On the recordJuly 12, 2017
I thank the gentleman for yielding time and for his leadership on the committee. Mr. Speaker, I rise in strong support of H.R. 2430, the FDA Reauthorization Act of 2017, which reauthorizes the FDA's user fee programs that are critical to drug development, the medical device approval process, and, most importantly, to the patients who will benefit from these advances. While I support this critical bill overall, I want to highlight, in particular, sections 503 through 505, which is the RACE for Children Act that my friend Mike McCaul, Congressman Mike McCaul, and I introduced earlier this year. Scientific advances have shown that some childhood and adult cancers share the same molecular targets. RACE, Mr. Speaker, will help facilitate the expeditious development of innovative and promising treatments for children living with cancer by providing the FDA new authority to require a pediatric investigation into an adult cancer drug if that drug uses molecular targeting and is relevant to the cancer. I am grateful to Mr. Walden and Ranking Member Pallone and their respective staffs for understanding the urgent need to enact the RACE for Children Act and for working with me, working with my staff, to see that it was included. I would also like to highlight section 701 and 702, which is the text of a bill I introduced with Dr. Bucshon to modernize and streamline FDA's medical device inspection process by moving to a risk-based inspection approach.…
