Orrin Hatch: “One concern that I raised, which we all agreed would have been included in the conference report language had we filed…”

“One concern that I raised, which we all agreed would have been included in the conference report language had we filed such a report was a clarification about the meaning of ``scientific or regulatory issues.'' It was our agreement during negotiations on FDARA about what is perhaps an obvious point: if the law requires a delay in approval of an ANDA or 505(b)(2) application, for example because of a patent or an exclusivity, this new provision will not change that required legal result. The law is the law, and its effect should not depend on whether or not it was brought up in a petition to FDA. I would appreciate the chairman clarifying if that was the agreement we had.”