Advisory committee seeks stronger FDA

An independent advisory committee report on the Food and DrugAdministration, due next month, will suggest additional fundingfor the beleaguered agency. No specific amounts will be mentioned,however, and it is unclear what the Department of Health and HumanServices or Congress is willing to spend.

"It (the advisory report) may be used effectively by FDAsupporters to argue for more money, both within the administrationand on the Hill," said Frank Samuel, chairman of a subcommitteeof the advisory panel focusing on medical device requirements.

"While it may not make a huge difference in the currentbudgetary climate, anything that can add leverage on behalf ofmore FDA resources is a real plus," he said.

Samuel was president of the Health Industry Manufacturers Associationfrom 1984 through 1989. He is currently president of GovernmentStrategy Associates, a Washington, DC, consulting firm.

The FDA may not receive all the funds it deems necessary todeal with its expanded duties under the Safe Medical Devices Actof 1990 and about 10 other pieces of Congressional legislation.The advisory committee will, however, recommend strengtheningthe agency's regulatory authority and autonomy.

The report will suggest to DHHS secretary Louis Sullivan thatthe FDA be given authority to issue its own regulations. It willalso recommend that the agency report directly to the secretary,rather than indirectly through the Public Health Service.

"They (the advisory committee) are calling for the FDAto be taken out of the Public Health Service and elevated to aposition equal to the PHS within the bureaucracy, so there willnot be as many layers of review that regulations have to go through,"said Carol Cooke, communications director for the advisory committee.

Prior to 1981, the FDA commissioner had greater authority toissue regulations directly. Subsequently, however, the commissionerhas had to go through both the DHHS assistant secretary, who headsthe Public Health Service, and the secretary in order to haveregulations approved, she said.

"We must do everything we can to ensure that the FDA holdsits own and doesn't slip even farther behind in terms of expertise,facilities and equipment," Samuel said.

Even when regulations are on the books, the agency is not alwaysable to enforce them. Violations with negative public health implicationsrather than economic consequences are more likely to be targetedfor enforcement, Cooke said.

This lack of enforcement has led to the suggestion that privateindividuals and companies be allowed to sue competitors when theybelieve there are infractions of the Food and Drug Act. This isa controversial idea among members of the committee and is stillunder debate. It is only a suggested tactic and not a major committeerecommendation, Cooke said.

A recommendation that should please medical imaging manufacturersis that the agency pay closer attention to the harmonization ofinternational regulations and build a stronger international presence,Samuel said.

"The diagnostic imaging industry is obviously a globalindustry. While the report does not specifically mention imaging,this (encouragement of the FDA's international role) was one ofthe points raised by the imaging industry in their appearancebefore the committee. The recommendation should be read as supportiveof this industry position," he said.

Secretary Sullivan is free to do what he wishes--or to do nothing--withthe report. The secretary set up the independent advisory committeeabout a year ago, and it will disband when the report is issuedon May 15, Cooke said.

The committee's advice may also be considered by oversightcommittees in Congress, which have expressed informal interestin the report, she said.

BRIEFLY NOTED:

• James Benson, deputy commissioner of the Food and DrugAdministration, has been chosen as acting director of the Centerfor Devices and Radiological Health, effective in June. Bensonwill replace current acting director Walter Gandaker, who is retiring.Benson served as deputy director of CDRH from 1982 to 1988.

• Both EDAP and Diasonics received a recommendation forconditional approval of their renal lithotripters at a meetingthis month of the Food and Drug Administration's gastroenterology-urologydevices advisory committee. Diasonics hopes to begin U.S. shipmentsof its Therasonic system in the second half of 1991, said presidentRod Young.