Background
Vanda Pharmaceuticals markets Hetlioz, whose established name is tasimelteon, to treat Non-24-Hour-Sleep-Wake Disorder, a condition prevalent among totally blind individuals. The FDA-approved Hetlioz bottle displays the brand name “Hetlioz” and dosage “20 mg” in braille and instructs pharmacists, in roman script, “Do not cover Braille” and “Dispense in original container.” The FDA did not require braille for safety or efficacy; Vanda proposed it voluntarily, conducted a comprehension study involving 22 braille readers, and added the dispensing instructions at the agency’s recommendation.
Teva Pharmaceuticals obtained FDA approval to market generic tasimelteon with labeling that omitted the braille and related pharmacy instructions. Vanda challenged the approval and the FDA’s denial of its citizen petition under the Administrative Procedure Act, arguing that Teva’s label violated the Hatch-Waxman Act’s requirement that generic labeling be “the same as” the listed drug’s labeling, subject to changes “required” because the drugs have different manufacturers. The district court granted summary judgment to the FDA and Teva, reasoning that the omitted voluntary features fell within that exception and rejecting Vanda’s other statutory and arbitrary-and-capricious claims.
The Court’s Holding
The D.C. Circuit held that the different-manufacturer exception permits only labeling changes necessitated by the change in manufacturers, not every optional, safety-neutral variation. Teva was required to remove the trademarked name “Hetlioz” in both roman script and braille, and it was not required to replace that name with “tasimelteon” in braille because Vanda’s own label does not display tasimelteon in braille. But neither the FDA nor Teva identified anything about the change in manufacturers that required removing “20 mg” in braille or the associated instructions. The FDA therefore acted contrary to law insofar as it approved those omissions under the different-manufacturer exception.
The court did not decide whether Teva’s braille-free label nevertheless satisfies the statute’s baseline requirement that it be “the same as” the Hetlioz label. It vacated the district court’s judgment on the different-manufacturer issue and directed a remand to the FDA without vacating Teva’s approval, allowing the agency to decide whether “same” permits the omission of optional braille as a minor, safety-neutral labeling variation. The court otherwise affirmed, including the rejection of Vanda’s arbitrary-and-capricious claims, because the FDA reasonably concluded on the record that omitting braille presented no demonstrated safety or efficacy concern.
Key Takeaways
- A generic-label change falls within the different-manufacturer exception only when the change in manufacturers makes that labeling difference necessary; an optional and safety-neutral difference is not enough.
- Teva could omit the trademarked “Hetlioz” name, but the different-manufacturer exception did not justify removing “20 mg” in braille or the related pharmacy instructions.
- Teva’s approval remains in effect while the FDA considers whether its label is still “the same as” the Hetlioz label despite omitting braille and the associated instructions.
Why It Matters
The decision narrows the FDA’s ability to rely on the Hatch-Waxman Act’s different-manufacturer exception when approving labeling variations for generic drugs. The agency must identify why a change in manufacturer necessitates a particular difference, rather than treating voluntary or safety-neutral features as freely removable under that exception.
The court nevertheless left the FDA room to conclude that labels need not be literally identical to be statutorily “the same.” Its use of remand without vacatur also preserves Teva’s market approval while the agency addresses that unresolved question, avoiding the potential disruption of withdrawing a drug over a labeling issue not shown to create safety or efficacy risks.