WASHINGTON -- The Food and Drug Administration onWednesday said it will immediately begin to streamline thedrug approval process, using reforms developed by thePresident's Council on Competitiveness.
The recommendations, announced jointly on Wednesday by thetop government officials from the Council, the Department ofHealth and Human Services and the FDA, promised a projected45 percent reduction in approval time by 1994 for therapiesagainst life-threatening diseases, and a 25 percent reductionfor all other drugs.
The plans include use of non-FDA contractors to review drugs,adoption of rules that accelerate the approval process --including greater use of surrogate markers in clinical trials --harmonizing drug approvals with foreign countries, andmanagement improvements at the FDA.
"All the reforms are good ideas," FDA Commissioner Dr. DavidKessler told BioWorld. "We are ready to do certain ones now.Others will take some time. We need to give 'feet' to some ofthe ideas," he said, noting that some reforms will requirespecial attention to ensure speedy implementation.
Most of the reforms should be implemented within six months,when a report will be drafted to analyze their effectiveness ,said Vice President Dan Quayle, chairman of theCouncil. "We will see where we can go from there," he said. "Ifwe can do better after that, so be it. We will be open-minded."
The council predicted that the changes will cut as much as 51months off the drug approval process and save $60 million foreach new drug that qualifies for a new, accelerated approvaltrack. Other drugs would cut about $28.5 million out of a totalaverage development cost of $231 million per drug.
The reforms will save billions of dollars, Quayle said. Inaddition, he said, the reforms "will have the potential to savemillions of lives" because patients with serious and life-threatening diseases will benefit from earlier access toimportant new drugs.
The reforms include harmonizing the FDA's drug reviewstandards with those of other industrialized nations. Thedevelopment of common procedures would reduce therequirement to duplicate clinical trials in different countriesand would "speed the approval of drugs worldwide," said HHSDirector Louis Sullivan.
Last week, drug regulators from the United States, theEuropean Community and Japan announced agreement on asweeping set of guidelines for the drug approval process, saidDr. Carl Peck, director of the FDA Center for Drug Evaluationand Research. Some of the guidelines will be adoptedimmediately, and will begin to create a uniform, streamlineddrug testing procedure for the world's major industrializedcountries.
-- Kris Herbst BioWorld Washington Bureau
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