who had worked at the FDA on four occasions over 30 years, as well as the Agriculture Department and as an adviser to the World Health Organization, cited among his accomplishments new steps to improve drug safety and speed drug development, and bringing more funding to the cash-strapped agency through manufacturer-paid fees.

"I also must thank the extraordinary people of FDA for the honor of having served with them," Crawford wrote in a memo to his staff Friday. "They have made public service a joy and a pleasure as we worked together to accomplish great things for public health."

[Marc]

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