PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 07, 2007)
BREAK IN TRANSCRIPT
Mr. SPECTER. Would the Senator yield for a question? My office has also been in contact with FDA on this issue of bioequivalence for a life-saving antibiotic because leading infectious disease experts in my state have expressed concern that FDA did not take appropriate steps to establish this new standard for demonstrating bioequivalence. I would like to work with my colleagues on this important issue as well.
Mr. HATCH. I thank the Senator from Pennsylvania and I know that he has been in communication with FDA regarding this issue. His contributions to this dialog have been considerable. I look forward to working with him, Senator Cochran and my HELP Committee colleagues in getting some answers from the FDA on this situation.