FDA Accelerated Drug Approval System Flawed

Almost 13 years after the Food and Drug Administration made it easier for companies to speed life-saving medicines to patients, US Representative Edward J. Markey says the system of accelerated drug review is ''broken" and fails to protect patients. Markey, Democrat of Malden, said he came to that conclusion after reviewing documents he requested from the FDA and the Securities and Exchange Commission detailing whether drug companies conducted required clinical trials and reported that information to shareholders. Since 1992, companies pledged to complete 91 clinical trials in exchange for the FDA's speediest drug review. Some 42 of the promised studies remain unfinished, including those for such blockbuster drugs as the cancer treatment Gleevec, Markey alleged. Twenty-one of the studies have not been started, while 18 are on or ahead of schedule, according to Markey's research. His office relied on FDA data and did not contact drug companies directly. Under legislation he expects to introduce next week, drug companies could face millions of dollars in fines if patients are harmed because tardy trials keep some health risks from being publicized. The proposed legislation would require drug companies to change the wording on labels to indicate that the safety and efficacy of conditionally approved products have not been proven.