SAN FRANCISCO _ House Speaker Newt Gingrich promised a"substantial overhaul" of the FDA this year and said the agency'slengthy drug-review process has resulted in more lives lost for lack ofapproved drugs than it has saved from unsafe products.
Speaking via videotape Monday to the annual convention of theBiotechnology Industry Organization (BIO), Gingrich (R-Ga.)proposed speeding the pace of clinical trials by making the system"scientifically driven, not lawyer- driven, not bureaucrat-driven."
One method of expediting new drug testing, he said, was forcompanies to agree to post bonds "to pay for any lawsuits, anydamages" that arise after their drugs are on the market.
He did not speculate on how the cost of the bond would bedetermined.
Said Gingrich, "My guess is you cut the time [of clinical trials] bytwo-thirds and the price by at least one-half and public safety is infact improved and you're getting better products quicker . . . you'resaving more lives."
The leader of the GOP-controlled House added, "The FDA, byextending the time span and increasing the cost of introduction [ofdrugs] has actually led to more deaths than they have saved."
The "last big scare" concerning drug safety was 30 years ago,"Gingrich said, referring to thalidomide, a morning sickness drug forpregnant women that caused birth defects in the 1960s.
Gingrich's remarks were videotaped last week in Washington inresponse to questions posed by BIO President Carl Feldbaum andKirk Raab, CEO of South San Francisco-based Genentech Inc. andchairman of BIO's board of directors.
The interview was played at the opening plenarysession of the trade organization's Ninth International BiotechnologyMeeting and Exhibition in San Francisco. The four-day conference,which has attracted about 2,000 participants, ends Thursday.
Gingrich said recent rejection of funds for construction of a new FDAcampus-like complex was an indication significant changes were inthe offing for the agency.
"That was a major policy decision designed to send a signal that wewere really serious about creating a much thinner, smaller FDA andgoing to a much different world market-oriented, information-age model of regulation," he said
The Republicans aren't the only ones proposing FDA reform. Rep.Ronald Wyden (D-Ore.), the ranking Democrat on the Housecommerce subcommittee that is holding hearings on the agency, alsohas proposed changes. The subcommittee, chaired by Joseph Barton(R-Texas), is slated to resume hearings Thursday.
Josh Kardon, Wyden's chief of staff, said Monday that thecongressman's legislation will be introduced later this week.
"It's blueprint for rational radical reform," Kardon said. One majorproposal is streamlining the premarket approval process in favor ofpost-approval monitoring.
In dealing with breakthrough drugs, he said, "a single well-designedclinical trial showing efficacy and safety" would be enough to applyfor FDA approval. Currently multiple trials are required.
"The objective," Kardon said, "is to improve the environment fordrug and device manufacturers to get products to market whilemaintaining a level of safety for consumers."
Gingrich said FDA regulatory reform was only one of severalmeasures in the GOP's strategy of making it easier for biotechnologyand pharmaceutical companies to market drugs.
Three other areas where Republicans show their sympathy tobusiness interests, Gingrich said, are extension of research anddevelopment tax credits, changes in product liability laws andreduction of the capital gains tax.
"If we lower the cost of litigation," he said, "if we lower the cost ofregulation, if we continue or improve the tax credit for research anddevelopment, and if we put ourselves in a position where we can getaccess to venture capital easier . . . it seems to me those are prettygood steps in the right direction."
Gingrich encouraged biotechnology company executives "to developa vision of where we ought to be in 30 years and then communicatethat vision everywhere."
He added that "1995, '96 and '97 could be a time of enormoustransition, but we need the right vision and the right language toexplain where you want to go and why." n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.