ANSWERS
01/16/1996

<TITLE> FDA 1995 APPROVALS SHOW CONTINUED DECLINE IN REVIEW TIMES
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T96-6                                      Donald McLearn
January 16, 1996                           (301) 827-6242

   FDA 1995 APPROVALS SHOW CONTINUED DECLINE IN REVIEW TIMES 

     FDA's approval of 85 new drugs and biological products last
year was highlighted by the continuing decline in drug median
approval times, the surpassing of all 1995 goals of the user fee
program, and the approval of seven drugs for AIDS and other life-
threatening diseases in six months or less. One of these new
products, saquinavir, was approved in 97 days.
     The greatest performance gains were achieved in the number and
speed of drug approvals. The agency approved for marketing 82 drugs
-- a 32 percent increase over the 62 drugs approved in 1994 -- in
the median time of 16.5 months, 13 percent below the 19 months
required for approvals in 1994.
     Two new vaccines and one new therapeutic biological product
were among the 12 major biologics approvals last year which were
completed in the median time of 17.6 months. This approval time was
28 percent below the 1994 median approval time for biologics. 
     Twenty-eight of the drugs approved last year -- six more than
in 1994 -- were new molecular entities (NMEs), products containing
an active substance that had never before been approved for
marketing in any form in the United States.  The median approval 
                              -more-                         Page 2, T96-6, FDA Approval Review Times
time for NMEs in 1995 was 15.9 months, nine percent faster than the
17.5 months required for similar approvals in 1994.
     Fifteen drug products -- nine of them NMEs -- were in the
"priority" category reserved for medications that are expected to
have important therapeutic value. The median approval time for
these products last year was only 6 months, down sharply from 15
months in 1994.  All but two of the 15 "priority" approvals were
for drugs submitted under the user fee program. Their median
approval time was 5.9 months, substantially below the 10.4 months
it took to approve drugs in this category in 1994.
     In addition to Roche's saquinavir, the first new drug in the
protease inhibitor class for the treatment of advanced HIV
infection, noteworthy drug approvals last year included Syntex's
mycophenolate mofetil for the prevention of renal allograft
rejection; Merck's alendronate sodium for the treatment of
osteoporosis in post-menopausal women and of Paget's disease of the
bone; Glaxo-Wellcome's lamivudine, or 3TC, for use in combination
with AZT in treating AIDS and HIV infection; and Rhone Poulenc
Rorer's riluzole, the first drug for the treatment of Lou Gehrig's
disease.
                             -more-
                         Page 3, T96-6, FDA Approval Review Times
     Major biological approvals included the first vaccine to
prevent hepatitis A, manufactured by SmithKline Beecham; Merck's
live varicella virus vaccine for the prevention of chickenpox; Rh
Pharmaceuticals' Rho(D) Immune Globulin Intravenous (Human) to
suppress Rho(D) sensitization of Rh negative pregnant women and to
treat ITP, an uncommon immune bleeding disorder; and the first 
irradiated blood product for transfusion.
     FDA's performance last year was significantly enhanced by the
user fee program, which has fostered quality submissions by
industry and provided the agency's Center for Drug Evaluation and
Research (CDER) and Center for Biologics Evaluation and Research
(CBER) with necessary resources to meet the goals the agency set
for itself with the passage of the Prescription Drug User Fee Act
of 1992.
     FDA was committed in fiscal year (FY) 1995 -- which ran from
Oct. 1, 1994, through Sept. 30, 1995 -- to review within 12 months
55 percent of complete new drug and new biological product license
applications that had been submitted in FY '94. CDER and CBER
reviewed and acted upon 94 -- or 96 percent -- of 98 such
applications, thereby exceeding the user fee program targets for
FYs '96 and '97.
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