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FDA seeks authority to dictate pharmaceutical label changes
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WASHINGTON – The Food and Drug Administration has requested from Congress the authority to dictate labeling changes to pharmaceutical companies, according to the Associated Press.
The FDA hopes thereby to eliminate delays in implementing warnings, according to an AP report.
Sandra Kweder, MD, the deputy director of the FDA’s Office of New Drugs, said that after the adverse cardiovascular side effects of the COX-2 inhibitor Vioxx (rofecoxib, Merck) became known, the FDA and the drug manufacturer spent time negotiating how to phrase an appropriate warning to the public, according to the AP. Dr. Kweder told Congress that negotiating rather than unilaterally enforcing a labeling change delayed public dissemination of the risks of that drug, the AP reported.
In other legislative news, pharmaceutical and drug device companies would be required to report clinical trial information in a public database if legislation introduced in the Senate is passed. Companies that failed to comply could be subject to fines of up to $10,000 a day.