Lawmaker Says Drug Firms Are Abusing the Accelerated Approval Process

The FDA's accelerated approval process for drugs is "broken," contends a top Democratic representative, who says many drug companies aren't completing the postmarketing studies they pledged to conduct after gaining approval of their products.

Since the FDA's accelerated approval system was created in 1992, pharmaceutical firms have completed barely half of the postmarketing studies they promised to conduct in exchange for receiving a speedier review, according to Rep. Ed Markey (D-Mass.), whose staff recently conducted a detailed analysis of the FDA's postmarketing records. Of the 91 postmarketing studies promised by drug firms, 42 remain unfinished, according to Markey's research. Twenty-one of the studies on a total of 16 drugs have yet to be started, while 18 studies are ahead of schedule, Markey alleged.

"It's outrageous that drug companies and the FDA have been dragging their feet when it comes to conducting required postmarketing studies," Markey said in a June 1 statement. "They are laughing at the FDA, and sometimes it seems as if the FDA is treating it as a joke as well."

Among the companies Markey singled out were AstraZeneca, Novartis and Eli Lilly.

In addition to companies not completing their pledged studies, the FDA isn't living up to its responsibility to inform the public about postmarketing commitments, Markey said. The FDA has a publicly accessible database of postmarketing commitments on its website, but according to Markey's review, the site is inaccurate and incomplete. More than one-quarter of the study commitments reported on the site had discrepancies when compared to the postmarketing data provided to Markey's staff by the FDA.