Recently, members of the United States House of Representatives introduced a bill which, if passed, would allow new medications and treatments for mesothelioma and other deadly diseases to reach the market much more quickly. The Faster Access to Specialized Treatments bill, or FAST Act, would update and codify the Food and Drug Administration’s “accelerated approval” process, which the lawmakers say has become much slower in recent years.
The accelerated approval process was initially developed about 20 years ago as a response to the surge of HIV, AIDS and certain deadly cancers in the U.S. The goal was to increase the availability of new treatments for these life-threatening diseases by reducing the approval burdens on medication manufacturers.
The program required drugmakers to hit only a few specified benchmarks to prove the treatments’ effectiveness before the FDA would issue its approval. They would then be required to conduct full-scale clinical trials after the drugs were released to the market.
In recent years, however, that accelerated process has been anything but. A 2009 study reportedly found that cancer drugs both in and outside of the fast-track program took about the same time – seven years – to get to the market. In fact, medication outside the accelerated program was available to the public about one month before treatment in the program.
The FAST Act, according to one of its sponsors, would modernize the FDA program “to reflect the amount of medical and scientific innovation that has occurred in the past 20 years,” enabling drug manufacturers to provide innovative and life-saving treatments to patients “at the earliest point in time.”
Source: The Gainesville Sun, “Stearns hopes to speed medicines to market,” Bill Thompson, Mar. 11, 2012