## Facts

- A pharmaceutical manufacturer submitted a New Drug Application (NDA) for an immediate-release oxycodone product and sought labeling and a product name indicating “abuse-deterrent” characteristics.
- The asserted abuse-deterrent features focused on deterring intravenous misuse, including a coloring feature intended to make an injectable solution visually unattractive and other claimed physical/chemical barriers to extraction.
- FDA issued a Complete Response Letter denying approval, concluding the proposed labeling was false or misleading because the submitted studies did not support the represented abuse-deterrent properties.
- FDA determined the data showed oxycodone could be readily extracted to prepare an injectable solution and that the coloring feature lacked empirical support as a deterrent.
- The manufacturer did not revise the application to conform to FDA’s position and instead requested a formal evidentiary hearing.
- FDA denied the hearing request, finding no “genuine and substantial issue of fact” warranting a hearing.
- The manufacturer petitioned for judicial review, challenging both the NDA denial and the hearing denial under the Administrative Procedure Act (APA).

## Issues

1. Whether FDA acted arbitrarily or capriciously in denying the NDA on the grounds that the proposed abuse-deterrent labeling was false or misleading and not supported by substantial evidence under the governing statute.
2. Whether FDA abused its discretion by denying a formal evidentiary hearing for lack of a genuine and substantial issue of fact.

## Decision

- The court denied the petition for review.
- The court held FDA reasonably applied the statutory standards requiring substantial evidence for claimed drug effects in proposed labeling and permitting refusal where labeling is false or misleading.
- The court upheld FDA’s conclusion that the record did not support the asserted abuse-deterrent properties reflected in the proposed labeling.
- The court held FDA did not abuse its discretion in denying a hearing because the applicant’s objections were primarily disputes with FDA’s scientific and methodological judgments, not material factual conflicts.

## Legal Principles

- Under the APA’s arbitrary-and-capricious standard, courts generally defer to an expert agency’s scientific judgments when the agency considers the relevant evidence and provides a reasoned explanation connecting the record to its decision.
- FDA may refuse NDA approval when there is not substantial evidence—typically requiring adequate and well-controlled investigations—supporting the drug effect it purports to have under the conditions described in proposed labeling.
- FDA may refuse NDA approval when proposed labeling is false or misleading in any particular, including where the labeling conveys a clinical or functional property the evidence does not support.
- An applicant is not entitled to a formal evidentiary hearing absent a genuine and substantial issue of fact; disagreement with the agency’s scientific evaluation or methodology, without a material factual dispute that could change the outcome, is insufficient.

## Conclusion

The court upheld FDA’s denial of approval for an oxycodone product whose proposed “abuse-deterrent” labeling was unsupported by substantial evidence and affirmed that an evidentiary hearing is not required where the applicant raises only scientific disagreement rather than a genuine, material factual dispute.


Pharmaceutical Manufacturing Research Services, Inc. v. Food & Drug Admin., 957 F.3d 254 (D.C. Cir. 2020)