Political Quotes

“I rise today to add my voice to the bipartisan support for the Food and Drug Administration Safety and Innovation Act, S. 3187. In addition to continuing the fee-based funding system for timely FDA reviews, S. 3187 also calls for strengthening early scientific dialogue and transparency, promotion of innovation through enhanced communications, and modernization of regulatory science. These provisions, including enhancing dialog between the FDA and medical device, pharmaceutical, generic and biotechnology companies early in their new product development cycle, will facilitate a clearer understanding of the specific criteria the FDA will require in its review process and provide a succinct roadmap for successful product approval. The ultimate goal is to reduce misunderstandings and expensive superfluous testing, with the hope of reducing the time and costs to bring new medical technologies safely to patients in need. I want to commend the chairman of the HELP committee, my friend Senator Harkin, and the ranking member, Senator Enzi, who worked to find bipartisan consensus on these provisions. By creating a more user friendly and accessible FDA, innovative U.S. companies built on the principle of American ingenuity, will be attracted and encouraged to develop new medical devices, technologies and pharmaceuticals.…”