Alert March 30, 2015

FDA Holds Public Hearing On Proposed Label Change Rule


On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the proposed rule focused on perceived public safety concerns, while opponents raised competing safety concerns and challenged the FDA’s authority under the Hatch-Waxman Act to adopt the rule. Both sides devoted attention to an alternative rule proposed jointly by leading brand and generic pharmaceutical trade associations. The comment period on the proposed rule closes on April 27, 2015.

On March 27, 2015, the FDA held a public meeting regarding its November 2013 proposed rule that would allow ANDA holders to update their product labels for safety reasons via the CBE-0 process, in advance of the reference listed drug manufacturer doing so. The FDA stressed that it would not further extend the current April 27, 2015 deadline for comments on the proposed rule.

At the meeting, approximately 40 speakers presented their respective positions on the proposed rule to a panel of FDA representatives. The speakers included pharmaceutical company representatives (brand and generic), trade association representatives, economists, politicians, medical professionals and students, attorneys, professors, and individual stakeholders.

The meeting focused in large part on the alternative general labeling rule proposed jointly by the Generic Pharmaceutical Association (GPhA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). Under this alternative rule, titled “Expedited Agency Review (‘EAR’) Post the First Generic Entrant,” either a NDA holder or an ANDA holder may request that the FDA assess new safety information on an expedited basis, and the FDA itself may initiate this assessment based on its data. The FDA then reviews the data, confers with manufacturers, and determines whether a label change is necessary and appropriate. If the FDA decides to mandate a label change, NDA and ANDA holders must implement the change within 30 days (unless the FDA decides a more expedited change is warranted).

The rule proposed by the FDA in November 2013, titled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” would allow an ANDA holder to use the CBE-0 process to implement a safety-related labeling change for its drug unilaterally, prior to the FDA approving the label change.

Those opposing the FDA’s proposed rule, as written, focused on the rule’s potential detrimental impact on consumer safety and questioned whether the agency would be acting within its legal authority to permit generic drug labeling to differ from brand labeling. Presenters stressed that the rule will impair patient safety by requiring generic drug manufacturers to propose label changes despite not having full access to safety data, confuse healthcare providers and consumers by permitting multiple differing warnings for the same drug, and negatively impact both the affordability and availability of generic drugs, all outcomes the EAR is designed to prevent. The Hatch-Waxman Act requires generic drug labeling to be the same as that approved by the FDA for the brand drug, and the FDA’s proposed rule would permit deviation.

Those speaking in favor of the FDA’s proposed rule included Public Citizen, several individuals sponsored by the American Association for Justice, attorneys representing plaintiffs in product liability suits, and others. These presenters expressed their belief that the FDA’s rule would advance safety by providing more incentives for generic drug companies to propose labeling updates, including by increasing civil liability for generic drug companies.

The meeting format provided limited time for panel questions. FDA panelist comments and questions focused largely on the economic consequences of the FDA’s proposed rule.

In its original form, the proposed rule represents an unprecedented position by the FDA, allowing generic manufacturers’ to make label changes unilaterally. Based on the tenor of the March 27 meeting, the FDA seems intent on moving forward with finalizing some version of its proposed rule. If the final rule that emerges is similar in significant part to the proposed rule, it will likely be subject to legal challenges insofar as it conflicts with the statutory mandates of the Hatch-Waxman Act. Final action by the FDA on the rule is expected by September 2015.

Because the comment period will close on April 27, 2015 with no further extensions, generic pharmaceutical companies should consult with experienced counsel as soon as possible regarding the submission of additional comments prior to the deadline. The economic impact of the proposed rule is one area as to which comments may be valuable, as the FDA meeting panelists appeared concerned with the issues of costs of compliance with the rule, augmented exposure to product liability lawsuits, and increased insurance premiums.

Carla Rose Karp ( contributed to the preparation of this alert.