WASHINGTON--A new report by the General Accounting Office (GAO)
shows that the Food and Drug Administration now approves drugs
twice as fast as it did 6 years ago. In 1987 the FDA took an average
of 33 months to approve new drugs, while by 1992 it was taking
only 19 months.
As of 1995, approval times have dropped to an average of 13.5
months for drugs approved under a new "fee" program
that allows pharmaceutical companies to help pay for additional
Most of the drugs in this new program are variations of existing
drugs. For new chemical compounds, the GAO study found that average
approval time in 1994 was just 18 months, about half the time
it took in 1987.
Many groups had complained over the years about FDA's slow approval
times, often referred to as the "drug lag," and some
had even suggested the lag as a reason to completely overhaul
or abolish the FDA.
In response to these complaints, the GAO at the request of Congress
reviewed the FDA's performance, comparing it with that of the
United Kingdom, which has often been cited as superior in approving
drugs quickly yet safely.
The results of the study were a surprise, especially when it was
found that approval of new chemical compounds in the United Kingdom
in 1994 actually took an average of 24 months, 6 months longer
than in the United States.