By: Janet Woodcock, M.D.
FDA is taking a step today that is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients.
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 FDA.
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. These updates, which are submitted in changes being effected supplements, ensure that this important safety information gets to the public as quickly as possible.
Right now generic companies, who are responsible for over 80% of the prescription drugs dispensed to patients, aren’t able to revise their drug safety information as quickly as the brand name. They must provide supporting information to FDA, which then determines whether safety information for both the brand and generic drugs should be revised before updates can occur.
Today, FDA is issuing a proposed rule that would allow generic drug manufacturers to independently update and promptly distribute revised product labeling — just like brand name manufacturers – before FDA reviews or approves the change.
Empowering generic 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.
The brand manufacturer would be expected to consider the information provided by the generic drug manufacturer as part of its review and evaluation of adverse drug experience information for its drug.
And to make sure that the drug safety information updates from both generic and brand name companies are readily available to health care professionals and the public, FDA plans to post these updates on its website.
Faster safety updates and easier access to this information should be a win–win for all involved.
Janet Woodcock, M.D., is director of FDA’s Center for Drug Evaluation and Research