Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—D.C. Cir.: Judgment in Hetlioz labeling dispute vacated in part with instructions to remand to FDA, (Aug 25, 2026)

By Justin Marcus Smith, J.D.

No one developed an argument about whether omission of Vanda’s optional addition of braille preserved “sameness” under the FDC Act.

In a dispute about the proper labeling of Teva’s generic form of tasimelteon, all parties agreed that Teva was required to omit the Vanda brand name “Hetlioz” from the Teva label in both Roman and braille script. However, the U.S. Court of Appeals for the D.C. Circuit held that Vanda failed to present any sound argument as to how statute or caselaw mandated Teva to display the established (generic) name and active ingredient “tasimelteon” in braille, especially when it did not even appear in braille on the Vanda Hetlioz label. Next, the D.C. Circuit held the different-manufacturer exception did not permit the removal of the braille “20 mg” from Teva’s label. Going beyond that holding to vacate Teva’s FDA approval for tasimelteon would have been too disruptive. The court therefore instructed the district court to remand to the FDA to decide in the first instance whether the Teva label satisfied the baseline requirement of being “the same as” the Hetlioz label under 355(j)(2)(A)(v), thereby rendering the applicability of the different-manufacturer exception irrelevant to the omission of “20 mg” in braille. The court accordingly affirmed in part and vacated in part the district court grant of summary judgment for Teva (Vanda Pharmaceuticals, Inc. v. FDA, No. 25-5041 (D.C. Cir. Aug. 18, 2026)).

Background. Vanda alleged that the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) violated the Administrative Procedure Act (APA) in approving intervenor defendant Teva’s abbreviated new drug application (ANDA) for the Teva form of tasimelteon, a generic form of Vanda’s brand-name drug Hetlioz. The drug is intended for treating “non-24,” a circadian rhythm disorder affecting the blind.

The district court found FDA officials had unanimously concluded that omitting braille would not make the Teva label unsafe, hence the FDA decision to approve the TEVA ANDA was neither unlawful, nor arbitrary, nor capricious. The omission of braille and its accompanying instructions fell within the different-manufacturer exception, and the FDA did not violate the APA. The district court accordingly denied Vanda’s motion for summary judgment and granted the Teva and FDA defendants’ motion for summary judgment (see Teva and FDA prevail on Vanda’s challenge to omission of Braille from generic labeling, Feb. 20, 2025).

On Vanda’s appeal, the U.S. Circuit Court of Appeals for the District of Columbia Circuit applied de novo review. Vanda principally challenged FDA approval of the Teva braille-free labeling as contrary to the same-labeling provision of the FDC Act. The same-labeling provision imposes a baseline rule: proposed generic drug labeling must be the same as the labeling approved for the listed drug, subject to the different-manufacturer exception. The exception applies to changes required because the new drug and the listed drug are produced or distributed by different manufacturers. 21 U.S.C. § 355(j)(2)(A)(v).

Applying the plain meaning of the different manufacturer exception to the facts, the D.C. Circuit affirmed in part that the change in manufacturer required omission of the braille “Hetlioz.” The D.C. Circuit also rejected Vanda’s argument that the FDC Act required Teva to include the established name and active ingredient “tasimelteon” in braille. It was not in braille on the Hetlioz label. The different-manufacturer exception did not, however, permit Teva to omit “20 mg” in braille or the instructions “Do not cover Braille” and “Dispense in original container” from the label.

Naming debate. Vanda pressed the argument that the established generic name tasimelteon appeared only in Roman script, not in braille, on its own label. Vanda proposed that requiring Teva’s label to include the established name in braille when it is not on the Hetlioz label would dictate difference, not sameness. However, the D.C. Circuit said Vanda did not develop argument or supply authority why the sameness requirement would require difference; did not explain why discrepant treatment of the established name would be required because Teva is a different manufacturer; and cited no law whatever requiring a generic manufacturer to display the established name differently than it appears on the name brand label.

If anything, Vanda may have revealed a potential defect in its own label in that the established or “generic” name must accompany the drug brand name each time it is featured on the label, with comparable prominence, including typography, layout, contrast, and other printing features. Vanda placed only its own brand name Hetlioz in braille, not the generic name tasimelteon.

Sameness debate. Next, the D.C. Circuit held the different-manufacturer exception did not permit the removal of the braille “20 mg” from Teva’s label. In the court’s view, Teva and the FDA “attempted to rewrite the statute by replacing ‘required’ with ‘optional and safe.” The statutory text provided otherwise.

The FDA and Teva reading turned on interpreting the definition of “require” to mean “suitable or appropriate,” but the court said the full dictionary meaning implicated a need to serve some end or purpose. In other words, even under the FDA and Teva preferred definition, a change must be more than desired, it must be necessary. The FDA and Teva did not identify any need to remove the “20 mg” in braille.

In distinguishing a case that Teva cited, the D.C. Circuit said its task after Loper Bright was to discern what Congress meant using traditional tools of statutory construction. See Loper Bright Enters. v. Raimondo, 144 S. Ct. 2244, 2262, 2266 (2024). Beyond that, all statutory language must be read in context. The relevant phrase here was “changes required * * * because” Teva was a new manufacturer.

The D.C. Circuit reasoned that the intent of Congress to make a change of manufacturer a specific exception to warrant a change of drug labeling counseled against the FDA and Teva “whatever we choose, consistent with safety” reading.

The D.C. Circuit found Teva’s remaining arguments unpersuasive. One holding the FDA and Teva cited did not require the court to interpret the scope of the different-manufacturer exception. It only rested on other statutory provisions that separately allowed generic labels to list a subset of the name-brand drug indications. A change in manufacturer likewise required the labeling change in that case.

The FDA pointed to its own regulations and past practice, but the court said it did not show that it marshaled any expertise in concluding that “required” really meant “optional unless safe.” The FDA regulations cleaved to the ordinary meaning of required as something mandatory.

Concerns that it would be aberrant to read the FDC Act as permitting safe variation in a generic drug’s substance, but not its label, were unfounded. The FDC Act does not categorically prohibit “safe variation” in a generic drug’s label. Exceptions in the same-labeling provision permitted labeling modifications needed to ensure accuracy in connection with changes to inactive ingredients or slight differences in absorption.

All parties agreed that the same-labeling provisions allow de minimis label variation in features like fonts, type size, and colors. FDA and Teva insisted that the different-manufacturer exception embraced de minimis changes. The court already held that the FDA and Teva reading of the different-manufacturer exception conflicted with the plain text because, unless legally mandated, font, color, and stylistic changes are not required because of a change in manufacturer. This highlighted that Vanda’s reading turned on what it means for a generic label to be “the same as” the name brand label. However, no one developed an argument whether a label that omits Vanda’s optional addition of braille preserved “sameness” under the FDC Act either generally or in line with a de minimis exception for things like fonts. The court concluded this was a question the FDA could tackle on remand.

The D.C. Circuit reversed the district court grant of summary judgment to Teva and the FDA as to the removal of the braille “20 mg” and the braille-specific instructions “Do not cover Braille” and “Dispense in original container. That summary judgment was contrary to law under the different-manufacturer exception.

The court declined to take the additional step that Vanda requested and vacate FDA approval of Teva’s generic. The seriousness of the deficiencies of the action and the disruptive consequences of vacatur both counseled against vacatur. First, the FDA error might be curable on remand because “same” does not necessarily mean “identical.” The FDA might determine on remand that the Hetlioz label and the braille-free Teva label are nonetheless “the same.” Second, vacating FDA approval of Teva’s tasimelteon would be very disruptive.

Use conditions. The court said the Vanda argument that Teva’s omission of the instructions “Do not cover Braille” and “Dispense in original container” violated the “conditions of use” provision under 21 U.S.C. § 355(j)(2)(A)(i) did not add anything to the mix. The FDA suggested adding these instructions only to the extent the label had braille. If “20 mg” had to appear in braille, these instructions would have to be included. If the FDA should decide on remand that the labels do not need embossed braille to be “the same,” then the instructions could be “omitted as superfluous and potentially misleading.”

No arbitrariness. Last Vanda separately contended that FDA approval of the Teva generic was arbitrary and capricious for three reasons, but the D.C. Circuit said none of the Vanda arguments succeeded. The FDA decision was fully consistent with the government’s position in a case where the Solicitor General made an amicus argument that generic drug manufacturers cannot unilaterally add safety warnings to their labels. Vanda said that interpretation was “fundamentally opposed” to the FDA position in this case, but Vanda failed to identify any departure from the position the Solicitor General articulated. Nothing in the FDA position here quibbled with the Solicitor General’s explanation that the same-labeling requirement precludes generics from unilaterally adding warnings that are not on the name-brand label. The Supreme Court ultimately read the statute the same way the Solicitor General did. The removal of braille lettering the FDA allowed, but did not require, on the Vanda Hetlioz label did not have to do with a generic drug adding or subtracting safety warnings. The whole argument here was a “tempest in a teapot” because the FDA must act according to the best reading of the statute.

FDA actions in connection with whether the inclusion of braille made the drug safer easily passed muster. Vanda’s own label did not include tasimelteon in braille either, because the FDA concluded it was not necessary for safe use of the drug. The FDA also explained why there was no safety concern. Moreover, the FDA noted Vanda’s own statistic that only 10% of the blind population actually reads braille, and other measures, like larger print, “talking bottles,” and RFID tags could enable access to labeling information for the visually impaired.

Among the court’s evaluations of other arguments here, the FDA took a consistent position because Vanda voluntarily used braille on its Hetlioz label.

The case is No. 25-5041.

Judge: Millett, P.

Attorneys: Paul Whitfield Hughes (McDermott Will & Schulte LLP) for Vanda Pharmaceuticals, Inc. David L. Peters, U.S. Department of Justice, for the U.S. Food And Drug Administration.

Companies: Vanda Pharmaceuticals, Inc.

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