The Food and Drug Administration (FDA) has had a system for about 13 years that allows companies to get life-saving drugs to patients quickly. This system has been deemed “broken” by a U.S. representative.
“Although some companies do complete their required studies without any intervention from the FDA, the FDA has allowed many companies to stall or forgo completion of their required post-marketing confirmatory studies,” says Massachusetts Democratic Representative Edward Markey. “It now appears that the system of accelerated approval is broken and failing to ensure patient safety.”
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.
”It was supposed to be a system of approve today and prove tomorrow. But it’s become a system of approve today, but no further proof needed,” said Markey.
Though the FDA’s plan was to improve its tracking system, the organization admitted that the system is flawed. A couple of years ago, the FDA published figures showing that 349 studies for chemical-based drugs were completed, but only 61% of 1,339 outstanding studies had not even begun.
Chris is a staff writer for murdok. Visit murdok for the latest ebusiness news.
