FDA to ID Research for Drug Development
Posted on: Tuesday, 14 March 2006, 18:00 CST
By ANDREW BRIDGES
WASHINGTON - Federal regulators, working with patients, academics and pharmaceutical companies, are listing dozens of potential research projects they believe would help shorten the time it takes for new drugs to reach patients.
The release this week of the Food and Drug Administration list of roughly 75 projects comes two years after the regulatory agency first announced it would identify ways of modernizing the drug development process under its so-called "critical path" initiative. The name refers to the journey a drug takes from laboratory to patient.
The FDA has said that it wants to take some of the guesswork out of the job of developing and testing drugs, as well as medical products, and make the process more predictable and less expensive. If successful, FDA officials and others hope the initiative will refill a pipeline that's slowed to a dribble.
With more than nine out of 10 experimental drugs failing when tested in humans, the number of innovative drugs reaching the market hit a 20-year nadir in 2004 - even as pharmaceutical research-and-development spending has increased, according to the FDA.
Dr. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, said Tuesday that the critical path list "will highlight areas where we think better scientific tools can continue to improve the way that new drugs are tested." His remarks were prepared for the International Good Manufacturing Practices conference at the University of Georgia College of Pharmacy in Athens.
The list being prepared focuses on two areas in particular: new scientific projects to improve how clinical trials are designed and new ways to validate methods of measuring the toxicity and efficacy of drugs.
Key to the latter effort would be the listing of biomarkers, or physical changes that can be measured in patients to assess how they respond to a drug.
In January, the FDA issued suggestions on how researchers can more efficiently evaluate the promise of new laboratory discoveries and separate out those drug candidates most likely to succeed from those doomed to fail.
The critical path program stood to receive its first funding last month, when the FDA requested $6 million for fiscal 2007.
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On the Net:
Food and Drug Administration: http://www.fda.gov
Source: Associated Press/AP Online
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