At the annual FDA/CMS Summit in December, senior managers from the Center for Drug Evaluation and Research outlined some of CDER’s priorities, accomplishments, and initiatives in 2012. Here are highlights of the presentations.
- The implementation of the FDA Safety and Innovation Act (FDASIA). This law impacts a wide range of CDER activities, including:
- User fee programs – The user fee program for prescription drugs was reauthorized under the Prescription Drug User Fee Act (PDUFA V), and new user fee programs for generic drugs (GDUFA), and biosimilars (BsUFA) were established.
- “Breakthrough therapies” – The development and review of drugs with this designation can be expedited.
- The Generating Antibiotic Incentives Now (GAIN) act – This initiative will provide incentives to encourage the development of new antibiotic drugs.
- Increased patient participation in the drug development process - This includes expanded efforts to obtain and incorporate patient perspective in the development of new drugs.
- Progress continued on the Sentinel Initiative, a national electronic system that expands FDA’s ability to track the safety of drugs, biologics, and medical devices once they reach the market
- Targeted initiatives to address critical public health issues were conducted, particularly in the areas of drug shortages and opioid misuse and abuse.
- For new drug reviews through November 2012:
- CDER met or exceeded almost all PDUFA application review goals.
- 31* novel drugs, also called new molecular entities (NMEs), were approved, the highest total since 2004.
- Four out of 5 of these NMEs were first approved in the U.S., which continues to lead the world in first approvals of new drugs
(*The presentation noted that 31 NMEs had been approved at the end of Fiscal Year 2012; by the end of the calendar year that number increased to 39.)
- CDER initiated new PDUFA/FDASIA programs to expedite the development of breakthrough therapies and enhance communication and efficiency during drug development and review.
- Work continued on the Risk Evaluation and Mitigation Strategy (REMS) Integration Initiative. This initiative will develop:
- criteria for determining when a REMS is required
- strategies for designing REMS that can be efficiently integrated into the healthcare system
- an evidence-base approach to measuring the effectiveness of REMS
(For more details, see the slides dated 12/10/2012 of speakers Douglas Throckmorton, M.D., Gerald DalPan, M.D., M.H.S., and John Jenkins, M.D. in the CDER Presentations Library.)