Is the FDA a broken agency?
March 4, 2009
Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis, according to the Associated Press. Some say the FDA is broken. Others, even some critics, see tentative improvements. The decline didn''t happen overnight. There''s no single cause. As the pharmaceutical and food industries went global, the FDA fell behind on inspections. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems. Internal computer systems were allowed to decay. The FDA drifted. This past year''s safety problems - homegrown and imported - illustrate the FDA''s weakness. Different products were involved in the incidents, but they shared some of the same FDA shortcomings: inspections, legal authority and technology. Although the FDA is supposed to inspect overseas plants, the pharmaceutical factory in China that made the heparin was never visited, partly because the agency confused its name with a similar name belonging to another drug factory. The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm. In the peanut butter outbreak, FDA inspectors quickly focused on a small Georgia processing plant. But they didn''t get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meanwhile, the agency had no authority to order a food recall. Congress has been pumping more money into the FDA. The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children''s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York''s health commissioner.