FDA Improves Drug Approval Times

December 1, 1995

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.

WASHINGTON--A new report by the General Accounting Office (GAO)shows that the Food and Drug Administration now approves drugstwice as fast as it did 6 years ago. In 1987 the FDA took an averageof 33 months to approve new drugs, while by 1992 it was takingonly 19 months.

As of 1995, approval times have dropped to an average of 13.5months for drugs approved under a new "fee" programthat allows pharmaceutical companies to help pay for additionalreviewers.

Most of the drugs in this new program are variations of existingdrugs. For new chemical compounds, the GAO study found that averageapproval time in 1994 was just 18 months, about half the timeit took in 1987.

Many groups had complained over the years about FDA's slow approvaltimes, often referred to as the "drug lag," and somehad even suggested the lag as a reason to completely overhaulor abolish the FDA.

In response to these complaints, the GAO at the request of Congressreviewed the FDA's performance, comparing it with that of theUnited Kingdom, which has often been cited as superior in approvingdrugs quickly yet safely.

The results of the study were a surprise, especially when it wasfound that approval of new chemical compounds in the United Kingdomin 1994 actually took an average of 24 months, 6 months longerthan in the United States.