WASHINGTON — Food and Drug Administration officials said they have started several new initiatives in response to the Institute of Medicine's call to overhaul drug safety efforts. The projects, including one to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.
In a September 2006 report lambasting FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.
“Five years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.
The FDA's Center for Drug Evaluation and Research has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.
The FDA also plans to publish on its Web site up-to-date information on a drug's postmarketing experience.
In addition, the IOM report urged Congress to give the FDA greater enforcement powers to compel pharmaceutical manufacturers to fulfill commitments to gather postmarketing data.
Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington, said FDA had all the enforcement power it needed already; however, it does need more funding outside of the user fees it collects.
Critics have said the FDA is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.
She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004.
In the fiscal 2006 report to Congress, 63% of those studies had not been started, she said.