Before the PDUFA was passed in 1992, the average wait time for the FDA to review a new drug application was 31.3 months. And this is after about 5 years of clinical trials.

It was in response to criticism from patients, physicians, and pharmaceutical companies about these lengthy delays in the FDA's new drug application reviews that prompted Congress to pass the PDUFA. Since passage of the Act, the average review time has decreased to 10 months for standard drugs (and 6 or less months for critical drugs). User fees now make up about 65% of the FDA's costs of reviewing new drug applications.

The user fees aren't cheap. In 2008, a new drug application with clinical trial data was $1.2 million.

Is this the best way to handle new drug reviews? Given our current economic climate, it is hard to image any change in the near (or even middling) future.

Tremorgrrrl