Antineoplaston clinic should be considered a manufacturer subject to federal statute -- Kessler to Rep. Barton.
Executive Summary
ANTINEOPLASTON CLINIC SHOULD BE CONSIDERED A DRUG MANUFACTURER subject to federal statute covering drug manufacturers, FDA Commissioner Kessler suggested at a second hearing on alleged FDA retaliation held by Rep. Barton's (R-Tex.) Commerce/Oversight Subcommittee Dec. 5. "There is a very big difference, in my opinion, between dealing with someone who manufactures a drug, what we call at FDA a sponsor," and someone who dispenses a drug to an individual patient faced with a life-threatening illness, Kessler said.