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FDA Proposes New Rule Allowing Generic Drug Makers to Change Labeling

Christine Eke3 years ago

The U.S. Food and Drug Administration (FDA) has proposed a new rule that would allow generic drug manufacterers to update their labels to upon disovering risks and side-effects not reflected by current labels.

Recent History of Generic Drug Labeling

  • In 2011, the United States Supreme Court ruled that generic drug makers were not required to update product labeling, so long as the same change has not been made to the labeling for the branded medicine, even if drug makers were alerted to side effects.
  • This decision effectively shielded generic drug makers from liability over product labeling.
  • Generic drug makers had argued that they would have been required to provide labeling that is different from what appears on labeling of the brand-name drug (which is against FDA regulations), and successfully convinced the Court to rule in their favor.

FDA's Current Generic Drug Labeling Proposal

“This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use.” – Janet Woodcock, FDA Center for Drug Evaluation and Research

  • The FDA’s proposed rule will allow generic drug makers to update labeling with new safety information before an FDA review of the change; the FDA would then justify the change and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time.
  • The FDA estimates that more than 80 percent of all prescriptions filled in the U.S. are generic drugs and the agency hopes the new proposals will gaurantee that these consumers are provided with the most accurate and up-to-date information possible. 
  • Public Citizen, an advocacy group, has come out in support of the proposal, saying, “It will close a very large and unnecessary safety gap.”
  • The FDA acknowledges in the proposed rule that “there may be concerns about temporary differences in safety related labeling for drugs that the FDA has determined to be therapeutically equivalent, especially if multiple [drug application] holders submit [labelig changes]. ”
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