WASHINGTON -- The Food and Drug Administration requiressignificant administrative, managerial and technologicalreforms if it is to meet the challenges of the coming decade,especially those posed by burgeoning demands of thebiotechnology industry, according to a blue ribbon federaladvisory panel.
The report paints a picture of a mismanaged agency,understaffed and underfinanced, barely able to cope withcurrent demands and unprepared for future contingencies.
Dr. Charles Edwards, president of Scripps Clinic and ResearchFoundation and a former FDA commissioner, on Wednesdaypresented the final report of the 15-member AdvisoryCommittee on the Food and Drug Administration to Health andHuman Services Secretary Louis Sullivan.
Sullivan and Edwards also testified Wednesday on the report'sfindings before the Senate Committee on Labor and HumanResources. While Sullivan endorsed some less controversialfindings, he did not commit to implementing more radicalmeasures that would undermine his authority.
The Edwards Commission called for administrative changes thatwould increase the power and prestige of the FDA in generaland of the FDA commissioner in particular. The report'srecommendations include:
-- redelegation to the commissioner of authority to issueregulations, which had been revoked by the Reaganadministration; and
-- removal of the FDA from the Public Health Service (PHS).
The report suggests that the commissioner should reportdirectly to the secretary of Health and Human Services. But "ifthe FDA is not removed from PHS and its authority to issueregulations restored, the Congress should consider establishingthe FDA as a free-standing agency," it said.
Responding to questions from the lawmakers, Sullivan resistedmoving the FDA from PHS and deflected a question aboutgranting the commissioner rule-making authority.
Many recommendations focused on the biotechnology industry.Predicting "an explosion and tidal wave" of new biotechnologyproduct applications in the near future, the committeerecommended:
-- development of a conditional approval designation linked toa required Phase IV post-marketing surveillance system;
-- either merging or enhancing the coordination between theCenter for Drug Evaluation and Research and the Center forBiologics Evaluation and Research; and
-- increased use of advisory committees.
Other recommendations include congressional legislationpreempting additional and conflicting state requirements for allproducts subject to FDA jurisdiction.
The Industrial Biotechnology Association and Association ofBiotechnology Companies broadly support the EdwardsCommission's findings.
-- Steve Usdin BioWorld Washington Bureau
(c) 1997 American Health Consultants. All rights reserved.