WASHINGTON _ The Biotechnology IndustryOrganization (BIO) has staked out a position on FDAreform that represents the interests of big biotech andpharma houses, most of which don't want to disturb theregulatory status quo. That's according to Henry Miller, a14-year veteran of the FDA who is now known by manyas an anti-regulatory zealot.

"BIO is soft on FDA reform. The association has taken aposition that is virtually identical with what theadministration is willing to give away," said Miller,founding director of FDA's office for Biotechnology in1989. (That office was later dismantled by FDACommission David Kessler.)

Last year, Miller launched a blitzkrieg of editorials atnumerous major daily newspapers criticizing the policiesof all major government agencies that regulatebiotechnology. (See BioWorld Today, Nov. 28, 1994, p.1. ) Now he has set his sights on the industry's primaryrepresentative in Washington: BIO. While there arebiotech and government critics aplenty, Miller ranks asone of the few who garners respect because of hiscredentials and grasp of biotech scientific and regulatoryissues.

Miller's critique of BIO has appeared on the editorialpages of the San Jose Mercury News and San DiegoUnion Tribune. BIO's President Carl Feldbaum has askedthe Union Tribune to publish his rebuttal.

Miller, now a fellow of scientific philosophy and publicpolicy at Stanford University's Hoover Institution,contended that BIO's FDA reform bill should have beencast as farther to the right politically so that itsconservative provisions would serve as bargaining chipsin the legislative negotiating process. "But you have towonder what's wrong when you see that Rep. RonWyden's (D-Ore.) FDA reform plan is more conservativethan what BIO has proposed. It just doesn't add up," hesaid.

The upshot is that the House Commerce Committee staffis "livid that BIO has undercut their position by writing areform bill that is far too tepid," Miller charged. "Withoutthe industry's support, the Commerce bill won't attractsufficient support in the House," Miller predicted. StaffCommerce Committee members did not return telephonecalls from BioWorld Today for an interview.

Feldbaum said BIO's bill was not an ideologicaldocument. "It's no secret that Amgen Inc. [of ThousandOaks, Calif.] took the lead in developing the bill with theadvice of 165 companies. BIO developed a functionalplan to streamline FDA regulation. The document wasnot designed to be right or left of anything. In the finalanalysis it is a moderate approach," Feldbaum toldBioWorld Today.

"What BIO should have done was embrace a positioncloser to those articulated by conservative policy thinktanks and then compromised," Miller said. He said hefailed to understand why BIO and PhRMA did notinclude a provision in their bills which would haveallowed the FDA to recognize the approval of drugs byregulatory agencies in Europe and the U.K.

Miller said he doubted if the House CommerceCommittee bill would generate support among biotechfirms but Feldbaum sharply disagreed. "BIO will bedelighted if and when the Commerce committee comesout with a bill that is more conservative than ours."

Feldbaum would not indicate whether or not BIO wouldsupport a more conservative approach.

BIO Should Take Risks

Miller said that BIO consistently takes a moderate andsafe position when it should be more aggressive inopposing unnecessary regulation. "BIO does notunderstand the negotiating process. They should lead witha position that represents far more than what theassociation expects to get. Instead, BIO takes thepolitically expedient route that is often close to thefederal government's position. Federal officialscompromise a bit and BIO declares victory when inreality it hasn't taken any risk to champion the interests ofthe biotech industry."

Many biotechnology executives were startled earlier thisyear when several conservative think tanks, such as theCato Institute and Progress and Freedom Foundation,both of Washington, put forward FDA reform plans thatfundamentally questioned many of the assumptions onwhich current U.S. drug regulation is based, such aswhether the FDA should be regulating the efficacy ofdrugs. (See BioWorld Today, Feb. 7, 1995, p. 1.)

Keep Legislation On Track, BIO Says

BIO has viewed these proposals as dangerous becausethey threatened to arm opponents of FDA reform withsufficient arguments to delay action on legislation,Feldbaum said.

"BIO is dealing with the real world where the art of thepossible determines many of our choices. We are tryingto craft a proposal that creates common ground amongthose with different views on FDA reform. We think wehave done that, "Feldbaum said.

Miller attributed much of BIO's inertia about FDAreform to resistance among the larger biotech firms andpharma houses to open up new drug development tocompetition from innovative small biotech firms.

"The big companies don't mind keeping the smallerinnovative companies jumping through regulatoryhoops." Miller said.

Miller also criticized the smaller firms for "abdicating" toAmgen and Genentech Inc., of South San Francisco, theresponsibility for making decisions about FDA reform.But he noted that many of the smaller companies havesmall regulatory affairs staff that "have no time for FDAreform," he said.

Feldbaum countered that BIO represents many of theinterests of smaller firms for the very reason that thelarger firms are represented by their own staffs inWashington. "The larger companies have a voice," hesaid.

Miller, who worked at the FDA from 1979 to 1993,predicted that the departure of former BIO Chairman KirkRaab, former chairman of Genentech, would encouragesmaller companies to show more interest in how BIO isrun. n

-- Michele L. Robinson Washington Editor

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

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