Kathy Castor: “This bill is a bill in search of a problem. FDA has approved 99 percent of the expanded access requests it receives.…”

“This bill is a bill in search of a problem. FDA has approved 99 percent of the expanded access requests it receives. FDA's expanded access program approves nearly all requests for investigational drugs or biologics it receives. Physicians at the FDA are available 24 hours a day to approve any emergency expanded access requests that the agency receives, and it typically grants those emergency requests immediately over the phone and nonemergency requests in a median time of 4 days and generally no longer than 30 days. FDA has also taken actions to streamline this entire process. The process of clinical trials at FDA is vital to the protection of the health of all of our neighbors and the folks we represent. In 11 percent of expanded access applications, FDA has raised a red flag and said: Do you know what? You have got to change this. That is who we are trying to protect here: the actual patients. The patient groups across the country agree with us. Many States have tinkered with right-to-try laws, but this is different. Forty States have enacted right-to-try laws, but there is no evidence that anyone has obtained the type of therapy via these laws that couldn't have been obtained through the FDA's expanded access program. Right-to-try laws do not compel companies to provide patient access to these treatments. Therefore, under these laws, patients still do not have a right to try, only the right to request it from the company.…”