Congress Passes Generic Drug Act

On July 9, 2012, Congress passed the Generic Drug User Fee Act (GDUFA) in an effort to get generic drugs to market in a timely manner. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry’s history.

As a result of a growing generic drug market, applications for new products have increased, causing a backlog of pending applications. The user fees collected by the generic drug industry will provide FDA with the funds it needs to process new drug applications and meet review deadlines established under the law.

Based on an agreement between FDA and representatives of the generic drug industry, the Act builds on the Prescription Drug User Fee Act program, which has streamlined the premarket program. According to FDA’s website, GDUFA “will enhance global supply chain safety by requiring that generic drug facilities and sites around the world use a self-identification process to include the source of all materials used in the manufacturing of generic drugs.”