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Pharmaceuticals / Regulatory Affairs / Postmarket Safety

FDA Delays Publication of Generic Labeling Rule to Fall 2015

Nov. 25, 2014

In a temporary win for generics manufacturers, the FDA says it will delay its controversial generic drug labeling rule by nine months while it reviews 119 comments it received about the measure.
It’s unclear whether the delay suggests a significant revamp or permanent defeat for the rule, which has been vehemently opposed by the generics industry.

The rule would allow generic drugmakers to update their labeling to reflect new safety information in advance of FDA review, a power only brand manufacturers have. Critics, including GPhA, have claimed it would open up the generics industry to failure-to-warn product liability suits that it is now sheltered from.

The agency had planned to publish the final rule next month. It now is expected in September 2015. FDA spokesman Stephen King said that the delay is a result of the unexpected volume of comments the rule received.

In addition to opposition from the generic drug industry, members of Congress have raised questions about the rule. They argue giving generic makers the authority to update labeling could result in different warning labels for the same drug.

GPhA did not have a comment on the publication delay. Patient safety advocates, however, were disappointed. Advocacy group Public Citizen criticized the nine-month delay, noting that the rule will improve drug safety.

“The sooner generic drug companies are allowed to make safety updates to labeling, the better for public health,” Allison Zieve, Public Citizen’s general counsel said. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.