> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Court Backs FDA in PMRS Opioid Drug Case
- URL: https://www.fdaweb.com/court-backs-fda-in-pmrs-opioid-drug-case/
- Published: 2020-05-12T12:00:00.000Z
- Updated: 2026-09-14T16:14:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146771

The Court of Appeals for the DC Circuit has rejected Pharmaceutical Manufacturing Research Services’ (PMRS) request for a review of FDA decisions rejecting the company’s NDA for a prescription opioid drug and denying the company a hearing. The court [concluded](https://www.cadc.uscourts.gov/internet/opinions.nsf/2D001746BF6BB2D58525855B004FAB17/$file/18-1335-1840830.pdf?ref=fdaweb.com) that the FDA decision to deny the PMRS application “was reasonable and consistent with law and that its decision to deny PMRS request for a hearing was not an abuse of discretion.”

The court found that a complete response letter issued by FDA to PMRS identified numerous deficiencies in the NDA that would bar approval under governing law. Most importantly, it said, FDA said it could not conclude based on the evidence that the company’s drug had the abuse-deterrent properties described in the proposed label.

“Rather than attempt to remedy these deficiencies and resubmit its NDA, PMRS requested a hearing regarding approval of its application,” the court said. The decision says the company did not submit additional evidence to support the label’s statements concerning the drug’s physical and chemical properties. “Instead,” the decision says, “the company insisted that its product carried less potential for abuse because it would be indicated only for acute, rather than long-term, pain management, and because the label would recommend a maximum daily dosage that was lower than similar opioids already on the market.”

Although the company ultimately proposed adding a statement to the label that the product’s abuse-deterrent properties have not been proven, FDA refused to consider such revisions made months after PMRS requested a hearing and also said the proposal did not adequately address its concerns because PMRS still wanted to include “ADF” (for abuse-deterrent formulation” in the product name.

The court says PMRS challenged the NDA denial on two grounds — a false or misleading label is not a sufficient statutory ground on which to deny an application and that denying the application based on the draft label was arbitrary and capricious and contrary to law. It then explains why each challenge fails.