US Institute of Medicine calls for major changes at FDA

The US Institute of Medicine last week called for fundamental changes to the country's Food and Drug Administration to improve drug safety. Its report says that the agency should be funded better and that a greater emphasis on post-marketing surveillance is needed.

The report also calls for the FDA's culture and management and its system of funding to be changed. Some of the agency's income comes from user fees paid by drug companies.

It says, “Recent drug safety events have called into question FDA's regulatory decision making and oversight processes, and caused the public to question its ability to accomplish a balanced evaluation of safety and efficacy of the drugs it reviews …