"FDA approved" labeling statement

Executive Summary

The American Pharmaceutical Assn. asked Sen. Hatch (R-Utah) in Aug. 20 letter for his support of an amendment to the FD&C Act that would require a drug mfr. to include the word "FDA" followed by an NDA number in Rx labeling. APhA said the term would indicate a drug had gone through the approval process but would not mislead consumers as would the term "FDA approved." The assn. maintained that "an indication of FDA approval status would constitute a governmental 'commercial' endorsement of a drug product".