The Food and Drug Administration has issued a notice that they are reopening the comment period for interested parties to submit feedback on the Prescription Drug User Fee Act (PDUFA) reauthorization. This comment period pertains to the notice of public meeting published May 13, 2015 (80 FR 27323).
The Prescription Drug User Fee Act authorizes the FDA to collect user fees for the process for the review of human drugs and the current legislative authority for PDUFA expires in September 2017. At that time, new legislation will be required for the FDA to be permitted to continue collecting user fees. PDUFA’s intent is to provide revenues to the FDA so the FDA can hire additional staff, improve systems, and establish a better managed human drug review process, which will in turn make important therapies available to patients sooner without compromising review quality.
Variations of PDUFA have been around since 1992 and have made significant strides in reviewing original new human drug and biological product applications, resubmissions of original applications, and supplements to approved applications. The FDA has maintained their high standards for safety, efficacy, and quality while eliminating backlog and allowing authorized drugs on the market in an efficient manner, benefitting patients nationwide.
The FDA held a meeting on July 15, 2015, and received a wide variety of comments on a range of topics. Some of the topics discussed were: the assessment of the overall performance of PDUFA V (current PDUFA) thus far; what current features of PDUFA should be reduced or discontinued to ensure the continued efficiency and effectiveness of the human drug review process; and what new features should FDA consider adding to the program to enhance the efficiency and effectiveness of the human drug review process.
The comment period will be open until April 29, 2016 “to allow interested persons additional time to submit comments.” Interested persons may submit either electronic or written comments.
For further information, contact Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 1146, Silver Spring, MD 20993-0002, (301) 796-5003.