Madam President, today, with passage of the FDA Safety and Innovation Act and the reauthorization of the FDA user fee agreements, we have helped both the FDA and the biomedical industry ensure that they can get needed medical products to patients quickly and safely. This legislation will ensure that the FDA can swiftly approve drugs and medical devices, save biomedical industry jobs, protect patient access to new therapies, and preserve America's global leadership in biomedical innovation. It will keep patients safer by modernizing FDA's inspection process for foreign manufacturing facilities, while also improving access to new and innovative medicines and devices. It will reduce drug costs for consumers by speeding the approval of lower cost generic drugs and help prevent and address drug shortages. Finally, by improving the way FDA does business, increasing accountability and transparency, U.S. companies will be better able to innovate and compete in the global marketplace. By passing the FDA Safety and Innovation Act, we have taken an important step to improve American families' access to lifesaving drugs and medical devices. As I have said throughout this debate, the bipartisan process that produced this excellent bill has been quite remarkable. I have worked closely with my colleagues on both sides of the aisle, as well as industry stakeholders, patient groups, and consumer groups to solicit ideas and improvements on the critical provisions in this bill.…
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