Beset by criticisms that it frequently delays the release of promising new drugs and forces up the research and development costs of pharmaceutical companies, the Food and Drug Administration is on a campaign to justify its practices. But some say the agency is fudging the data in its efforts.

The FDA has claimed that its standards do not delay consumer access to important new drugs compared to other countries -- and that U. S. consumers, in many cases, have access sooner than patients in other nations around the world.

• In fact, the FDA used only data that would support its position, looking at new drugs put on the world market between January 1990 and December 1994.
  

• Critics say that left out many drugs first introduced in Europe in the late 1980s and submitted for U. S. approval in the 1990s -- as well as drugs still on hold here since the 1980s.

Further, the FDA ignored the issue of how long it takes for each drug to clear its Byzantine approval process.

• While the FDA claims it approved tacrine -- for treating Alzheimer's patients -- before other countries, its discoverer claims it "attempted to pull the plug on our research" and delayed the drug's availability for nearly five years.

• While admitting that there are more drugs available in Britain than in the U. S., FDA claims paternalistically that none is "of major public health interest to U.S. patients."

In comparing the approval time for processing new medical device applications, the FDA performed a statistical sleight-of-hand last year, according to critics, by switching from looking at "mean approval time" to the "median approval time" which made the agency look better.

According to a General Accounting Office report, "When the mean is larger than the median ... it indicates that a group of applications required lengthy reviews."

The genuinely relevant numbers show that the rate of approvals stayed relatively constant from 1989 to 1994, while the actual number of new medical device applications submitted dropped by 50 percent -- at the same time the FDA was achieving an 80 percent hike in funding and a 20 percent increase in personnel.