WASHINGTON _ House Minority Whip Newt Gingrich, (R-Ga.), hastargeted the FDA _ at least as it exists today _ for destruction andsaid he would rebuild an agency with scientific entrepreneurs.In a wide-ranging address at the Biotechnology Industry OrganizationFall Conference '94, Gingrich said his plan to do away with FDA is thefirst stage of a broader strategy to tear down governmental barriers toentrepreneurial innovation _ which, he said, hobble the U.S. in its bidto do business in the world marketplace.Gingrich, who is poised to become Speaker of the House shouldPresident Clinton lose his bid for re-election, described the FDA as"the leading job killer in America" with the Environmental ProtectionAgency "a close second." He did not cite any evidence to support theseclaims, and no one in the largely sympathetic audience here challengedhis contention.Jim O'Hara, an FDA spokesman, responded: "We're not familiar withthis proposal, but this country, through its elected representatives, haslong recognized the need for a science-based, consumer-safety agencysuch as the FDA. We believe that we are faithfully fulfilling thatmission mandated by Congress."Gingrich did not confine his remarks to the FDA. He also castigated theClinton administration and several members of Congress, includingRep. Henry Waxman, (D-Calif.), for the scarcity of venture capital forbiotech research.He asked the assembled scientists and CEO's to play a bigger role inpolitics, by "fighting specific fights which have a big enough payoffthat it's worth your while to learn how politics actually work, insteadof just griping about the system."We're trying to convince people who are in the high-techentrepreneurial environment that you want to think long term, just asyou do in your own companies. That you want to educate yoursuppliers, your employees, your customers and them have them putpressure on Congress," Gingrich said.Biotech entrepreneurs recognize, he said, that "we are a decayingsecond-wave industrial society trying gradually to make a transition toa third wave information society."One of your problems," Gingrich said, "is that most of the people youdeal with on a daily basis operate in an industrial-era system," whichhas not come to grips with the rapid pace of technological change orthe complexity of gaining and keeping a toehold in the high-techmarketplace.Gingrich said some federal regulatory agencies, like the FDA, areamong the worst offenders and should be dismantled. He added that heis working in tandem with a non-profit group, called the Progress forFreedom Foundation, to accomplish his goal."We are designing a project for replacing the current FDA," Gingrichsaid. "It's essential. It is possible in a three- to five-year period tounderstand and replace the model _ to understand how destructive theFDA is and communicate that to the country. We probably have abetter than even chance of literally replacing it."He said the replacement agency's goal would be to advance the causeof innovation and entrepreneurship. To that end, it would be staffedwith biomedical entrepreneurs, who would serve for five years, andthen return to business. The term-limit would accomplish anotherGingrich goal: reduce the career bureaucracy.Forrest Anthony, president of Avid Therapeutics Inc., of Philadelphia,asked during a brief question and answer period how Gingrich wouldreconcile the industry's staunch opposition to price controls with thesupport of some members for a Medicare drug benefit, which wouldmean more customers and "make us rich."Gingrich responded that, if such a proposal should become law, theindustry would essentially cede to the federal government the power toset prices and risk becoming a "public utility."Anthony said in an interview that he knew the answer before he askedthe question _ and agreed with it _ but that he wanted those in theroom that favored the drug benefit to hear it. "When governmentbecomes the only buyer of our products," he said, "it is the death ofinnovation." n
-- Steve Sternberg Special To BioWorld Today
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