Political Quotes

“Because of the hard work of my colleagues on both sides of the aisle, the final bill includes new incentives intended to help spur the next generation of lifesaving antibiotics. This is a good thing, and my colleagues should be commended for their bipartisan work on this important issue. Unfortunately, the requirement for the FDA to submit a strategy and implementation plan that would have helped to ensure greater regulatory certainty and predictability regarding FDA's work with antibiotics was not included in the final bill. Yet we have all watched stories on TV about a young lady who was attacked by a virus that has eaten her hands and her feet--an infection. What does she need? She needs a breakthrough in antibiotic therapy. This was a real opportunity for us to send a message out there that not only are we committed to doing it, we are committed to setting up a regulatory structure that allows it to happen. Carefully drafted GAO reporting requirements intended to help FDA and Congress identify progress against regulatory challenges in this space have also fallen away. This had nothing to do with Richard Burr or Michael Bennet, this was the General Accounting Office. Unfortunately, the reporting requirement that remains is not nearly as robust as the language passed by the Senate earlier this year.…”