Lack Of Authority for FDA to Evaluate Safety of Drugs After Marketing Approval

On June 8, 2005 Steven K. Galson, acting director of FDA’s Center for Drug Evaluation and Research (CDER), and Janet Woodcock, the FDA’s acting deputy commissioner of operations, told an Institute of Medicine (IOM) panel that no one federal agency has the authority to evaluate the long-term safety of prescription drugs after medications are approved by the FDA for marketing in the U.S. 

Rather, said Mr. Galson, what exists now is an "ad hoc system . . . where the responsibility [for drug safety monitoring] is shared over a lot of different agencies."

At present, the FDA’s Office of Drug Safety is responsible for overseeing the safety of prescription drugs after approved for marketing.  The on-going controversy is the amount of authority which the Office of Drug Safety has to force drug companies to conduct post-marketing drug-safety trials.  In a vague response to the issue, the FDA’s Janet Woodcock could only say "[i]t’s possible FDA has the authority", but that is not clear.

This IOM panel was commissioned by the FDA to assess regulatory authority of the agency’s Center for Drug Evaluation and Research (CDER), as well as the CDER’s available resources and its organizational structure.  Ultimately, the IOM committee is to provide advice to the FDA on how to fix the problems that have plagued the agency’s drug-safety system over the past year.

Bill Vaughan, senior policy analyst for Consumers Union, commented that the FDA’s Office of Drug Safety "doesn’t get any respect", and that this important FDA office needs higher status, broader visibility, more resources, and stronger legal authority.

The Office of Drug Safety, asserted Mr. Vaughn, should have the clear legal authority and power to mandate warning label changes, to impose monetary penalties on drug companies that violate the FDA’s advertising regulations, and to "require, not beg," drug companies to conduct post-marketing safety trials and comparative drug studies.

"The [IOM] committee should evaluate the culture at the FDA and where the FDA has authority but maybe hasn’t been using it for the public safety," Vaughan said.

Mr. Vaughn concluded his remarks by urging the IOM committee to support legislation introduced in April by Senators Charles Grassley (R-Iowa) and Christopher Dodd (D-Connecticut) that would create an office responsible for drug safety that is independent of the FDA regulators who initially approve drugs for marketing.

The drug companies and, somewhat surprisingly, a few top drug regulators have condemned the Grassley-Dodd bill, calling that legislation a misguided attempt to create a new bureaucratic structure segregated from the rest of CDER that would impede the agency’s efforts to improve its drug safety system.

Alan Goldhammer, associate vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA), argued to the IOM committee that "FDA’s current legal authorities over drug safety are robust and do not need to be changed."

The IOM committee’s report to the FDA is not due until July 2006.

(Posted by: Tom Lamb)