WASHINGTON _ Two former top FDA officials today told theSenate Labor and Human Resources Committee that the FDA needsto be equipped with better management and a focused regulatoryagenda to speed biotechnology products to market.

Wednesday's hearing was the first of two congressional hearings onhow to reform the FDA.

Charles Edwards, who served as FDA commissioner from 1969 to1973, and is now with the Scripps Research Institute, La Jolla, Calif.,told the committee to keep the FDA "strong and give it the resourcesto do its job" but not permit the agency to "stray beyond its coreduties." The consequences will be devastating, not only for theagency but also the industries it regulates and the people who dependon FDA-regulated products.

Former Acting Commissioner Mark Novitch, now professor atGeorge Washington University, agreed. He said the FDA shouldadvance and promote the public health by encouraging the trendamong consumers to obtain information about all health careproducts and the "continuing unmet need among physicians and otherhealth professionals for specific information about valid and well-recognized drug uses that are not included in FDA-approved druglabeling."

Committee Chairwoman Nancy Kassebaum (R-Kan.) did not makeany of the highly charged criticisms of the FDA that have beenlodged by some House Republicans. She focused her openingstatement on challenges facing the FDA rather than a wholesaledenunciation of the agency. "FDA not only has the responsibility toensure the safety and efficacy of new biomedical and foodtechnologies but also must ensure that individuals and the nation as awhole have timely access to those technologies now and in thefuture," Kassebaum said.

Many of the committee members' questions were directed at currentFDA Commissioner David Kessler, who will appear today at thesecond day of hearings. When Sen. Judd Gregg (R-N.H.) asked if theFDA's anti-industry attitude is cultural and resistant to change,Edwards attributed 70 to 80 percent of the FDA's attitude to theinstitutional culture, saying it was "a reflection of the guy at top. Ifthe attitude at the top is that the industry is the enemy, then that goesdown through the ranks," Edwards said.

Sen. Tom Harkin (D-Iowa) said that the "FDA should not be a barrierto the biotech industry. FDA is too slow, too bureaucratic. In its questto save the public from a potentially disastrous event, it is denyingthe American people needed therapies."

Kassebaum's panel is expected to draft a more moderate FDA reformplan that those circulating in the House. Kassebaum and RankingDemocrat Sen. Edward Kennedy (Mass.) have a long-standingcollaborative relationship that is likely to produce a consensus FDAreform plan, lobbyists told BioWorld.

Kassebaum's hearing set the stage for today's testimony from Kesslerabout how the Clinton Administration intends to advance its FDAreforms.

Straying From The Mission

In an indirect criticism of Kessler, Edwards faulted the FDA forstraying from its core mission of protecting the public health,approving new products and providing appropriate information toconsumers and users. Instead, the agency continues to be plaguedwith poor management, and remains unable to establish priorities toguide the agency's daily operations, he stated.

"FDA's paternalistic tendency in recent years is more than badpolicy. It is also bad management by diverting limited resources fromkey tasks, like drug and medical device approvals," Edwards said.These deficiencies have led to "predictable and inevitable lags in theapproval process of new drugs and a staggering backlog of medicaldevice approvals."

Novitch urged Congress and the FDA to monitor carefully theEuropean Medicines Evaluation Agency, established to assure thatreviews done by the FDA or European nations are recognizedthroughout the European Union. Its decisions about drugs andmedical devices could serve as the basis for approval decisions by theFDA, he stated. Noting that European manufacturers use the sameclinical testing, laboratory, and manufacturing practices as their U.S.counterparts, Novitch said the FDA should be exchanginginformation rather than staying apart.

For reform efforts to be successful, Edwards said Congress must gobeyond treating the symptoms but address the cause as well. "Wecould accelerate the drug approval process by eliminating the longstanding requirement that new drugs must be proven safe andeffective before they are marketed. But we would be treating asymptom_the slow review process _ rather than treating the realproblem: poor management," Edwards said.

The FDA should not act like the "enemy" and instead shouldfacilitate approval of new products, Edwards told the committee. TheFDA has apparently disregarded the recommendations of an Healthand Human Services advisory committee that said facilitating"approval of useful and safe products can be as important aspreventing the marketing of harmful or ineffective products."

Edwards reserved his harshest criticism for the FDA's decision toapply the standards of clinical drug testing to studies of cost-effectiveness. While drug prices are important they are "not part ofthe FDA's responsibility to ensure that new drugs are safe andeffective."

The FDA's limited resources could be conserved by giving moreauthority to institutional review boards to review and approveinvestigational new drug applications. The FDA would retain thepower to halt an investigation if adverse events developed, bothEdwards and Novitch told the committee.

Edwards also recommended that the agency accept certain drugapplication data in summary form, with companies making moredetailed data available upon request. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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