WASHINGTON _ Appearing before the House CommerceOversight and Investigations Subcommittee, FDA officials indicatedat a hearing Thursday that the agency is willing to negotiate onlegislation to streamline regulation of biotech products.

How fast the legislation can move through the House is problematic.The partisan controversy engulfing the budget reconciliation packageis putting into question the speed at which other legislation will beable to move to the House floor for a vote. "But nothing has beendecided," noted Karen Nelson, a senior aide to Rep. Henry Waxman(D-Calif.).

Subcommittee Chairman Joe Barton (R-Texas) did not specify whatshape his FDA reform proposals would take but said that, aside fromensuring that the product was "safe, pure and packaged safely, weshouldn't have to care about anything else.

"The market will tell you when to correct a problem," Barton said.Barton earlier questioned the use of the FDA's requirements that adrug firm prove clinical efficacy of a product. (See BioWorld Today,May 15, 1995, p. 1.)

FDA Deputy Commissioner for Policy William Schultz termed as"valid" many of the criticisms leveled by the biotech industry andpromised to sit down with subcommittee members to negotiate FDAreform legislation.

"We must balance the two goals of ensuring the safety andeffectiveness of drugs and getting drugs on the market quickly forthose who need them," Schultz said. "The question now is if we aredoing enough to get the drugs on the market fast enough."

Schultz sharply disputed contentions that the U.S. is lagging behindother industrialized nations in drug review time. The FDA comparedits review times to those in the U.K. for the years 1990 through 1994and found that more drugs were approved here than in that nation.Schultz blamed the industry for using old drug review data obtainedbefore the enactment of users fees, which the FDA said has speededreviews.

They've Got A Point

Schultz's remarks appeared to reinforce what FDA officials havebeen saying with increasing fervor in recent weeks: that the biotechindustry has some reasonable suggestions for FDA administrative andregulatory reforms and that some should be implemented.

Barton pressed the FDA witnesses several times about why they hadnot moved faster to facilitate the entry of clinically proven biotechproducts onto the market. But Barton maintained a nonpartisan stanceand pledged that he and other members of the subcommittee wouldwork with the Clinton administration to draft a reform bill.

He did, however, indicate he might hold a field hearing at FDAheadquarters in Rockville, Md. to review what managementimprovements the agency is implementing, including "quality circles,peer review, computerization and reducing the layers ofbureaucracy."

Rep. Ron Wyden (D-Ore.), who often said "the cookie cutterregulations that work for drugs don't work for biotechnology,"repeated industry statements that the biotech industry has clearlyoutpaced the regulatory system. Wyden reminded FDA officials thatthe biotech industry several years ago approached the FDA about theneed for a biotech regulatory apparatus that worked and the "agencydid not respond.

"The industry has valid points. You need to listen to them," Wydentold Schultz.

Former subcommittee chairman Waxman, whose posture on FDAreform will be a sentinel for many Democrats on the CommerceCommittee, pointedly referred to those in Congress "who suggest wedon't need FDA," as he carefully elicited a statement from AmgenInc. President and CEO Gordon Binder that Amgen, of ThousandOaks, Calif., supports retention of the safety and efficacy standard toclear drugs for marketing.

"It is significant that we would do 95 percent of the testing the FDArequires. Our problem is the review time," Binder stated.

Binder set the tone for the hearing when he recalled the story ofAmgen's Puerto Rican manufacturing facility sitting idle for nearly12 months while the company awaited final inspection approval.

"Following inspection, we were asked only five questions which weanswered and delivered to the FDA in short order. During the periodbetween inspection and approval, our highly technical manufacturingstaff, totaling more than 200 personnel, was required to operate at asubstantially reduced product schedule and no lots could be released.The delay cost Amgen millions of dollars," he told the subcommittee.

Binder urged that the subcommittee permit the FDA to move a"substantial amount of testing" outside the agency to privatereviewers, enabling the agency to free up resources for clinicalreviews. Noting that two-thirds of the requests to conduct clinicaltrials come from academic centers, Binder urged the FDA to farmthose reviews out to private firms to focus its limited resources oncommercial product reviews.

Details To Come . . .

The FDA is expected to announce soon the procedures wherebymanufacturing supplements can be reduced by 50 percent. About 25percent of the changes could be made unilaterally by a biotech firmand the other 25 percent would require giving the agency 30 daysnotice. The remaining would require FDA review because they arerelated to safety and efficacy.

Amgen's experience with the FDA was validated by a PriceWaterhouse survey released Thursday which found that of the 122West Coast companies surveyed, many indicated they would chargeless for their products if the FDA reviewed them more quickly.Binder said Amgen could cut the price of its products by 10 percentif FDA reviews were streamlined. The survey was conducted incollaboration with the University of California at San Diego.

Barton was receptive to Binder when he explained that U.S. drugfirms are permitted to market investigational drugs only to a limitedlist of 21 foreign countries. "If the country wants a product, thenthey'll get it from someplace else," Binder said. "We need to removethe FDA from the step of approving a drug's foreign languagelabeling and instead limit it to regulating the testing of the finalproduct."

Thursday's hearing continued what promises to be a long debate onFDA reform. The next step will be an as yet unscheduled hearingbefore an authorizing committee chaired by Rep. Michael Bilirakis(R.-Fla.). n

-- Michele L. Robinson Washington Editor

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

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