Frank Pallone actually said...

I think the failure of the Department to complete security plan approvals and compliance inspections is a very serious issue.

Do you think that the Department must play a role? I mean, do you think that it is absolutely necessary that they play a role?

I welcome today's hearing and I am very much looking forward to working together on the critical business of this subcommittee.

PDUFA has been a remarkable success, giving patients access to safe, effective and breakthrough medical treatments.