The United States Congress has passed the Generic Drug User Fee Act
(GDUFA) in an attempt to get generic pharmaceutical 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. The fees will go to the US Food and Drug Administration (FDA).
As a result of a growing generic drug market, applications for new drug 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.
The new Act is the result of 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 pre-market program. According to FDA’s website
, the 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.”
The sponsor for the new act was Rep. Bobby Rush [D-IL1].
A generic drug
(“generics”) is a drug that is comparable to a branded drug in terms of dosage and performance characteristics. Such drugs are marketed under their chemical name without brand advertising. They are cheaper alternatives for consumers. An example would be generic paracetamol compared with branded Panadol.