Class Action and Product Insights for Your Business
June 15, 2016 - FDA, Drug & Medical Device

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the rule in its current form.

The rule, originally proposed in 2013, directly responds to the holding in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). There, the Supreme Court held that federal law preempts certain failure-to-warn claims against generic drug manufacturers because generic labels cannot deviate from their brand-name equivalents. Consumer groups felt this was an unjust result. In many cases it left those injured by generic drugs without any remedy.

In order to address what the Supreme Court labeled the “unfortunate hand that federal drug regulation has dealt” to generic drug users, the FDA’s proposed rule would allow generic drug manufacturers to update product warnings with new safety information, even if the revised labeling differs from the branded labeling. This would drastically change the pharmaceutical landscape, as currently only brand-name drug makers can revise warning labels without prior FDA approval. While the proposed rule would “permit” generic drug manufacturers to update their labels, in reality such a change would constitute a requirement due to the likely liability implications should a generic drug manufacturer fail to do so.

This latest delay follows on the heels of recent congressional action directed toward the proposed rule. In April, the House Appropriations Committee introduced a congressional spending bill for 2017 that creates a serious roadblock for the proposed rule. The bill states that no funds will be made available to the FDA to finalize or implement the proposed rule unless the final version requires prior FDA approval for any change to a generic drug label. Clearly, members of the predominately Republican House Appropriations Committee agree with those industry groups and companies who have expressed grave concerns over the rule as currently drafted. Those who disagree with the proposed rule believe it would cause confusion and jeopardize patient safety due to the potential for conflicting labels. Requiring prior FDA approval would ensure consistency while still requiring generic manufacturers to maintain responsibility for safety warnings.

On May 18, the FDA issued a notice that the date of publication of the rule has been extended until April 2017. This is the third delay since the FDA originally proposed the rule in 2013.[1] An FDA spokeswoman commented that the extension reflects “ongoing work” but was not more specific. While the FDA has not commented on the spending bill, it seems highly likely that the latest delay is directly related and that the rule will be revised before it is finalized. We will continue to monitor future progress and provide updates accordingly.


[1] FDA Proposed Rule in Flux?; $4 Billion Price Tag for Pleasing Plaintiffs’ Bar? New Study Estimates Costs of FDA’s Proposed Rule on Generic Drug Labeling; Goodbye to Generic Preemption? FDA Publishes Proposed Rule.