Earlier this month, Representatives Cliff Stearns (R-FL) and Ed Towns (D-NY), both members of the Energy and Commerce Committee, introduced the Faster Access to Specialized Treatments (FAST) Act, legislation intended to speed to market new drugs for people facing serious or life-threatening diseases.
The bill, H.R. 4132 – which includes nearly the same accelerated approval provisions as the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, which Senator Kay Hagan (D-NC) introduced in the Senate in February – would update and codify the Food and Drug Administration’s 20-year-old “accelerated approval” process for getting a broader range of medications to market. Originally, the FDA created this process in order to increase the availability of drugs for patients afflicted with HIV, AIDS and cancer. In order to get the product to market, drug makers have to demonstrate the product’s effectiveness by reaching certain benchmarks (like reducing the size of a patient’s tumor), and then supporting that finding with a full-scale clinical study released after the medicines were on the market.
In introducing the bill, Stearns and Towns said that the process FDA uses to bring these drugs to market is far too slow and that their legislation will modernize and streamline the process. It is widely believed that the FAST Act will be a key component of the reauthorization of the Prescription Drug User Fee Act (“PDUFA”) which is expected to be passed into law later this year.