Background
Vanda Pharmaceuticals markets Hetlioz, a tasimelteon drug used to treat Non-24-Hour-Sleep-Wake Disorder, which predominantly affects people with visual impairments. Hetlioz’s bottle displays the brand name “Hetlioz” and dosage “20 mg” in braille and directs pharmacists not to cover the braille and to dispense the drug in its original container. The FDA permitted, but did not require, those features.
When Teva Pharmaceuticals sought approval for generic tasimelteon, its proposed label omitted the braille and related pharmacy instructions. The FDA approved Teva’s abbreviated new drug application, reasoning that the omissions were permissible changes attributable to the products’ different manufacturers. Vanda challenged that approval and the FDA’s denial of its citizen petition, but the district court granted summary judgment to the FDA and Teva.
The Court’s Holding
The D.C. Circuit held that the Food, Drug, and Cosmetic Act’s exception for labeling changes “required” because drugs have different manufacturers covers necessary or mandatory changes, not every voluntary and safety-neutral variation. Teva had to omit the trademarked name “Hetlioz” in both roman script and braille, and it did not have to add “tasimelteon” in braille because Vanda’s approved label does not display that established name in braille.
But neither the FDA nor Teva showed that the change in manufacturers required removal of “20 mg” in braille or the related pharmacy instructions. The FDA therefore could not justify those omissions under the different-manufacturer exception. The court nevertheless remanded without vacating Teva’s approval because the FDA may determine that the labels remain “the same as” each other under the statute’s baseline sameness requirement despite the braille-related differences, and withdrawing the generic could disrupt patients and providers.
The court otherwise affirmed summary judgment for the FDA and Teva. It rejected Vanda’s conditions-of-use theory because the pharmacy instructions rise or fall with whether braille is required, and it rejected Vanda’s arbitrary-and-capricious challenges, concluding that the FDA adequately addressed safety, consistency, and prior-agency-position concerns.
Key Takeaways
- A generic-label change falls within the different-manufacturer exception only when the change is necessary because the products have different manufacturers; being voluntary and safety-neutral is insufficient.
- Teva was required to remove the trademarked “Hetlioz” name but was not shown to be required to remove the braille dosage or associated pharmacy instructions.
- Teva’s approval remains effective while the FDA considers on remand whether its braille-free label is nonetheless “the same as” the Hetlioz label within the meaning of the statute.
Why It Matters
The decision narrows the FDA’s ability to use the different-manufacturer exception to approve variations between brand-name and generic drug labels. Labeling differences must be necessitated by the change in manufacturer rather than merely optional and safe.
At the same time, the court left open whether the statutory term “same as” permits minor, safety-neutral differences in formatting, typography, script, or presentation. The FDA’s resolution of that question on remand may affect labeling practices across the generic-drug industry.