The US Food and Drug Administration has announced a new scheme which it says is aimed at “increasing the number and variety of generic drug products”.
The programme, called the Generic Initiative for Value and Efficiency (GIVE) is designed to help the FDA modernise and streamline its generic drug approval process. It gave the green light, or tentatively approved, a record of 682 generics in the fiscal year to September 30,2007, over 30% more than the previous year.
However the agency is facing a backlog of some 1,300 applications, which currently take almost a year and a half to review and Gary Buehler, director of the FDA’s Office of Generic Drugs said the GIVE plan “outlines ways to maximise the use of our resources so that FDA can review and approve even more high quality generic drugs” than it did in the last fiscal year.
Specifically, the FDA is revising the review order for certain drug applications. One example involves first generic products, for which there are no blocking patents or exclusivity protections on the reference-listed drug, are identified at the time of submission for expedited review and should in theory “reach the consumer much faster”, the agency said.
The FDA currently has 215 full-time staff working on the review of generic drug applications but under GIVE, it will be able to hire and train new staff and “focus on enhanced use of electronic programs for handling drug submissions and internal documents”. The agency concluded by saying that it will “increase its communications with generic drug manufacturers and provide training on proper application submission to the industry in meetings and webcasts”.
However the response from the USA’s Generic Pharmaceutical Association to the new plan was not as positive as the agency would have liked. Its president, Kathleen Jaeger, said that “while we all share the goal of increasing efficiency in the generic approval system, another initiative in name only simply will not get the job done”.
She added that “what consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics”, claiming that “for years, the agency has tinkered around the edges with programmes and initiatives designed to increase efficiency but have proven to yield little in the way of significant results”.