Bilirakis Statement on House Passage of the FDA Reauthorization Act
Washington, D.C. – U.S. Rep. Gus Bilirakis released the following statement after today’s unanimous, bipartisan House passage of the Food and Drug Administration (FDA) Reauthorization Act, H.R. 2430.
“The FDA Reauthorization Act will bring the FDA into the 21st Century. If the United States is going to lead the world in biomedical innovation, we need an FDA that can efficiently review and approve new drugs. The FDA must act with the same urgency that patients feel while waiting for cures,” said Bilirakis. “I am especially proud that the bill includes my bipartisan provision to help spur the development of new generic drugs, increase market competition, and drive generic drug prices down.”
Specifically, Bilirakis’ provision, Title VIII of the bill, would:
• Require the FDA to prioritize the approval of generics within eight months when there are three or less approved drugs on the market,
• Create the Competitive Generic Therapies program to have the FDA work with drugmakers to improve the quality of submissions, so more applications can be approved the first time around,
• Give the FDA the tools to maintain an accurate list of the drugs that have little or no other competition, and
• Provide an incentive for drugmakers to enter markets where only one or no generic drug exists.
The FDA Reauthorization Act also includes a provision known as the RACE for Children Act, which Bilirakis co-sponsored as a standalone bill. It would support the study of promising new cancer drugs not only for adults, but for pediatric cancers as well.