WASHINGTON _ FDA reform legislation came one step closer toenactment Tuesday when Rep. Ron Wyden formally introduced hisbill to simplify the reviews biotechnology companies must completeto prove the safety and efficacy of their drugs.

Wyden (D-Ore.) announced his intention to push for FDA reformlegislation more than two months ago. (See BioWorld Today, April5, 1995, p. 1.) He delayed introducing his bill, the FDAModernization Act of 1995, until Tuesday because of the technicaldifficulties involved in making educated judgments about the issues,said Wyden aide Josh Kardon.

Wyden, who has expressed an interest in working with theRepublicans to craft a bipartisan FDA reform plan, hopes to obtain acommitment soon from House Commerce Committee ChairmanThomas Bliley (R-Va.) to press ahead with hearings later this year.House Commerce Oversight and Investigations SubcommitteeChairman Joe Barton (R-Tex.) last week told BioWorld Today thathe would work with Wyden to craft a bipartisan FDA reform plan.

Wyden, who has often said FDA regulation of biotechnology firmshas been eclipsed by their technology, said his bill, HR1742, "laysthe foundation for a modern FDA that is good for consumers,taxpayers and entrepreneurs with cutting edge technologies."

Wyden's proposed legislation was introduced as a consensus isgrowing in Congress that FDA needs fundamental reform. A largenumber of House Commerce Committee members who attendedBarton's hearings on FDA reform two weeks ago agreed that FDAmust be reformed. The only question is how much.

Wyden Willing To Compromise

Wyden has worked carefully with the Biotechnology IndustryOrganization, Washington representatives for large biotech firms aswell as FDA officials to craft what he hopes is a compromise thatmeets industry's needs for faster approvals and the FDA'scommitment to protect the public health.

Wyden is not seeking any co-sponsors for his bill at this time but iswaiting for a bipartisan consensus to coalesce before he seeksbackers, Kardon said.

In his statement accompanying the introduction of the bill, Wydencriticized FDA for regulating too tightly drug firm's claims abouttheir products.

"Health maintenance organizations and other health providersdeserve access to ground breaking information that can help theirpatients and reduce costs," Wyden stated. "This requires a balancebetween having no rules for the dissemination of information and thecurrent FDA gag rule on scientifically valid articles."

Manufacturers would be able to disseminate scientific journal articlesand other publications that discuss their products as long as theysubmit the materials for FDA review at least 60 days before they planon distributing them.

In an obvious concession to FDA, Wyden's bill retains FDA's powerto demand validating data from manufacturers and gives the agencyequal time to include its response on whether the information wasscientifically balanced. These new procedures apply to drugs alreadyapproved for at least one indication.

Wyden's bill responds to complaints from industryand others that FDA has made market entry standardsfor biotechnology products too high and regulations too burdensome.

The proposal rewrites the FDA's mission statement to stipulate that afundamental part of its mission is to make rapid decisions onapplications for new drugs, biologics and medical devices.

Wyden, who has criticized the FDA for applying "cookie cutter"regulations created for other medical products to biotechnologydrugs, would separate the review standards for synthetic andbiotechnology drugs.

New drugs to treat life-threatening diseases if found to be safe andeffective could be conditionally approved for marketing on the basisof a single well-designed clinical trial.

In addition, the proposal streamlines the market entry process forbiotechnology drugs and beefs up post-marketing surveillance. Human tissues would be defined for the firsttime for purposes of FDA regulation by establishing standards and afinal regulatory scheme.

Bill Would Privatize FDA Functions

Wyden's bill also would speed FDA product reviews by privatizingseveral FDA functions. Outside panels of experts, independent testingorganizations and institutional review boards would be authorized tomake recommendations to FDA on Phase I trials.

In addition, Wyden's bill imposes a 30-day deadline on FDA toapprove or deny Phase I applications. The agency would be requiredto meet with a manufacturer within 30 days of receipt of a company'sapplication for approval of an investigational protocol.

Independent testing organizations would have the authority toperform toxicology reviews, chemistry reviews, statistical analysis,pre-approval manufacturing practice reviews and other functionsdeemed appropriate.

Manufacturers could appeal adverse FDA findings to outside panelsof experts or request a review of a proposed remediation to a criticaldetermination by FDA.

Good manufacturing practices (GMP) regulations would be refinedso that separate rules are crafted for synthetic and biotechnologydrugs. Regulation of blood and blood products would not bechanged. But manufacturers could make minor changes in the GMPprocesses without obtaining FDA approval. n

-- Michele L. Robinson Washington Editor

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

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