Sullivan Plans to Revamp FDA in Wake of Scandals

Responding to congressional suggestions that the Food and Drug Administration be made an independent agency, Health and Human Services Secretary Louis W. Sullivan announced Wednesday that his department will make a series of structural and personnel changes to improve the agency’s management.

Sullivan, speaking before a House Energy and Commerce subcommittee, said that the changes “demonstrate the Department’s commitment to address the problems plaguing FDA.” He added that removing the FDA from his department would “lead to fragmentation of our health effort.”

But Chairman John D. Dingell (D-Mich.) of the oversight and investigations subcommittee insisted that the department’s pattern of mismanagement and neglect have led members of his subcommittee to question whether the FDA should have HHS oversight.

In the last year the FDA has been rocked by a series of scandals, including revelations that manufacturers of generic drugs falsified laboratory data and bribed agency officials to gain government approval of their products.

In addition, the subcommittee has charged the FDA with shoddy regulation of the blood supply, food imports and medical devices such as artificial heart valves.

Sullivan’s promised changes include the establishment of a special office to review generic drug applications, the appointment of 30 more investigators to improve FDA’s fraud enforcement and the creation of an FDA ombudsman to investigate problems within the agency.

Dingell also criticized Sullivan’s decision to stop using his department’s inspector general to investigate cases of generic drug fraud. In July, 1989, Sullivan authorized the inspector general to look into charges involving felonies but rescinded that authorization last January when the Department of Justice told him the policy posed legal problems.

Sullivan defended his action.

Dingell criticized Sullivan for failing to name an FDA commissioner since the job became vacant more than eight months ago and accused the Bush Adminstration of putting the FDA on a “starvation diet” by failing to request an adequate budget for the agency.