The U.S. Food and Drug Administration (FDA) fell short of the mark in meeting statutory deadlines for approving new health products in the fiscal year ending September 30, 1997, says a new report.

Until the FDA approves a new medical treatment, patients cannot use it. Critics say a review process that withholds safe and effective therapies can be just as dangerous as an unsafe drug. Thus Congress requires the FDA to approve or deny important products within specified timeframes. For instance:

• Federal law requires the FDA to act on new drug applications within 180 days, but it took the FDA an average of 651 days to act on applications approved in FY 1997 -- 55 days longer than the previous year.

• However, the 130 days on average it took the FDA to act on simple medical device applications -- called 510(k) submissions -- was 10 days less than it took in FY 1996, though it still missed the 90-day statutory deadline by an average of 40 days.

• And for new medical devices -- those not "substantially equivalent" to ones in use before 1976 -- it only took the FDA 497 days on average to give 48 premarket approvals, compared to 786 days the year before; thus it missed the 180-day deadline by an average of about 10 months.

These figures include only drugs and medical devices approved for the uses requested by manufacturers. Some applications are still pending, and since the time delays are only averages, some approvals took much longer.