WASHINGTON _ Rep. Joe Barton (R-Tex.), who hasbeen one of the FDA's most outspoken critics this year inthe GOP-led Congress, Tuesday turned up the intensity ofhis criticisms of the FDA and outlined a reform plan thatis far to the right of what most drug manufacturers haveproposed.

Barton advocated sharply limited review times for newproduct approvals and delegation of decisions about theefficacy of drugs to health care practitioners.

Barton spoke before a conference sponsored by theNational Policy Forum, a conservative policyorganization funded by the Republican NationalCommittee.

Barton has scolded the FDA on several occasions but hisspeech Tuesday contained some of the toughest criticismshe has leveled against FDA.

Rep. Mark Souder (R-Ind.) cautioned the conferenceabout making fundamental changes in the way FDAregulates medical products. "There is a perception held bythe American people that while the Democrats areadvocates of big government," the Republicans are"doing the bidding" of those making profits from the saleof drugs and devices, Souder said.

David Beier, vice president, government affairs forGenentech Inc., called Barton's FDA reform plan"reasonable" but said it was premature to considerendorsing it until he had a chance to examine actual billlanguage.

While not engaging Barton directly on the specifics of hisFDA reform plan, Jim O'Hara, FDA's associatecommissioner for public affairs, said that any proposedreform "should be judged on how well it protects andpromotes the public health. That's what this agency andadministration is committed to do. The FDA is workingon a number of reforms announced earlier this year and isworking on a number of others," O'Hara said in aninterview with BioWorld Today.

Following are the highlights of Barton's FDA reformplan:

Thirty-Day Reviews Of New Drug Applications (NDA).Charging that the FDA averages 14 years and can takes aslong as 20 years to review a manufacturer's NDA, Bartonsaid Congress should include a definite deadline for theFDA to meet. "A manufacturer should be able to submitan NDA and get an answer in 30 to 60 days, no questionsasked," Barton said. "It takes the FDA only 30 days tomake a decision about a drug once the drug reviewer isfinished, but it usually takes two to three years to get tothat stage."

Eliminate The Efficacy Standard. Admitting that hisviews were controversial, Barton said he was convinced"that the marketplace can determine the efficacy ofdrugs." Congress should "either set some parameters inthe law or simply remove it. We should let the doctorsand the hospitals and the patients determine if a drug isefficacious."

Eliminate Good Manufacturing Practices (GMP). Sayingthat he would "eliminate FDA's manufacturing oversightaltogether," Barton will seek limits on how the FDAinspects a company's plants for GMPs. FDA inspections,he said, should be confined to assessing the "purity orquality" of the product but not where a manufacturer"puts the light switches."

Shorten Review Process. Barton said that he has 10proposals to expedite product approval applications butsaid he endorsed "one that would permit outside groupsto do most of the reviews. This peer review body wouldhave real power and would make a binding decision thatcould be overturned only if the FDA found a flaw withthe review process itself." Barton said he "wouldn't makeit totally binding" but would "put the burden of proof onthe FDA to determine if the decisions by the outside bodywere fatally flawed."

Drugs Approved Overseas. If the European Communityhas approved the manufacture, distribution and use of adrug then it should be cleared by the FDA formanufacture in the U.S. and available for shipmentoverseas," Barton said, adding that he supports acomparable provision that is contained in Rep. RonWyden's (D-Ore.) FDA reform bill.

Summary Of Data. Recalling his days in the early 1980sas a White House Fellow, Barton told the conference thatthen President Reagan demanded that decision memos bekept shorter than two pages. He contrasted that anecdotewith a recent visit to a drug company where he viewed anNDA that exceeded 6 million pages. Barton said heintends to seek a reduction in the amount of material thatmust be included in NDAs and permit manufacturers tosubmit summary data.

Improving Biotech Drug Reviews. Calling the regulationof biotech drugs "something new for the FDA" Bartonsaid he "doubted if the FDA has the expertise in thisarea," and urged that "these reviews be contracted tooutside review organizations."

Appeals Process. Barton said the FDA's current appealsprocess is "so cumbersome" that it should be replaced."There is no way to dispute FDA decisions," he stated.

FDA Mission Statement. Barton told the conference thathe has testimony "on the record" that FDArepresentatives "view their role as a police agency."Barton countered that a possible mission statement was"to facilitate the rapid and efficient development andavailability of safe and effective products that benefitAmericans."

New Management Structure. FDA officials need to"determine what their old management structure" wasbefore they can install a new one. Barton said that hissubcommittee has testimony from FDA officials "whocould not tell me how many layers of management therewere at the FDA or how many people were employed byFDA." Barton also said that he "was told" that FDACommissioner David Kessler "has more people on hispublic relations staff than he has on managementoversight. If that is true, it is a potential indictment of thecurrent management structure."

Scientific Policy Committee. To extricate the FDA fromwhat Barton called its "fortress mentality," he advocatedestablishing a scientific policy committee that wouldmeet regularly with the Office of the FDA Commissionerto keep them current on trends in medical research.

End FDA Bench Work. Barton said that researchconducted by FDA scientists "is not of much benefit" andbelieves there are many American researchers in theprivate sector and academia who could perform the work.

While FDA reform is not in the House GOP leadership'sContract with America, it is right below those bills interms of priority, Barton said. "If it hadn't been for theApril 1995, report to do something about Medicare [trustfund] immediately, we probably would have already hadan FDA reform plan by now." n

-- Michele L. Robinson Washington Editor

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