WASHINGTON _ Rep. Joe Barton (R-Tex.), chairman of theHouse Commerce Oversight and Investigations Subcommittee, madea tough talking speech Friday to a group of industry executives thatgave considerable currency to their drive to simplify FDA productreviews.

Barton told a group of medical device industry executives that he isconsidering a wide range of unconventional approaches to FDAreform, including lowering the efficacy standard and moving entireblocks of the FDA bureaucracy into a non-regulatory agency. Hereferred to FDA as the "Foot Dragging and Alibi Association."

Barton said he definitely sees a role for the FDA to determine if aproduct is safe but applying an efficacy standard would involvequantification of a "perceived risk that could hang you up forever."

If Barton moves the debate too far to the right by proposing sweepingchanges in the FDA, he runs the risk of alienating those who view theagency as a guardian of U.S. public health. And that could spell theend of FDA reform this year, a biotechnology lobbyist toldBioWorld.

If Barton's proposals for FDA reform eclipse those sought byindustry, he may force ranking Democrat Rep. Henry Waxman (D-Calif.) into a more partisan role in support of the FDA and theClinton Administration.

So far, Waxman, Barton, House Commerce Health SubcommitteeChairman Michael Bilirakis (R-Fla.) and Rep. Ron Wyden (D-Wash.)have made an effort to appear bi-partisan in their criticism of theFDA.

Barton told the device manufacturers that their FDA reform plan "didnot go far enough" and that FDA "is guilty unless proven otherwise.By that I mean the agency will have to prove your legislativeproposal is not sound."

FDA Hearings Continue May 25

Barton said he was considering moving the Center for Devices andRadiological Health (CDRH) out of FDA and the Public HealthService into an environment "such as the National ScienceFoundation where you can get a clear view and focus on technology."

Barton will continue his hearings on FDA reform, which began in lateMarch, on May 25 when he hears testimony regarding the regulationof drugs and biologics. FDA officials are hopeful they will beinvited, but the final witness list has not been developed.

"The goal of the hearing is to determine the facts" surrounding theregulation of drugs and biologics, Barton said. "We sent a detailedletter to the FDA about manpower levels and allocation of resources.They have complied with our request but it was unsatisfactory,"Barton stated.

Barton said he has no preconceived ideas about how FDA regulationof biotechnology should be changed. But he stressed, "I am not asafraid of genetic engineering as some consumer advocates are. Weneed to address the biotech issues."

House Speaker Newt Gingrich (R-Ga.) is committed to moving FDAreform legislation through the House.

"I talked with the Speaker yesterday and he told me he wasinterested in helping to move the FDA legislation," Barton said.

FDA `Culture' Called Outdated

Barton confirmed that his panel would be working to draft an FDAreform bill with Bilirakis, whose authorization subcommittee isempowered to amend FDA's enabling statute. Barton's subcommitteeonly has oversight and investigative powers and cannot initiateauthorizing legislation.

However, as the debate on budget cuts becomes more and morecontentious, doubts are fading that Congress will have time to turn itsattention to other legislation, including FDA reform.

"When I came to this job four months ago I did not think we neededFDA reform legislation. Now I am of more of the opinion that wedo," Barton told the manufacturers.

Barton praised the Clinton Administration for its reinventing FDAblueprint announced in early March. "But they have not doneanything to act on it," he stated.

He promised the company executives that "we will change the cultureat the FDA." Barton added, "FDA Commissioner [David] Kesslerand his staff are good people. But it is ridiculous that it takes as longas it does to complete product results. We are going to bring the FDAinto the 20th century before the 21st begins." n

-- Michele L. Robinson Washington Editor

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