Representative Anna Eshoo (D, CA) and the late Senator Edward Kennedy worked long and hard to write, lobby for, and pass the Biologics Price Competition and Innovation Act.
Unlike many of her congressional colleagues, Representative Eshoo has the creds to ask some tough questions of the FDA. She’s also smart enough to know the right questions to ask.
Unlike some of her fellow members who are swinging their political heft, trying to lobby the FDA on science-based questions, Ms. Eshoo is asking for clarification on the timing of a decision.
That is an appropriate and important question.
Representative Eshoo, in a letter to FDA Commissioner Hamburg asks (among other things) that the agency …
“Share with me the FDA’s timeline for the release of the draft guidance on naming and interchangeability.”
That’s a fair question from a member of Congress who deserves a prompt answer.
Observe due measure, for right timing is in all things the most important factor.