WASHINGTON -- The Institute of Medicine has taken the FDA to the woodshed with a scathing report issued today that found the agency had lost credibility in its regulation of the pharmaceutical industry.
WASHINGTON, Sept. 22 -- The Institute of Medicine has taken the FDA to the woodshed with a scathing report issued today that found the agency had lost credibility in its regulation of the pharmaceutical industry.
The IOM report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, was drafted at the behest of the FDA and the Department of Health and Human Services.
It called for the restoration of the "appropriate balance between the FDA's dual goals of speeding access to innovative drugs and ensuring drug safety over the product's life-cycle." Among the reforms proposed by the IOM was a reevaluation of new drugs five years after approval, made on the basis of post-marketing studies.
"The FDA needs increased enforcement authority and better enforcement tools directed at drug sponsors, which should include fines, injunctions, and withdrawal of drug approval." the report said.
The IOM report also proposed that the FDA commissioner be appointed to a six-year term, a way of resolving the pervasive perception that politics intrude on science in decision-making, The appointment would still be made by the President, subject to the advice and consent of the Senate.
Moreover, the IOM recommended that a President could only fire an FDA commissioner for "reasons of inefficiency, neglect of duty, or malfeasance in office."
In all, the committee made 25 recommendations to improve FDA operations from the earliest stage of clinical trials through post-market surveillance.
Among those recommendations:
In a statement released with the report, the IOM said its committee found: