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CORRECTED: FDA Commissioner: Action Plans for Shortening Approvals, Sharing Pharmaco Data, Are Coming

Note: This article has been corrected from a previous version, which incorrectly stated that McClellan aims to reduce approval time for priority applications to 30 days, and standard application approval time to two months. GenomeWeb regrets the error.


BOSTON, Aug. 12 (GenomeWeb News) - FDA Commissioner Mark McClellan told drug industry executives this morning that the agency will soon release an action plan aimed at bringing together the best biomedicine with risk management and economic science to "give the public bang for the buck in the areas we regulate."


McClellan's remarks came during the keynote address at IBC's 8th Annual Drug Discovery Technology Congress, which has attracted some 6,000 pharma sector researchers, executives, and others to Massachusetts- the state that McClellan said is responsible for 80 percent of the discoveries in the current new drug pipeline

McClellan said the agency wants to "do our part to help developers" submit new drug applications that contain the information they need to get approved quickly. He emphasized a new focus on "improving the drug development process to make it less risky, more certain, and less time consuming." By 2005 he said he aims to reduce by 30 days the average total review time for priority applications. For standard applications, McClellan said companies should be able to get approval two months earlier than they previously have.


To achieve this, McClellan, who was appointed last year, said he will foster earlier communications between drug developers and the FDA in order to give companies feedback that will help reduce review times. And, though he left out specifics, McClellan said he would set up programs to enable pharma companies and the FDA to share data gleaned from pharmacogenomics technologies such as microarrays.


The picture McClellan painted of the modern drug development process was a discouraging one.  Delayed FDA review times are to blame for only 10 percent of the time, start to finish, that it takes to get a drug to market, he said. In 2002 FDA approved 21 new molecular entities - less than half the number approved in 1996. New device approvals were also down, he said, attributing both numbers to an overall decline in applications. Since 1995, pharma research spending has doubled, he said, citing the current annual worldwide level at $54 billion.


With nods to developments in genomics, proteomics, systems biology, biomarkers, and information technology, McClellan said he is seeing more novel drugs and more genomics-based drugs entering late stage development, but that the industry needs to speed things up. "We can't wait 10 to 15 years for the payoff," he said. He hopes that FDA's new action plan, to be unveiled "shortly," will offer guidance that can help industry increase value, avoid delays, and trim costs.





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