News
04/09/1992

<TITLE>New initiatives to Speed Access to New Drugs</TITLE>
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P92-10                                    Food and Drug Administration
FOR IMMEDIATE RELEASE                     Eva Kemper -- (301) 443-3285 

    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 Vice President 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,"       
Secretary 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.
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                                            Page 2, P92-10, Drug Approval
    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," Dr. 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, 
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                                            Page 3, P92-10, Drug Approval
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," Dr. 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.
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