By Lisa Seachrist

Washington Editor

WASHINGTON - The biotechnology revolution is changing the face of medicine. At the same time, the explosive growth in knowledge of biology and its application to produce new medicines challenges the FDA to keep up with innovation.

Those challenges served as the focus for regulators who gathered at the agency's science forum this year. Addressing the forum, Amgen Inc.'s chairman and CEO, Gordon Binder, highlighted the common aims of industry and the agency in attempting to harness the potential of this emerging industry.

"Much has been said about the differing interests of industry and the agency," Binder said. "But we are all working to get these new therapies to the market. We need to look at how industry and the agency can forge a solid relationship to achieve our goals."

The two groups have already taken steps toward that goal with the passage of the FDA Modernization Act (FDAMA) in November 1997. "One year after its passage, people still like it," Binder said. "It's really quite remarkable."

Binder credited former acting FDA commissioner Michael Friedman with bringing out the best in the parties involved in negotiating the bill, and establishing an atmosphere of respect and trust between the agency and industry. Binder also praised newly confirmed FDA commissioner Jane Henney for clearly stating her commitment to implementing FDAMA and strengthening the scientific base at the agency.

"All of us in industry and the FDA have this sense of mission," Binder said. "We are on the verge of developing a whole new class of drugs. All of this innovation is bringing new challenges in regulation."

Advisory Panel System 'Needs To Be Rethought'

To achieve the mission, Binder said, the agency could take several additional steps to streamline the drug development process even further. First, he called on the FDA to revamp its advisory board system.

"The advisory board system needs to be rethought," Binder said. "In most other countries, outside experts are contacted more than they are here in the U.S. To some degree, that speaks to the tremendous expertise at FDA, but there is a place for more consultation with outside experts."

Binder suggested that advisory panels be made stronger and that they meet more often, in order to allow the agency to get feedback on their concerns about drug and biologics applications in a timely manner. In addition, he said that too many issues are brought before the advisory committees.

"Why have a meeting when the agency has already decided to approve the drug?" Binder asked. "The agency too often seeks ratification of its decisions. Instead, the agency should use the advisory panels to evaluate specific concerns about an application."

Calling upon the spirit of cooperation that permeated FDAMA negotiations, Binder urged the agency to work with industry during the implementation process.

"The FDA has already implemented many aspects of the legislation," Binder said. "In fact, the agency got started before FDAMA actually passed, and hasn't stopped yet. But we need to be sure we have dialogue on the new technologies."

Binder said industry has an active role to play in any such dialogue, and advocated that industry open up its facilities to the agency as a means of training FDA staff about new technology, as Amgen did.

"We should provide the agency staff with more opportunities for education through formal and informal training programs," Binder said.

The medicines that biotechnology will deliver over the next several years offer the promise of new ways to treat diseases, and FDAMA provides the means of getting these therapies to patients in a more timely fashion by streamlining the approval process and providing for fast-track approvals. Binder noted that, in attacking disease at its biological basis, new medicines will produce unwanted side effects for a certain number of people who use them. However, he urged the agency to strive for the right balance between risks and benefits of a drug.

"Nothing in life is totally safe," Binder said. "Airplanes crash, cars break down, hurricanes destroy homes, and medicines produce side effects. Too much regulation is as much a danger as too little."

If the agency raises the safety bar from the high standard it already occupies, Binder said, the costs for drug development could skyrocket to a point that diseases affecting a smaller number of people could be priced out of the market. n

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