Regulatory Focus™ > News Articles > FDA Reopens Debate Over Major Generic Drug Labeling Rule

FDA Reopens Debate Over Major Generic Drug Labeling Rule

Posted 17 February 2015 | By Alexander Gaffney, RAC

FDA Reopens Debate Over Major Generic Drug Labeling Rule

Despite rumors of its demise, the US Food and Drug Administration’s (FDA) controversial plan to allow generic drug companies to update their labels to reflect new and emerging safety information isn’t dead—not yet, at least.


As Regulatory Focus has extensively reported in the past, FDA has long been interested in making it easier for all drug companies—not just innovative manufacturers—to update the safety labeling on drug products.

Read our Regulatory Explainer on the regulation of generic drug labeling here.

At present, federal regulations prohibit a generic drug product from bearing any labeling not also borne by the product it references (i.e. the product to which it is generic).

In theory, this is meant to ensure a generic drug is not seen as more (or less) safe or effective than its innovative product.

In practice, however, this has resulted in some negative effects. For example, some generic drug companies have been unable to update their labels to reflect new adverse events, as either the brand-name drug manufacturer has failed to push for an update, or sometimes because the owner of the reference listed drug (RLD) no longer exists.

In response, FDA unveiled a new proposed rule in November 2013, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.

The rule would permit a sponsor of a generic drug to immediately issue a labeling change for any safety-related change, starting a process intended to allow differences to exist between the generic drug, the RLD and other approved generic drugs on a "temporary basis."

The labeling change application to FDA would need to contain information such as the basis for the labeling change and available data to support the change, such as adverse event data, published literature or epidemiologic studies.


Since the release of FDA’s proposed rule, the agency has encountered significant pushback.

Generic drug companies strongly oppose the rule, and have said it could open them up to billions of dollars in annual legal liabilities and increased pharmacovigilance monitoring costs. Various legislators have called into question the legality of the proposed rule, saying the Hatch-Waxman Act of 1984 does not permit the agency to authorize differences in labeling.

For a complete breakdown of the reaction to FDA’s proposed rule, please see the section “How Has the Pharmaceutical Industry Reacted to FDA's Proposed Labeling Rule?” of our Regulatory Explainer.

While FDA has steadfastly defended both its right to and reasons for promulgating the proposed rule, it nevertheless announced in December 2014 that it would delay finalizing the rule until 2015, which some industry watchers interpreted as FDA’s attempt to quietly table the rule.

New Comment PeriodOpens

But the proposed rule isn’t dead, and might just be preparing to emerge in a different form.

In a Federal Register notice published on 17 February 2015, FDA said it was reopening the comment period for the proposed regulation in light of both the significant amount of interest in FDA’s proposal and the emergence of alternate proposals put forth and endorsed by the generic pharmaceutical industry.

Such proposals might allow FDA to still accomplish its policy goal of providing additional safety information, but would have the added benefit of avoiding litigation by the generic pharmaceutical industry against FDA over the rule.

A Meeting and MoreTime to Comment

The agency, it said, plans to soon “hold a public meeting at which any stakeholders may present or comment on the proposed rule or any alternative proposals intended to improve communication of important newly acquired drug safety information to health care professionals and the public.”

In addition to the public meeting, FDA said the comment period on the proposed rule will open again from 18 February through 27 April 2015. Comments may focus on either FDA’s proposed rule or “alternative proposals presented during the public meeting,” the agency said.


Federal Register Notice


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