SAN FRANCISCO _ Biotechnology representatives, disheartenedby a lack of investor confidence and a string of clinical trial failures,are directing their frustrations at the FDA, complaining that outdatedregulations are suffocating companies.

Herbert Boyer _ who launched the industry and Genentech Inc. inthe 1970s when he developed recombinant DNA technology _ said,"I see so much good research and discoveries, the frustration comesfrom not getting those discoveries to the market. The frustrationcomes from the regulatory process."

Boyer, who was a professor at the University of California at SanFrancisco when he made his landmark discoveries, echoed a majortheme of the annual meeting of the Biotechnology IndustryOrganization.

"The regulatory process is out-of-date," he said. "It's not designed tofit into modern industry. Reform will be one of the major challengesin the next 10 years."

Boyer joined two other pioneers of biotechnology, George Rathman,formerly of Amgen Inc., and Edward Penhoet, Chiron Corp.'s CEO,in assessing the industry's prospects for the next century.

Rathman, who now heads ICOS Corp., in Seattle, said biotechnologycompanies face many of the same challenges they did in the earlydays 20 years ago.

"There's still uncertain financing, chronic disease is still a problem,"he said, and in 1993 uncured diseases cost $503 billion to treat. Asfor the FDA, Rathman said, "We have to change how products areapproved."

Penhoet sounded a more optimistic tone on the FDA. The agency, hesaid, "understands biotechnology better than it used to."

For those worried about financing, he observed, "There never hasbeen a time when capital was raining on people. The industry ismarked by major swings in capital."

The Ninth International Biotechnology Meeting and Exhibition endedits four-day run in San Francisco Thursday.

BIO President Carl Feldbaum said, "The FDA had lapsed intoinstitutional somnolence. It is now awakened and it doesn't quiteknow what to do with itself. We have some ideas."

Among BIO's proposals for changes in the FDA are two measuresthe trade group hopes will be enacted by Congress before the end ofthe year: eliminate the need for a separate regulatory approval formanufacturing and allow companies to export drugs to countrieswhere the products are cleared for marketing even though the FDAhas not approved them.

"We have been pulling the political right to the center and thepolitical left has moved hard toward the center," Feldbaum said,referring to BIO's lobbying efforts of Congress in favor of FDAreform.

"My concern is that by the end of this year [before the 1996presidential campaigns heat up] we leave the table having won somesubstantial chips."

Feldbaum, who said the BIO conference attracted more than 2,700people and was the largest to date, described the biotechnologyindustry as having entered Phase III in its development.

The first phase was in the early 1980s "when the industry generated aburst of confidence and optimism" that biotechnology would conquerall ills. That manic state eventually gave way to a depressed secondphase, he said, as people discovered the science was difficult toapply.

"Now in Phase III, people see the reality," Feldbaum said. "It's notall great or all terrible. No one's asking what's wrong. They knowwhat's wrong and they're adapting."

Boyer, the earliest architect of the industry, said that in the next 10years biotechnology will make significant progress in "elucidation ofthe pathological mechanisms" underlying heart disease and cancer.He also expects scientists will develop a better understanding ofgrowth factors, cell stimulators and immune stimulators.

"Gene therapy is one of the most interesting [research areas]," Boyerobserved, "and one of the most challenging."

Another exciting research target is the mystery of the aging process,he said, adding that in the late 1960s hardly any work was directed atunderstanding it, but now significant progress is being made.

"Although it may have a longer pay-off than 10 years, the research[on aging] is promising," he noted. n

-- Charles Craig

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

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