Charging that the Department of Health and Human Services has neglected the Food and Drug Administration and failed to enforce its congressional charter, several key members of the House Energy and Commerce Committee said yesterday that the agency would be better off on its own.
The call for an independent FDA came as HHS Secretary Louis W. Sullivan appeared before the committee's oversight and investigations subcommittee to explain his attempts to rebuild the beleaguered agency.
Coming less than a week after a federally appointed Blue Ribbon Panel on the FDA raised the same issue during a public hearing, the House members' sentiment also reflects the growing conviction of many policy-makers that the FDA must be given increased authority and independence to effectively fulfill its mandate.
"We in Congress are looking for evidence to determine whether or not the FDA has become so lost in the giant HHS bureaucracy that it must be freed in order to have its problems adequately addressed," committee Chairman John D. Dingell (D-Mich.) said. "Nothing less than the public health is at stake."
But under questioning from subcommittee members about the merits of breaking the FDA away from HHS, Sullivan responded sharply, saying that such a plan would be "disruptive" and a "detriment to all citizens."
"I am secretary of health and human services," Sullivan said. "Drugs, medical devices and foods are an important component of that responsibility."
Sullivan said that breaking FDA out of the department would frustrate the ability of the various constituents of HHS -- from the National Institutes of Health to the Centers for Disease Control -- to work together.
Sullivan's remarks came during more than two hours of close questioning by subcommittee members on issues such as the sharp drop-off in generic drug approvals since the scandal last summer and his department's handling of criminal investigations into alleged violations of the Food, Drug and Cosmetic Act, the FDA's charter.
Sullivan promised changes including establishment of a special office to review generic drug applications, appointment of 30 more investigators to improve FDA's fraud enforcement and creation of an FDA ombudsman to investigate problems in the agency.
Sullivan said he too had been "horrified by past improprieties," but defended his response as "vigorous, responsible and credible."