July 2011

Commissioner Stresses the Importance of User Fees Before Senate Committee

On July 28th FDA Commissioner Margaret Hamburg appeared before the Senate Committee on Health, Education, Labor and Pensions to testify about the agency’s user fee programs and their impact on public health.   This was the second hearing on the importance of the user fee programs’ reauthorization this month.

Hamburg’s statement stressed the central role user fees, play in ensuring the success of FDA’s efforts to, “promote science and innovation” and bolstering  FDA’s capacity to address “public health issues of the 21st century and to address the continuing challenges of a global marketplace.” The commissioner pointed out that before the enactment of PDUFA in 1992, the FDA review process was, “understaffed, unpredictable, and slow.”  She went on to say that the understaffed FDA was unable to perform timely reviews, develop procedures, and set standards that would have made the process more, “rigorous, consistent and predictable.”

Commissioner Hamburg cited one particular study by the Tufts Center for the Study of Drug Development which notes that since PDUFA’s enactment the approval phase of new drug development has been cut by 60 percent, dropping it from an average of 2.0 years, to 1.1 years.  The same study also noted that so far this year, the FDA has approved twenty-one new ground breaking medicines which is the same number of “novel drugs approved in all of 2010.”

Hamburg closed by reminding the committee that the current user fess programs, PDUFA IV and MDUFA II, expire on Sept. 30, 2012, and that the FDA  is, “ready to work with [Congress] to ensure the timely reauthorization.” 

To watch the video of the hearing, click here.

To view Commissioner Hamburg’s prepared statement, click here.

FDA Center for Drug Evaluation and Research develops strategic science and research agenda

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) released a report on July 25th entitled, “Identifying CDER’s Science and Research Needs Report.”  The document identifies current regulatory science needs that will guide the agency’s strategic planning for both internal research initiatives, and the development of regulatory science efforts.

The aim of the report was to stimulate research and foster joint efforts with outside partners in the areas of greatest need.  CDER director, Dr. Janet Woodcock, highlighted the following top science and research needs for partnership:

  • Improving access to post-market data sources and explore feasibility of their use in different types of analyses
  • Improving risk assessment and management strategies to reinforce the safe use of drugs
  • Evaluating the effectiveness and impact of different types of regulatory communications to the public and other stakeholders
  • Evaluating the link among product quality attributes, manufacturing processes and product performance
  • Developing and improve predictive models of safety and efficacy in humans
  • Improving clinical trial design, analysis and conduct
  • Enhancing individualization of patient treatment

This docket is open for review and public comment, and will remain so for 60 days after its publication in the Federal Register.

To view the full report, click here.

ACT-AD Chair speaks to BioCentury This Week about PDUFA V

On June 26th, Daniel Perry ACT-AD’s Chair was interviewed by BioCentury This Week to share his impressions on the fifth reauthorization of the Food and Drug Administration’s (FDA) Prescription Drug User Fee program (PDUFA). During the interview, Perry commends Congress for giving ACT-AD members and other active patient group, the ability to lend an early voice in shaping how user fees might be employed to help speed the delivery of better treatments and cures to patients in need of relief from a multitude of diseases including Alzheimer’s.

Perry’s statements recognized that the user fee program was created to ensure the timely review of products submitted to the FDA and cautioned that FDA should continue to utilizethem to support initiatives that achieve this same end. Details that are avaiable on the current PDUFA draft agreement indicate that it would enable FDA to execute its charge more effectively. This could have a direct and lasting benefit for patients.

To view Perry’s interview click here, and here.