FDA Chief Gets New Post but Is Seen as Scapegoat

Dr. Frank E. Young is stepping down as commissioner of the beleaguered Food and Drug Administration, which has been under widespread and increasing fire in recent years from lawmakers, consumer groups, AIDS activists and others.

Capitol Hill and agency sources said that Young did not want to leave his job and had been made a scapegoat for agency problems.

Young will leave the FDA on Dec. 18 to become deputy assistant secretary for health/science and environment at the Department of Health and Human Services. He will report to Dr. James O. Mason, assistant secretary for health.

HHS Secretary Louis W. Sullivan, in a statement, called Young a “man of great intelligence, energy and dedication” whose “scientific credentials are impressive.”

The announcement gave no reason for the change, nor did it say who will succeed Young at the FDA.

“Dr. Mason needed someone to work in this job; he thought Frank Young would be a good candidate for it, and Young decided it would be a good challenge,” said Jim Brown, a spokesman for the Public Health Service.

However, health department and congressional sources said that Young would have preferred to stay at the FDA and on several occasions had described his post as “the best job in the world.”

“This was not his idea,” said one HHS source who did not wish to be identified. “But it’s just been one thing after another at the FDA, and people were unhappy.”

Young has not been implicated in any wrongdoing, and several sources said that many problems at the agency are the result of an inadequate budget and insufficient resources.

The problems have included the growing scandal in the agency’s generic drugs division, which has been shaken this year by disclosures of bribery and mismanagement; attacks by AIDS activists and others unhappy with the FDA’s pace in making new therapies available to the desperately ill; and continuing criticism of the FDA’s performance in regulating food imports, medical devices and other items.

“He’s being made a sacrificial lamb,” one congressional source said. “They may think they have to throw someone out to appease people. It’s not his fault. He has a good record. Whenever he was made aware of something that was wrong, he acted on it.”

Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, whose oversight subcommittee has been conducting an aggressive investigation of the FDA, agreed.

“Frank Young had the misfortune to preside at the FDA during a time when it was virtually guaranteed that rogues and knaves would prosper and honest people would face great difficulties,” he said. “His intentions were good and he did his best when problems were brought to light. But he was handicapped by the budgets and attitudes of an Administration that let the agency go to seed.”

Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce subcommittee on health, called the FDA “one of our most important public health agencies” and said that Young “has worked tirelessly” as its commissioner.

The FDA “has faced numerous difficult circumstances in the last few years with a severe shortage of resources,” Waxman said, adding that he hoped the Bush Administration will back Young’s replacement “with much needed personnel and staff.”

HHS sources said that White House and HHS officials, including Sullivan and Mason, were irritated that Young was “too out front” and “always trying to grab the spotlight” in dealing with many issues and wanted him in a place where he would be far less visible.

“There was some heat from the White House over this,” the source said.

But Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group and one of Young’s most vocal critics over the years, said that Young’s “forced resignation . . . can only improve the health of the American public by removing someone whose industry-oriented decisions have cost hundreds of lives and injuries to many more.”

Young was appointed FDA commissioner in 1984 during the Ronald Reagan Administration by then-HHS Secretary Margaret M. Heckler. He presided over the agency during some of its most turbulent times. Problems he faced included the increasing urgency and challenges posed by the AIDS epidemic--where Young responded by initiating reforms aimed at accelerating the drug approval process for the desperately ill--and an international scare last year over Chilean grapes that had been tainted with cyanide.

But it was the growing generic drugs scandal, which erupted this year--coupled with increasing congressional oversight of the agency’s other regulatory failings--that created continuing headaches and embarrassment for Young.

An investigation conducted by the Justice Department and by Dingell’s subcommittee disclosed that employees in the FDA’s generics division had accepted bribes from generic drug company executives in return for accelerating agency approval of their drugs. Also, the investigation uncovered instances of fraud on the part of generic drug companies in submitting drug data that had gone unrecognized by the FDA.

Taken together, these raised serious questions about the generic drug industry, the quality of the drugs and the FDA’s ability to monitor them. “It was poor management and it happened on his watch,” one congressional source said.

The agency subsequently investigated generic drug companies that were suspected of having problems and tested the country’s most commonly used generics for safety and potency. Young is scheduled to present those findings to Dingell’s subcommittee at a hearing Friday.

In a statement Monday, Mason praised Young for his action on generics, saying that “consumers should have no concerns about generic drugs currently on the market. They are safe, and they work.”

Young, a pathologist and a microbiologist, was dean of the University of Rochester School of Medicine and Dentistry before coming to Washington. In his new post, HHS said, he will coordinate the development and utilization of technology, including biotechnology, nutrition and food safety, and physical science within the Public Health Service. The department said that he will also monitor technological developments “that can be expected to impact on the nation’s health care system.”