Biotech industry participants and observers are cautiouslyoptimistic about biotech's future under the Clinton/Goreadministration. But they have a host of questions waiting foranswers, and numerous personal agendas.

Will a change in this country's administration -- both in theWhite House and Congress -- mean a change in its regulatorypolicies on biotechnology? What effect will a Democratic regimehave on biobusiness? Also to consider are issues surroundingagriculture and the environment, internationalcompetitiveness, technology transfer and health caremanagement. And appointments to key federal agency postsare definitely worth watching.

The vice president-elect might head the list of new officeholders who bear close scrutiny in the coming months. "Thewild card in the whole Clinton administration is Gore,"according to one prominent biotech observer. As a senator fromTennessee, Albert Gore headed the Senate's sciencesubcommittee; in fact he was known as its leading voice onscience issues. Although a key government official stated thatGore's record on biotech has been "spotty," Greg Simon, Gore'slegislative director, told BioWorld that "Gore has generally beensupportive of biotech and an outspoken (policy) leader."

Gore most recently penned his biotech policy proclivities in anarticle in the fall 1991 edition of the Harvard Journal of Lawand Technology, where he stressed that "there has been agradual rise to prominence of technology over policydevelopment."

Richard Godown, president of the Industrial BiotechnologyAssociation, said that "the vice president-elect has a substantialand published interest in bettering the environment. ... He'llrecognize the safety and benefits" of biotech's scientificadvances.

And Rebecca Goldburg of the Environmental Defense Fund, toldBioWorld that "it should be of help to biotech and to technologyin general to have a vice president who has a long-terminterest in the issues."

Yet another view comes from Peter Barton Hutt, a lawyer withthe Washington, D.C., firm of Covington & Burling and theformer chief counsel for FDA. "If asked, I'm sure Senator Gorewould say he's completely behind biotechnology, but after thatit's hopeless (in terms of discrete issues)," Hutt told BioWorld.Hutt sees legislative issues involving biotechnology asextremely complex -- "even the industry can't agree," he said.

Policy making will come from many sources, and industryobservers are keeping their eyes on whom Clinton will appointto some of the key administrative and agency positions. HenryMiller, director of FDA's office of biotechnology, told BioWorldthat "the augers for biotech will be who's appointed to theseslots: the White House science adviser, the assistant secretaryof agriculture for science and education, the assistant secretaryof agriculture for marketing and inspections, the assistantadministrator of the EPA for pesticides and toxics, the head ofthe office of information and regulatory affairs at OMB, and, toa lesser extent, the FDA commissioner and the NIH director." Ofthese, Miller said, "the most telling will be the administration'sscience guru."

Suzanne Huttner, director of the University of CaliforniaSystemwide Biotechnology Research and Education Program, isespecially concerned about appointees who will be able toinfluence research funding for universities, as well as whomight head up the National Institutes of Health and theNational Science Foundation.

Most observers are optimistic about overall administrationbiotech policy, however. "We have every reason to believe thatClinton recognizes the importance of biotechnology to the U.S.economy," IBA's Godown told BioWorld. And William Small, theAssociation of Biotechnology Companies' executive director,said he's looking forward to "the challenge and opportunity ofworking with a new administration that has a lot of quicklearning to do about the issues."

"The administration warrants every effort we can possiblyprovide to introduce them to the pathway biotech has takenover the past 12 years," said George Rathmann, chairman andchief executive officer of Icos Corp.

Some biotech analysts are slightly more cautious, however. G.Steven Burrill, national director of manufacturing and high-technology industry services for Ernst & Young, has mixedfeelings about how the change in the White House will affectbiotech companies. "The issues of health care cost containmentand prescription drug prices will probably affect companiesnegatively," Burrill said.

But some industry analysts believe the emerging focus ontechnology may result in better technology transfer --especially from federal labs -- and research funding. MishaPetkevitch, director of health care investment banking atRobertson, Stephens & Co., agreed that "there might potentiallybe controls on drug prices, but they will be looked at in theperspective of costs to the total health care system."

And Peter Drake, executive vice president and director ofequity research at Vector Securities International, toldBioWorld that he has "high hopes and low expectations,"although he does think that "all signs are positive for Clintonwanting to maintain biotech's competitiveness in the world."

-- Jennifer Van Brunt Senior Editor

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

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