FDA Withdraws Proposed Rule on Generic Label Changes

Regulatory NewsRegulatory News | 13 December 2018 |  By 

The US Food and Drug Administration (FDA) on Thursday withdrew a proposed rule on label changes for generic drugs after concerns were raised by commenters and FDA resources were considered.

The proposed rule from 2013 would have allowed abbreviated new drug application (ANDA) holders for generic drugs to independently update and promptly distribute revised product labeling to reflect newly acquired safety-related information, even if the revised labeling may temporarily differ from that of the corresponding reference listed, or brand name, drug.

According to FDA, the rule was intended to improve communication of newly acquired drug safety information to healthcare providers and the public.

In March 2015, FDA held a meeting to discuss the proposed rule and hear stakeholder comments, in addition to the written comments received. FDA notes that some expressed concern that temporary labeling differences between generic drugs and for the corresponding brand name drug could complicate healthcare decision making.

Others raised policy, legal liability and cost questions.

“A number of comments asserted that generic drug application holders do not generally receive or possess all the data necessary to evaluate postmarket safety information and to support safety-related labeling changes,” FDA said.

The generic drug industry group, the Association for Accessible Medicines, called for the proposed rule to be scrapped and said in 2017 that it could increase generic drug costs by $4 billion annually.

Other commenters noted that that additional or different generic drug warnings, even if temporary, “may undermine confidence in generic drugs and their therapeutic equivalence to the brand drug. Comments throughout the healthcare delivery system also expressed concern about the confusion that might result if there were different versions of safety labeling for multiple generic versions of the same drug.”

FDA Commissioner Scott Gottlieb and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock said in a statement: “We don’t want to take an action that may play a part in these unintended adverse consequences, including a risk that generic drug manufacturers would raise prices to consumers to absorb the cost of the new regulation, especially when there may be other more efficient ways to achieve the same public health goals.”

Moving forward, FDA said it is continuing to consider ways to improve the communication of newly acquired drug safety information to healthcare professionals and the public, and to facilitate efforts to keep drug product labeling up to date throughout the product lifecycle. The agency has already spear-headed an initiative to begin updating outdated generic chemotherapy labels.

FDA also noted that the current regulations already require drug and generic manufacturers to take steps to update their product labels when new information becomes available that causes the label to become inaccurate, false or misleading. 

But an area of potential concern is when brand name drugs come off the market and generic versions of those drugs remain on the market and their labels become frozen in time. By FDA’s estimate, there are about 5,600 reference listed drugs that correspond to generic medicines, but the agency also said that of these reference drugs, 1,170 have been identified as discontinued or withdrawn by the brand name drug manufacturers for reasons other than safety or effectiveness. 

Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products


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