CDER Prepares for Cures Act

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), explained some of the ways the 21^st Century Cures Act will influence the center’s plans, in an email to CDER staff dated Dec. 15, 2016. Woodcock states in the email that FDA is analyzing the provisions of the act to develop an implementation plan and that the drug development requirements will most likely have the most impact on CDER.

The 21^st Century Cures Act was signed into law on Dec. 13, 2016 and increases funding for the National Institutes of Health, funding for opioid abuse prevention, and provisions for medical product development. Title III of the Act, according to Woodcock, provides for “patient-focused drug development, qualification of drug development tools, continuous manufacturing of pharmaceuticals, novel clinical trial designs, use of real-world evidence in the regulatory setting, and antimicrobial drug development.” The section provides for the expansion of the Senior Biomedical Research Service and the hiring of additional FDA personnel.

“CDER leadership has been working with the Administration and Congress in providing technical assistance for many of these provisions, so they are familiar to us. A number of them reflect initiatives we have been working on for many years, such as the qualification processes. By instantiating these in statutory provisions, Congress is effectively making these part of our mission,” Woodcock stated in the email.