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Sullivan Will Name Panel for Review of FDA : Health: Critics say the agency has failed to ensure food and drug safety. Its departing chief has harsh words for Congress.

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TIMES STAFF WRITER

In a move aimed at restoring the credibility of the embattled Food and Drug Administration, Health and Human Services Secretary Louis W. Sullivan said Tuesday that he is forming an advisory panel to conduct a comprehensive one-year review of the agency.

Sullivan’s announcement came just a week before the departure of FDA Commissioner Frank E. Young, who fired a parting blast Tuesday at lawmakers who “grandstand” on FDA issues without providing enough funding to ensure that the agency can carry out its mandate.

The FDA has been a target of growing criticism in recent years from congressmen and consumer groups who contend that it has failed to ensure the safety of the food, drug and medical products it monitors or to make potential new treatments available to AIDS victims.

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“This advisory committee will explore current concerns about the FDA and develop policy or structural recommendations to address any problems they uncover,” Sullivan told the annual education conference of the Food and Drug Law Institute, a nonprofit group.

“It is clearly in the public interest for this committee to carefully examine every aspect of the FDA,” Sullivan said. He said he would give the panel a full year to study the agency and prepare its report.

Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, said creation of the commission may be too little, too late.

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“We can’t afford to wait (a year) for their report before we go ahead and make the necessary changes,” said a spokesman for Dingell, whose oversight subcommittee has been conducting an aggressive investigation of the FDA. “There’s just not that kind of time.”

Young, who has been characterized by sources on Capitol Hill and at the FDA as a scapegoat for the agency’s growing problems, will vacate his post Monday to become deputy assistant secretary for health, science and the environment at HHS.

Although his new assignment is higher in rank, the move was perceived widely as a demotion. A replacement for Young at FDA has not yet been named.

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The problems prompting the review have included disclosures of fraud, corruption and mismanagement in the agency’s generic drugs division, attacks by AIDS activists unhappy with the FDA’s pace in making new therapies available and continuing criticism of agency performance in regulating food imports, medical devices and other items.

In a separate farewell speech at the food and drug conference, Young defended the FDA and reprimanded lawmakers.

“We’ve had enough--too much--of politicians who view civil servants as part of the problem,” Young said, noting that the agency needs competitive salaries and better facilities. “To fully get through this, the FDA needs a little breathing room to reassess its priorities and to develop a strategy for the next decade.”

His comments reflected bitterness toward recent events.

“The agency deserves the guarantee of no new responsibilities without concomitant resources,” he said. “While the FDA is most willing to accept constructive criticism from the Congress, such criticism should be factually based and consistent with a reasonable assessment of agency priorities.”

The 13-member panel is expected to be formed in several weeks.

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