The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the Food and Drug Administration authority to regulate food, drugs, and medical devices, among other products. New provisions are added from time to time—or existing ones enhanced or expanded—to enable the agency to better do its job.
Sometimes existing provisions of the law are scheduled to expire on certain dates and must be reauthorized by Congress. One such provision is the agency’s user fee program—fees paid to FDA by companies submitting new product applications. New provisions are known as amendments to the FD&C Act.
On September_27, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007, with HHS Secretary Michael Leavitt, FDA Commissioner Andrew von Eschenbach, and Rep. Joe Barton of Texas in the Oval Office.
This new law represents a very significant addition to FDA authority.
Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded. These programs will ensure that FDA staff have the additional resources needed to conduct the complex and comprehensive reviews necessary to new drugs and devices.
Two other important laws were reauthorized: the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Both of these are designed to encourage more research into, and more development of, treatments for children.
Overall, this new law will provide significant benefits for those who develop medical products, and for those who use them.