## Facts

- Dr. H. Ray Evers operated the Ra-Mar Clinic in Montgomery, Alabama and administered a prescription drug that had moved in interstate commerce.
- The United States alleged Evers promoted and used the drug for a non-FDA-approved (off-label) indication.
- The government contended the drug became misbranded because its labeling lacked “adequate directions for use” for the promoted, unapproved indication, invoking 21 U.S.C. §§ 331(k) and 352(f)(1).
- Evers administered the drug only to his own patients in his clinic and did not distribute or sell it to other physicians or to the general public.
- The district court found Evers did not provide adequate patient directions for the intended off-label use but entered judgment for Evers on the theory that the conduct fell within the practice of medicine and outside the FDCA’s reach.
- The United States appealed.

## Issues

1. Whether a physician who administers a prescription drug solely to his own patients, without distributing it to others, can violate 21 U.S.C. § 331(k) by “misbranding” the drug under 21 U.S.C. § 352(f)(1) based on a lack of patient-level “adequate directions for use” for an off-label indication.
2. How FDA regulations implementing “adequate directions for use” for prescription drugs affect a misbranding theory premised on missing directions to lay patients.
3. Whether off-label promotion within a physician–patient setting, without relabeling or distribution, is sufficient to establish misbranding under § 331(k).

## Decision

- The Fifth Circuit affirmed the judgment for Evers, but on narrower statutory grounds than the district court.
- The court held the government failed to establish a violation of 21 U.S.C. § 331(k) because it did not show Evers’s conduct resulted in the drug being misbranded within the meaning of 21 U.S.C. § 352(f)(1) as applied to prescription drugs.
- The court declined to decide the broader “practice of medicine” or constitutional rationale relied upon by the district court.

## Legal Principles

- Liability under 21 U.S.C. § 331(k) requires an act with respect to a drug held for sale after interstate shipment that results in the drug being “misbranded.”
- For prescription drugs, FDA regulations treat lay “adequate directions for use” as generally impracticable and instead focus on labeling that provides adequate information for use by physicians.
- When a physician administers a prescription drug only to the physician’s own patients and does not distribute or relabel it for sale to others, failure to provide written patient directions for an off-label use, standing alone, does not establish misbranding under 21 U.S.C. § 352(f)(1) for purposes of § 331(k).
- Promotional statements tied to a physician’s administration to personal patients, without a labeling/distribution-based misbranding showing required by the statute and regulations, are insufficient to prove a § 331(k) violation on this theory.

## Conclusion

The Fifth Circuit held that the government did not prove FDCA misbranding under § 331(k) where a physician used and promoted a prescription drug off-label only in treating the physician’s own patients, because the “adequate directions for use” concept for prescription drugs operates through physician-oriented labeling requirements rather than patient-level directions.


United States v. Evers, 643 F.2d 1043 (5th Cir. 1981)