Political Quotes

“I rise in strong support of the underlying bill we are debating, the Food and Drug Administration Safety and Innovation Act. This legislation, which has been the model of bipartisanship and effective legislating on the part of Chairman Harkin and Ranking Member Enzi, is critically important to the people of New Jersey and the Nation. This bill is about more than drug safety. It is about more than protecting patients. It is about improving the approval process to speed access to new lifesaving, life-enhancing drugs and devices, and making sure the FDA is a partner in the production of safe and effective products. This bill does this and accomplishes several key goals that are critically important to our Nation's health care system. Not only does it reauthorize the key user fee agreements for prescription drugs and medical devices, but it establishes agreements for generic drugs and generic biologic drugs called biosimilars. Together, these user fee agreements will provide the FDA with the resources necessary to improve the drug and device approval process to more quickly and efficiently bring new products to market. It will enhance communication between manufacturers and the agency to foster a more cooperative environment, and it will allow for better and more thorough postmarket reviews to ensure continued patient safety and product efficacy. There is more to this bill than the FDA user fees.…”