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A Successful Hearing on the House Side

March 2, 2012

Six years as a staffer on Capitol Hill taught me that a Congressional hearing is a form of political theatre. It should be well-scripted, with just enough room for improvisation that it is neither boring nor predictable. At its best, the hearing ends with the Chairman and other Members feeling well-satisfied that they have made their points … and reminded the Executive Branch that they still make the laws and approve the funding.

In turn, government witnesses have the rare opportunity to tell their story in front of Congress and the media — without interruption and usually for at least 5 to 10 minutes. They can forthrightly speak of their agency’s accomplishment and needs and their vision for its future. They can answer questions directly, providing their interpretation of events and decisions. So, apart from some anxiety about providing good answers to a few unexpected questions, well-run Congressional hearings can also work out well for those testifying.

By these standards, Chairman Kingston, Ranking Member Farr, Commissioner Hamburg, and others Members had a successful hearing on Wednesday. All the scripts worked and the improvisation did not get out of hand. Everyone appears to have achieved their objectives.

Here are some of the things we learned:

  • Chairman Kingston is generally supportive of the FDA’s budget request. He is still interested in further savings and greater efficiencies by: keeping the agency from engaging in activities that he views as peripheral to its mission; and consolidating duplicative programs.
  • Commissioner Hamburg articulated the agency’s primary messages for the FY 13 round of budget discussions. Specifically:
    • Concrete Investments = Concrete Results.  “With the funding you have provided, we have delivered significant and quantifiable benefits to the American people, and we are very proud of these achievements.”
    • Maximizing the Impact of Agency Funds. “It is more important than ever to focus on our core functions and to actively look for opportunities to streamline activities and leverage human and financial resources.”
    • Preparing FDA for the Challenges Ahead. “FDA’s mission is challenging, even in the best of times, with scientific advances occurring at breakneck speed, and the pace of globalization accelerating. Our responsibilities are vast and growing, a trend that will only continue.”
    • Next Steps: Investing in FY 2013. “In this budget, you will see our commitment to smart regulation and efficacy in medical product review. … Our commitment to fostering innovation is woven into the fabric of this budget … you will see our commitment to significant safety initiatives … you will see our commitment to building a strong and reliable food safety system, focused on prevention and leveraging the valuable work of our partners in state and local governments.”
  • The Subcommittee members having varying views of the proposed user fees that make up 98% of the proposed increase in the agency’s FY 13 budget. Without citing specifics, Chairman Kingston’s opening remarks note that some of the user fee requests may not make it through the authorizing committee and that one has already drawn significant opposition. Representative De Lauro advocated more appropriated dollars in place of making FDA overly reliant on user fees. Both Representative Farr (a Democrat, the Ranking Member) and Representative Latham (a Republican) asked about the Food Safety Modernization Act and whether the proposed user fee was an appropriate and reliable way to fund its implementation.
  • Among a number of issues raised by Members, the review process for medical devices drew particular attention. Chairman Kingston expressed concern that the agency had become too risk-adverse in its decisions on devices and that there was insufficient agency transparency in their interactions with device companies.

Commissioner Hamburg will also testify to the Senate Subcommittee on Agriculture/FDA Appropriations. However, no date for the hearing has been announced.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.

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