CRYSTAL CITY, Va. -- With Vice President Dan Quayle busyThursday night at the Republican national convention inHouston, the associate director of his Council onCompetitiveness stepped in to reflect on the group's views offederal involvement in biotechnology.

Those views on the government's proper roles in regulating,funding and encouraging public support of biotechnology canbe summed up as: limited, limited and none.

"As a general rule, biotechnology is most likely to prosperwithout too much government intrusion," John J. Cohrssen, thecouncil's associate director, told a dinner session of the NinthInternational Biotechnology Symposium here.

One reason for America's lead in biotechnology "is ourregulatory flexibility regarding new, biotechnology-derived,health-care products," Cohrssen said. He saluted the FDA formaintaining "oversight in a transparently consistent manner,supporting and not discouraging new-product development byits pre-market approval process."

Cohrssen's views on regulation:

-- "For biotechnology to grow, the federal regulatory roleshould remain limited," he said.

That aim becomes even more important as the biotechnologyindustry moves beyond pharmaceutical products, wherepotentially life-saving advantages can sustain the higher pricesneeded to absorb high regulatory costs, he said. "Otherbiotechnology products may not have the same ability towithstand expensive regulatory requirements."

A case in point is new plant varieties, where many smalldevelopers could be strapped to pay for extensive andexpensive regulatory testing and review, and whereconsistency among regulatory agencies is necessary, Cohrssensaid.

Quayle and the council supported a move in May to impose nospecial federal regulations over biotechnology-derived foods.

-- On federal funding:

The federally supported Human Genome project is a goodexample "of the government's proper role in fundingfundamental research," Cohrssen said. Such support "fundsresearch that offers the potential for large benefits to theeconomy as a whole, but does not provide the prospect of anadequate profit to any firm that might undertake the research."

-- On public acceptance of biotechnology:

"Some have argued that the government has a greater role topromote public acceptance of new biotechnology products,"Cohrssen said. "I would not want to bet on the success ofbiotechnology in the 21st century if industry needs to rely onthe federal government for public acceptance."

"Marketplace experience with biotechnology-related healthcare products shows that consumers choose approved productson their own," he said.

-- David Leff Science Editor

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

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