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FDA Improves Drug Approval Times

FDA Improves Drug Approval Times

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 reviewers.

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.

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