As the costs of health care continues to soar, consumers are looking for ways save money. As blockbuster drugs lose their patient protection, they are being manufactured by the major generic companies like: Teva Pharmaceutical, Barr Pharmaceuticals, Mylan Laboratories, Watson Pharmaceuticals, and Novartis.
In an effort to increase the number of generic drugs available to consumers, the Food and Drug Administration (FDA) has created the program “Generic Initiative for Value and Efficiency” (GIVE). The FDA’s plan is intended to change the way generic drugs are approved and to meet the growing number of generic drug applications.
This year (2007), the FDA has already approved 30% more generic drugs than last year. That is 682 generic drugs that have been approved this year, with a backlog of 1,300 generic drug applications waiting approval…and the list is still growing.
The FDA’s program, GIVE, is suppose to ensure applications for generic drugs, that are patent free and have no exclusivity provisions, will be reviewed immediately. The goal is to make generic drugs available to consumers much quicker. As part of the GIVE program the FDA plans to increase the current review staff of 215 and to update the application submissions to an electronic format.
The Generic Pharmaceutical Association (GPA) believes that giving the initiative the title ‘GIVE’ achieves little and more resources are needed. They would like to see a rein on lobbying activities of brand-name drug makers, which often stalls approval for the generic drugs.