FDA being assailed by generic drug requests

United States drug regulators are being bombarded by numerous requests for generic drug approvals since the handling of such drugs has improved.

According to the U.S. News & World Report's web site, "Last year, the FDA introduced a program it calls the Generic Initiative for Value and Efficiency, or GIVE, with the hope that it would modernize and streamline the agency's generic approval process." It seems to be working since the FDA approved over 600 generic drugs in the last year but that is not enough for some, "We want to increase these numbers," Dr. Andrew C. von Eschenbach, commissioner of the U.S. Food and Drug Administration said.

Generic drugs tend to be cheaper as opposed to their brand-name counterparts. In addition, the average approval time according to the FDA averages between 16 and 17 months with the law requiring generic drugs to be processed within six months.

Gary Buehler, the director of the FDA's Office of New Drugs, said the current backing is about 1,300 applications but half of those cannot be processed because the brand-name that the generic drug is copying has not yet lose its patent protection or exclusivity. Some of the top-selling brand-name medications whose patent protection runs out in the next year include Wyeth's Effexor and Merck & Co's osteoporosis medicine Fosamax.