WASHINGTON — The Food and Drug Administration is issuing a proposed rule that would allow generic drug manufacturers to independently update and distribute product labeling, just as brand name manufacturers are permitted to do now.
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“All drug manufacturers are required to keep close tabs on their drugs once they go to market, reviewing all reports of adverse events involving their drug and reporting these findings to the FDA,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in an FDA Voice blog post.
“But currently, only brand name manufacturers are able to independently update and promptly distribute revised drug safety information, also called labeling and they can distribute that information before FDA has reviewed or approved the change.”
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Allowing generic companies to revise drug safety information more expeditiously would be significant since generic companies are responsible for over 80% of the prescription drugs dispensed to patients.
“Empowering drug companies to update their own drug safety information is intended to provide them the incentive to more actively participate with FDA in ensuring the timeliness, accuracy and completeness of this information,” Woodcock said.
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