WASHINGTON _ Just days before the White House is expected tounveil its plan for FDA reform, Rep. Ron Wyden (D-Ore.) hasentered the fray with one of the most comprehensive proposals yetoffered.

Wyden proposed a 14-point agenda for FDA "reform and renewal"on Tuesday that includes decreasing pre-market efficacyrequirements for drugs in exchange for increased post-marketingsurveillance, granting time-limited market approvals for breakthrough drugs on the basis of asingle pivotal trial, reducing or eliminating altogether FDA oversightof Phase I studies, and allowing independent accreditation and testinglabs to perform some FDA functions.

In a letter sent to both President Clinton and House Speaker NewtGingrich (R-Ga.), Wyden said the FDA needs to update its policies inorder to serve both "consumers and entrepreneurs."

"A competitive industry and consumer protection are not mutuallyexclusive ideas," stated Wyden in the letter. "I firmly believe thepublic health mission is compatible with entrepreneur-friendlypolicies that more quickly bring new, health-sustaining products tothe consumer and create additional jobs."

Sources told BioWorld that the Clinton Administration plans tounveil its detailed proposal for FDA reform, developed under theaegis of Vice President Al Gore's "Reinventing Government"program, later this week. (See BioWorld Today, March 17, 1995, p.1, for highlights of the plan). FDA Commissioner David Kessler, whowill appear before the Senate Labor and Human ResourcesCommittee on Thursday morning, is expected to outline the WhiteHouse proposal in his testimony.

Although Republicans put FDA reform on the political map in 1995_ Gingrich called the agency the "leading job killer in America" andlabeled Kessler a "bully and a thug" in speeches and interviews latelast year _ the GOP has yet to offer a concrete, comprehensive planfor change. But Republican lawmakers in both the House and Senatehave launched investigations.

Sen. Nancy Kassebaum (R-Kan.), chairwoman of the Labor andHuman Resources Committee, will preside over FDA hearings onWednesday and Thursday and Rep. Joe Barton (R-Texas), chairmanof the House Commerce Committee's Oversight and Investigationssubcommittee, held the first in a series of FDA hearings last week.(See BioWorld Today, March 31, 1995, p. 1.)

On the legislative front, Rep. Fred Upton (R-Mich.) and Sens. OrrinHatch (R-Utah) and Judd Gregg (R-N.H.) introduced legislation inthe House and Senate last month to ease export restrictions on non-FDA-approved drugs and devices, a hot-button issue for industry.(See BioWorld Today, March 23, 1995, p. 1.)

To some observers, it now appears that lawmakers from both sides ofthe aisle are jockeying to outdo one another in overhauling theagency. "I'm certainly happy to see this sort of competition takingplace," observed Carl Feldbaum, president of the BiotechnologyIndustry Organization (BIO). BIO has lobbied hard for FDA reform,arguing that the current regulatory environment threatens the healthof the biotechnology industry.

Improving Survival Rates And Competition

Wyden aide Steve Jenning told BioWorld that Wyden's proposalseeks to shift some of the burden of FDA regulation from pre-marketing requirements to post-marketing surveillance. Such a move,he said, would not "pose a problem" for consumers while it couldsubstantially "improve survival rates and competitiveness" formanufacturers.

"He is particularly concerned about small, entrepreneurial firms withcutting-edge technologies," said Jenning. Wyden's proposal calls forthe following reforms, among others:

* The FDA should relax requirements for pre-market assessment ofefficacy, including limited pre-market testing requirements for low-risk devices and limited "Phase III clinical reporting demands" fordrugs, in return for broader post-market surveillance and reporting.

* For breakthrough drugs, the FDA should grant "modified and time-limited" marketing approval on the basis of "one pivotal Phase IIIclinical trial with a sound clinical design." If follow-up studies failedto reproduce the results of initial studies, the FDA could extend the"modified approval" while waiting for more data or withdraw theproduct from the market.

* The FDA should reduce or eliminate its supervision and review ofPhase I clinical trials by relying upon local institutional reviewboards (IRB) at the sites where these trials are typically conducted.Authority over Phase I trials would be consolidated at the IRB levelunder the "exclusive jurisdiction" of the FDA, thus removing theNational Institutes of Health's involvement.

* Manufacturers should get incentives to do "high quality clinicaltrials to demonstrate the comparative quality differences" betweenseveral drugs or devices for treating a given ailment, especially forbreakthrough drugs. "Accelerated pre-market evaluation" could beawarded to those manufacturers who perform such comparative trials,with both the FDA and the Agency for Health Care Policy andResearch evaluating such studies.

* The FDA should allow independent accrediting and testing labs toevaluate low-risk devices using FDA standards. If successful, theprogram could be expanded to include implantable devices anddrugs. Wyden proposed that user fees collected from drug and devicecompanies could be used to pay for third-party evaluations. Inaddition, he suggested that accrediting organizations could conductgood manufacturing practice (GMP) compliance plant inspections,toxicological study analysis, validation of assays and "lot" releasequality control checks _ all tasks currently performed by the FDA.

* Biotechnology companies should be allowed to make minormanufacturing changes without pre-inspection and the FDA shouldgrant GMP approval for material produced at pilot plants, allowingproducers to forego building full-scale manufacturing facilities priorto marketing approval.

* The FDA should consolidate its review of biologics under a singledivision, depending on the use of the individual product or,alternatively, should assign an inter-disciplinary team to follow anapplication from beginning to end. For example, in vitro diagnosticproducts _ which are currently subject to the overlappingjurisdiction of the Center for Biologics Evaluation and Research andthe Center for Devices and Radiological Health _ should beconsigned solely to one division.

Other proposals made by Wyden include forcing the FDA, by fiat orstatute, to meet device review deadlines; further harmonizing U.S.and industrialized world drug and device standards; eliminating someexport barriers for non-FDA-approved drugs and devices; focusingregulatory oversight on the most dangerous and complex devices;making FDA enforcement and inspection practices more consistent;and modifying off-label use laws to allow for the exchange of"important new information on drugs and devices."

BIO's Feldbaum called Wyden's proposal a welcome step in thedirection of "real FDA reform" and away from "rhetoric." But whileJenning predicted that many of Wyden's reforms could be achievedby "administrative changes or executive fiat," Feldbaum maintainedthat legislation is the only safe haven for the biotechnology industry."Directives and guidelines leave us vulnerable to the bureaucraticwhim of another administration, either in the White House or at theFDA," he argued.

FDA spokesman Jim O'Hara told BioWorld that the agency hasreceived Wyden's proposal and is "looking it over" and had nofurther comment. n

-- Lisa Piercey Special To BioWorld Today

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

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