Political Quotes

“today we will be considering and are considering a vital piece of legislation that not only includes all four user fee agreements but also includes policy proposals to improve the Food and Drug Administration review and approval of medical products, particularly in the pharmaceutical supply chain. In 2008, when Senator Kennedy was still in the Senate, he and I introduced the Drug and Device Accountability Act. This legislation was largely in response to the extensive oversight I conducted on the Food and Drug Administration. During these investigations, I identified serious problems at the FDA that included severe weaknesses in the inspection process, delays in informing the public of emerging safety problems, and lack of enforcement authority. Based on these findings, the Kennedy-Grassley legislation included provisions to ensure the safety of drugs, including foreign- manufactured drugs. It would have expanded FDA's authority to inspect foreign manufacturers and importers on a risk-based schedule. It would have required all manufacturers to register with the agency so they can properly identify the number of manufacturers and where they are located. This would have ensured that when a crisis occurs, we can quickly locate the questionable facility. And it would have increased civil and criminal penalties with respect to violations. Unfortunately, Senator Kennedy and I never had an opportunity to debate this legislation, let alone cast a vote on it.…”