Orrin Hatch actually said...

"Is it possible for FDA to trace adverse events and identify the source without a unique identifier in the name?"

"Given the similarity between FDA's draft guidance and the World Health Organization's scheme on biologics qualifiers, it would be important to consult with a WHO in arriving at a global solution."

"There are a lot of tradeoffs in the naming convention."

"I'm very pleased with what you do over there, and I'm particularly pleased with what you're doing in this area."