FDA exploring a change in generic drug product labels updates

SILVER SPRING, Md. - The Food and Drug Administration last week announced that it is reopening the comment period for its proposed rule that would allow abbreviated new drug application holders to unilaterally update their generic drug product labels prior to the new drug application holder doing so. The comment period closes on April 27, 2015 and the FDA will also hold a public webcast on March 27, 2015 regarding its proposed rule.

 

The proposed rule, if finalized, would enable ANDA holders for generic drugs to update product labeling promptly to reflect certain types of newly acquired safety-related information, irrespective of whether the revised labeling differs from that of the corresponding reference listed drug. 

 

FDA's proposed revisions to its regulations to allow generic drug manufacturers to update product labeling in the same manner as brand drug manufacturers are intended to improve communication of important, newly acquired drug safety information to health care professionals and the public.

 

The final rule is expected in September 2015, if at all, suggested Goodwin Procter's Carla Rose Karp in a blog posted on JD Supra Business Advisor. 

 

"The FDA’s plan to reopen the comment period and hold a webcast, together with certain public comments made by FDA representatives, suggest that the final rule could end up being significantly different from the original proposal published in November 2013," Karp suggested. "The generic pharmaceutical industry has opposed the FDA’s original proposed rule as inconsistent with the requirements and purpose of the Hatch-Waxman Act. The original proposed rule would permit multiple competing labels on drugs that are chemically and biologically equivalent, likely resulting in confusion among prescribers and patients."