Healthy Skepticism Library item: 266

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Publication type: news

Mathews .
FDA Explores Obstacles to New Drugs Agency Calls for New Research And Tools -- and Thinks It Can Help
The Wall Street Journal 2004 Mar 16

Full text:

In a new report, the Food and Drug Administration points to shortcomings that have caused a drop-off in innovative new drugs. And the agency thinks it knows who can help: itself.

In a report to be issued Tuesday, the agency will argue that the industry needs new research and tools that will lead to more efficient and successful development and testing of drugs and other medical products.

Among other areas, the FDA said the industry needs better ways to evaluate safety and to figure out at an early stage if the product is working.

One answer, according to the FDA, is new efforts by the regulatory agency itself. Building on proposals the agency has already been pushing, the report suggests that the FDA can play an “important role” because its reviewers have access to data that stretches across all companies, which they receive as part of their approval process. “We are in a unique position to identify these problems,” Janet Woodcock, acting deputy FDA commissioner for operations, said in an interview. “We are in the review process and we see what goes wrong.”

The FDA has long worked to give drug companies guidance on designing clinical trials for individual drugs as well as broad categories of drugs.

Still, if the FDA makes a major push into research aimed at speeding drug development, that could push the agency closer to a consulting and collaborative relationship with the industry it regulates. If the agency seeks funds for such efforts, any move seen as a boon to the politically unpopular drug industry will likely draw tough questions from Congress.

Dr. Woodcock said the efforts fit with the agency’s mission of improving the public health. “We think it will provide a tremendous return to the public,” she said. The report argues that partly because of the problems, drug companies are focusing on the most lucrative products while important areas such as Third World diseases and rare illnesses become “increasingly challenging.” The FDA has also argued in the past that more-efficient drug development could help rein in the rising costs of medicines.

Industry officials said they welcomed the idea. “This is a very serious attempt to deal with how they can help us improve our success rates and reduce attrition” of experimental drugs, said Tadataka Yamada, chairman of research and development at GlaxoSmithKline PLC. There are scads of consultants pitching drug makers with ideas for R&D improvement. “The unique role for FDA is that it is the audience” for the data that drug makers develop, Dr. Yamada said. “If FDA isn’t listening or doesn’t care, we get nowhere.”

The FDA “sees there’s a problem and that we have to do something about it,” said Michael Jackson, senior vice president of drug discovery at Johnson & Johnson. He believes that the technological innovations of the 1990s, such as rapid computerized screening of chemical compounds, have made it possible for industry researchers to do more science quickly. At the same time, however, the tools that made the earliest stages of drug discovery easier shifted bottlenecks to the evaluation for safety problems and effectiveness.

For instance, he said the FDA has encouraged companies to submit genetic information gathered during clinical tests of drugs that might eventually help scientists predict future drugs’ success or failure in certain populations. The FDA has also shown a willingness to reconsider the role of some expensive animal tests that rely on species larger than rats and mice, he said. These tests have only a “disappointing correlation” with the eventual experience in humans, Dr. Jackson said, yet they require a 100-fold increase in the amount of experimental medicine, a costly proposition involving significant investments in manufacturing.

The risk that FDA’s involvement in establishing common testing techniques could blunt an individual company’s edge is low, Dr. Jackson said. “The competitive advantage is in the compound you come up with. How you figure out the development of them, I think we’d all love to find a way to improve that.”

The report cites a number of specific areas where the FDA believes new methods are needed. In terms of gauging safety, the agency says, the industry needs new techniques for assessing a drug’s liver toxicity and methods to identify gene-therapy risks, among others. The report suggests that several available technologies could help, including computer modeling.

In measuring effectiveness of drugs, the FDA report says there’s a need for helpful tools such as “surrogate markers,” used to predict the effectiveness of a drug in a trial. The agency also points to several specific areas where new research could help develop technologies that could be used for drug development, including new imaging techniques.