WASHINGTON — Food and Drug Administration officials said in March they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts.
The projects, including a pilot project 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 that lambasted the 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, the FDA's associate director for medical policy. The Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to gather data at 1, 2, and 3 years after launch, he said. He declined to name the drugs.
The agency also plans to publish a newsletter on its Web site to provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.
The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel drug manufacturers to fulfill their commitments to gather postmarketing data.
Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington & Burling in Washington, said the agency already has all the enforcement power it needs, but that it needs more funding outside of the user fees it collects.
Critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast said those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for 2007.
In a report to Congress (fiscal 2006), 63% of postmarketing studies had not been started. The agency needs a better hammer to get those studies done, she said.