Sens. Charles Grassley (R-Iowa) and Edward Kennedy (D-Mass.) introduced legislation Thursday that would give the Food and Drug Administration more resources to inspect domestic and foreign-made prescription drugs and devices. President Obama has said he supports the bill.
"There are certain things only a government can do. And one of those things is ensuring that the foods we eat, and the medicines we take, are safe and do not cause us harm," Obama said in a weekly address in March, where he backed Grassley's efforts.
The Drug and Device Accountability Act of 2009 comes following FDA concerns about medical device reviews calls for an Institute of Medicine study to examine the FDA's system for approving devices. It is similar to legislation introduced last year by Grassley and Kennedy.
"An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn't know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year," Grassley said. "Our legislation is a practical solution to beefing up the FDA's inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency's work."
According to Grassley, the new bill would augment the FDA's resources through the collection of inspection fees. It would expand the FDA's authority, including new subpoena powers, for ensuring the safety of drugs and medical devices made domestically and in other countries. And, it would require certification of applications for drugs and devices needing FDA approval and establish civil and criminal penalties for false or misleading certifications.
In his floor statement Thursday, Grassley said over the last five years he has conducted extensive oversight of the FDA and has identified "serious problems," including stifled scientific opinion within the agency; delays in informing the public of emerging safety problems; too cozy of a relationship between the FDA and the industries it is supposed to regulate; and a failure to be adequately transparent and accountable to the public.
"The FDA will require strong leadership to rebuild public confidence and tackle the cultural and organizational problems that have plagued the agency," he said. "Strong leadership alone, however, will not fix all the problems. The agency needs additional tools, resources, and authorities to fulfill its mission of protecting the health and safety of the American people.'
In response to a 2007 General Accountability Office report that found FDA falling short on foreign inspections, agency officials said it doesn't have the resources to inspect the hundreds of foreign medical device and drug plants. FDA also has language barriers and logistical problems that prohibit thorough inspections overseas, they added.
In the 2007 report, GAO said FDA has the same inspection downfalls in had in 1998.
Photo by Carolyn Bunce obtained from Sen. Baucus' Web site.