Monday, April 1, 1996
WASHINGTON - President Bill Clinton on Friday announced a series of administrative actions by the FDA to speed development and approval of cancer drugs that in some respects goes beyond steps the agency has taken to accelerate the path of AIDS drugs to market.
The steps represent significant regulatory departures that may have implications beyond cancer. The FDA will take a proactive role in fostering development of drugs and ensuring that they are available to patients, including soliciting applications for U.S. approval for products approved overseas and, for the first time, taking foreign regulatory approvals into consideration.
Administration officials suggested that similar steps may be undertaken to speed development and approval of therapies for all serious and life-threatening diseases. Clinton and FDA Commissioner David Kessler compared the new actions to the accelerated approval mechanisms for AIDS drugs implemented in 1992.
Kessler told reporters at the White House that "we want very much to create the same kind of incentive, the same kind of stimulus, for the development of all drugs, not only for AIDS and cancer, but of all serious and life-threatening diseases."
Kessler also signaled a thawing of FDA's "zero risk" attitude. "We are taking some risks," he said. "One day we are going to make a mistake, but I believe that is OK, especially when we are dealing with diseases for which there are no available therapies."
The cancer drug initiative consists of four elements: accelerated approval for cancer drugs; expanded access for drugs approved in other countries; increased cancer patient representation at FDA advisory committee meetings; and less red tape for additional uses of approved cancer drugs.
Clinton said the changes, which went into effect immediately, "will cut development time for cancer drugs by as much as several years." He added that "at the same time, FDA will cut its review time of these drugs from 12 months to 6 months."
The reforms are part of Vice President Al Gore's National Performance Review or "reinventing government" initiative. Gore said the changes "will mean an end to all of the stories that we used to hear about interminable delays" in approving cancer therapies.
Following are highlights of the changes: