On Thursday, July 28, the Senate Committee on Health, Education, Labor, and Pensions held a hearing to discuss the upcoming PDUFA and MDUFA reauthorizations. Margaret Hamburg, Commissioner of the FDA, was the witness featured during the hearing. The opening statements made by the Chair and Ranking Member emphasized the importance of user fees and the consequences if they are not reauthorized.
During her opening statement, Hamburg summarized her detailed 30-page written testimony outlining the history and challenges to PDUFA and MDUFA, as well as actions the FDA has taken to address some of the more substantial problems facing the medical device approval process, particularly delays in approval time. Hamburg mentioned during her oral testimony that the FDA and industry share responsibility for these delays, and the FDA has identified and is working to fix several of the issues they found during an internal review of the medical device process. She acknowledged later in the hearing that some of the delays medical device manufacturers in particular face are actually a result of reviewers inappropriately stopping reviews to request unnecessary information, which was the driving force behind a recent reviewer training program.
A great deal of the question and answer period focused on issues of innovation, globalization, and the comparison of U.S. and European approval processes and review times. Hamburg was also asked by Chairman Harkin about regulatory science at the FDA. She noted that the current system is not adequately harnessing advancements in science, and if a new era of personalized medicine is going to be ushered in anytime soon, a strong regulatory science framework is crucial to keeping up with the influx of new drugs that could come as a result. She was also questioned as to their feeling about the IOM report to be released July 29, 2011, with recommendations regarding the 510k process. Hamburg said she does not know what the report will say, but said the FDA will take the recommendations into consideration and any policy changes that may come as a result of the IOM report will be transparent and open to public comment.
Hamburg repeated throughout the hearing that the she feels the reauthorization of both PDUFA and MDUFA provide great opportunities to make significant strides and changes to the process to make it more consistent and streamlined for industry and the FDA.
Senator Burr was very critical of the effectiveness of PDUFA and repeatedly grilled Hamburg about supposed changes made to statutory language passed in FDAMA without Congressional approval; threatened to delay reauthorization if the proposed PDUFA agreement does not meet Congressional standards; and supported including a system in the reauthorization to measure approval times in relation to increases in funding.