FDA panel seeks overhaul to improve effectiveness

June 5, 1991

The Food and Drug Administration needs more highly trained personnel,according to an advisory report on the agency released last month(SCAN 4/24/91). Additionally, the FDA must provide these workerswith the prestige and technical resources necessary to

The Food and Drug Administration needs more highly trained personnel,according to an advisory report on the agency released last month(SCAN 4/24/91). Additionally, the FDA must provide these workerswith the prestige and technical resources necessary to keep themon the job, the report said.

Most medical manufacturers can attest that inadequate staffinglevels and a rapid turnover of personnel at the FDA reduce theagency's effectiveness, causing delays in the product approvalprocess and other agency regulatory functions.

The HHS advisory committee on the FDA counted the need forgreater quantity and quality of scientific staff as one of manyreasons the FDA is often ineffective in carrying out its regulatorymandates.

"If you are going to regulate an industry, you have tohave the same level of capabilities that the industry has,"said Dr. Charles C. Edwards, committee chairman.

Edwards served as FDA commissioner from 1969 to 1973 and waslater assistant secretary of the Department of Health and HumanServices with responsibility for the FDA. He is currently presidentand CEO of Scripps Clinic and Research Foundation of La Jolla,CA. Edwards spoke with SCAN last week.

While the need for greater Congressional funding is one ofthe FDA's difficulties, it is by no means the only problem. Theadvisory committee recommended a broad range of changes at theagency, involving improvements in leadership, management systemsand organizational structure.

"There will always be limited resources. The FDA willnever live in the best of all worlds where they have all (theresources) they want," Edwards said. "A lot of thingscan be done without money."

The panel recommended separating the agency from the PublicHealth Service to streamline the regulatory process and give theagency the status and authority it needs. Greater visibility forthe FDA within the bureaucracy will help the agency recruit highlyqualified leaders. These leaders, in turn, will be better ableto attract highly qualified staff, Edwards said.

"You are not going to attract terribly talented peopleif you don't have terribly talented people recruiting them,"he said.

WELL-QUALIFIED SCIENTIFIC PERSONNEL cf142are hesitant to jointhe agency because the FDA's facilities and equipment are rundown and aging. Scientists often prefer to work with state-of-the-artequipment found in industry and academia, the report said.

"The committee considers it unacceptable for the FDA'sequipment and laboratories to fall so far behind the industriesit must regulate," the report said. "While there isno indication that laboratory work is deficient, the sorry conditionsare a risk to the quality and credibility of the agency. It isirresponsible to allow such conditions to continue."

The FDA should explore creative ways to improve facilitiesand equipment, including the use of lease-purchases for equipment,the report said.

The agency can improve its access to trained scientists andsophisticated equipment through greater cooperation with universities.Voluntary compliance by medical companies--in monitoring deviceperformance, for instance--is also an option for improving agencyeffectiveness, the report said.

"There is no question that the FDA has to work more closelywith responsible elements of the industries they regulate,"Edwards said.

The FDA needs to rationalize and modernize its network of testingfacilities within the constraints of limited resources, he said.

"Everybody would love to see a magnificent campus withall the component (facilities) together and all the equipmentthat is needed. But this is highly unlikely to happen in an eraof budgetary limitations. We have to look for the next best step,"Edwards said. "You can't have the FDA scattered around inmore than 30 facilities in Washington, with none of them havingadequate technology resources to do the job that needs to be done.It can't go on that way."

Regulatory review by the FDA is slowed significantly by theagency's pyramid review structure. This many-layered bureaucracyshould be reduced, the report said.

"It (the pyramid review structure) inevitably slows thingsdown," Edwards said. "Every time you have to go throughanother layer, they (the reviewers) have to start from scratch,basically repeating the process. The whole pyramid has to be reevaluated,"he said.