The Food and Drug Administration has become a founding partner in an industry-funded institute that will research and recommend procedures for speeding pharmaceuticals to the market.
Formation of the Product Quality Research Institute was announced last week by the American Association of Pharmaceutical Scientists (AAPS), a 9,000-member organization of professionals that will administer the institute.
A primary goal of the nonprofit institute will be to reduce the number of tests that drug companies are required to conduct for the FDA to ensure the quality of their products. The industry has long complained that these tests, which follow years of study required to prove the safety and usefulness of drugs, take too long and are often unnecessary.
FDA officials called formation of the institute a "win-win-win" opportunity for the drug industry, the government and the public. The institute is expected to provide the agency with valuable data and recommendations to streamline the drug-approval process, officials said, though they stressed the FDA will be free to accept or reject the institute's findings.
"We did not do this lightly--there was oversight from the highest levels of the agency," said Roger Williams, deputy director of the FDA's Center for Drug Evaluation and Research.
"We have no intention of stepping back from our job of assuring quality products. But we know we sometimes ask for more testing than is needed, and this collaboration will help us with the information we need so we can lighten up the regulatory burden," Williams said.
Since Republicans gained control of Congress in 1992, the FDA has been under intense pressure to speed up drug approvals, to make its procedures more industry-friendly and to trim its budget.
Larry Augsburger, president of AAPS and a member of the new institute's steering committee, said it is modeled on an FDA-industry-university collaboration at the University of Maryland.
In a major study funded by the FDA earlier in the decade, Augsburger and his team at Maryland worked with the agency and industry to analyze technical aspects regarding how drug quality is assured in the manufacturing process. In the process, he said, they identified many costly procedures that could be safely eliminated. The FDA agreed, and the drug industry is estimated to have saved $70 million as a result.
Augsburger said the institute was a logical extension of the University of Maryland research, although it will be privately rather than publicly funded. "We would not be looking for financial support from the industry if we had the federal money," he said. "But times are different now, and we cannot support the external research without outside sources."
The structure and goals of the institute were criticized by Sidney M. Wolfe of the Public Citizen Health Research Group, a consumer advocate on drug safety issues. He called it part of an ongoing process of privatizing important FDA functions--of "turning the chicken coop over to the fox."
"I don't trust the institute, which needs to be open more to the public," he said. "The work it's proposing should be done under the aegis of FDA and should be funded by the public, not industry. Their agenda here is to gain greater control of the process."
Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, said creation of the institute is part of a process through which the FDA has become more industry-friendly.
"Increasingly, the FDA seems to see its role as helping industry get drugs to the market as quickly as possible," he said. "People talk about how the FDA has become the world's largest regulatory consultant."
Kaitin said some industry complaints are valid regarding burdensome testing and regulation when small changes are proposed about how a drug will be manufactured.
"This is an area where the system is working well now from the public's perspective, and the quality of drugs is very high," he said. "The question posed by the new institute is whether that quality can be maintained while the process is speeded up, and it probably can."
According to Augsburger, the institute, which will work out of AAPS offices in Alexandria at first, will be governed by a board of directors exclusively from industry. Scientific issues will be researched and evaluated in technical panels, and then referred to the steering committee for a vote on whether to make a recommendation to the FDA.
Augsburger said the steering committee is made up of the institute's founding members including AAPS, FDA and six industry associations. The first president of the committee will be Tobias Massa of Eli Lilly and Co., who represents the Pharmaceutical Research and Manufacturers of America.
CAPTION: Getting new drugs to market sooner is goal of company-funded research.