US pharma could benefit from FDA delays

In an unusual case of bureaucratic delay favoring some businesses, the US CNN news agency reports that "big pharma" could benefit to the tune of billions of dollars because of the Food and Drug Administration's backlog of applications for generic drugs.

By 2011, an estimated $100.0 billion of branded drugs by sales value are due to face patent expiration. However, because of delays in processing applications from potential generic drug manufacturers, some branded products may not face immediate competition from lower-priced drugs. According to the Virginia-headquartered Generic Pharmaceutial Association (GPhA), generic applications to the FDA have rocketed 36% in the past 12 months, leaving the regulators with about 800 cases to review. Andrea Hofleich, a GPhA spokesperson, told CNN that, "over the next few years, it's really going to be a problem, as more drugs go off patent."