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DRUG REVIEW INITIATIVES ANNOUNCED

 DRUG REVIEW INITIATIVES ANNOUNCED
 WASHINGTON, April 9 /PRNewswire/ -- Vice President Dan Quayle and


HHS Secretary Louis W. Sullivan, M.D., today announced that four initiatives are being implemented by the Food and Drug Administration to speed access to new drugs and improve the drug review process.
 "These initiatives follow through on FDA's commitment made last November, as recommended by the President's Council on Competitiveness, to provide earlier access to important new drugs, ease unnecessary regulatory burdens and strengthen U.S. competitiveness," said Quayle, who chairs the council.
 "These actions will save both lives and money and reduce human suffering. They will substantially improve FDA's ability to respond vigorously to the nation's health needs by allowing important new drugs to be approved months or even years earlier than was previously possible," Sullivan said.
 FDA Commissioner David A. Kessler, M.D., said that the changes will streamline the drug development process without sacrificing rigorous oversight. "While drug reviews will be accomplished faster, patients can be assured that only drugs that are both safe and effective will be approved," he said.
 The four initiatives reported today are:
 Accelerated Approval -- Proposed rules are being published to accelerate the approval of new "breakthrough" drugs. They will allow these therapies to be approved at the earliest time in their development at which safety and effectiveness can be reasonably established. Under these new procedures, in making an approval decision, FDA will use "surrogate endpoints" that indicate that a drug is effective and then further confirm its effectiveness through additional human studies that will be carried out after marketing approval. "We used surrogate endpoints in approving the AIDS drug DDI. DDI was approved in just months -- not years, as would normally have been the case," Kessler said.
 Under the new procedures time to approval could be reduced by as much as one to three years for "breakthrough" drugs.
 Parallel Track -- Experimental therapies will be made available to AIDS patients as early as possible in the drug development process -- a departure from the current practice of making investigational drugs available initially only through controlled clinical studies. This "parallel track" policy, an effort of the National Institutes of Health and FDA, will be published in the Federal Register this week. It will permit access to these drugs by those patients with AIDS who are unable to participate in the controlled clinical trials. The new policy, initially aimed at AIDS, may be evaluated for other serious diseases.
 Safety Testing Harmonization -- Through guidance based on consensus among the European Community, Japan and the United States, safety data based on animal testing in one of the participating countries will now be accepted by the others. This will eliminate the need to duplicate valid animal testing, and will reduce the time currently required for long-term testing by six months or more.
 "As a result, safety data developed in accordance with one country's standards will be accepted by another, and drug sponsors will no longer face the burden of performing multiple studies on new drugs to meet varying national requirements. This will cut the time and resources currently required for such testing," Kessler said.
 Outside Expert Reviews -- To reduce the backlog of new drug applications, FDA is undertaking an external review program to use qualified experts from outside the government to review certain routine types of applications. FDA has solicited a proposal for a pilot external review. A contract to manage and conduct this review is being negotiated with the MITRE Corporation. A notice appeared Friday, April 3, in Commerce Business Daily soliciting additional qualified organizations to participate in this program. Although FDA will retain final approval authority, the expert reviewers will assume much of the burden of analyzing the data in these applications.
 Both FDA and NIH are agencies of the Public Health Service within HHS.
 -0- 4/9/92
 /NOTE: Attention TV broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Eva Kemper of the Food and Drug Administration, 301-443-3285 or, after hours, 410-740-2633/ CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:


DC-SB -- DC025 -- 6838 04/09/92 13:48 EDT
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Date:Apr 9, 1992
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