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The Friday Update — October 30, 2009

November 27, 2009

ADVOCACY

  • Principal Deputy Commissioner Joshua Sharfstein Addressed the Alliance Yesterday at the Annual Member Meeting. (For more on Dr. Sharfstein’s address, please see below.)
  • CVM Meeting. The Alliance also met with the Director of  FDA’s Center for Veterinarian Medicine Bernadette Dunham this past Wednesday.
  • FY 2011 Request. The Alliance’s request for FY 2011 FDA funding is $2.857 billion.  Please see the attachment and the Grossman Analysis for a detailed breakdown of the request.
  • Metrics Sub-Group Conference Calls: November 12 and 13. Please note that the Alliance metrics sub-groups will be convening working group teleconferences on the following days and times:
    • Thursday, November 12 at 10:30 am-12:30 pm Eastern — Drugs/Biologics Subgroup
    • Thursday, November 12 at 1:30 pm-3:30 pm Eastern — Food Subgroup
    • Friday, November 13 at 10:30 am-12:30 pm Eastern — Devices Subgroup

ANNUAL BUSINESS MEETING

  • E-mail Ballots for Directorships. Please be aware that you will be receiving an e-mail ballot in the next few days requesting your vote on a proposed slate of nominees for 2010 Board Membership.  The ballot will contain further details and relevant information.

THE GROSSMAN ANALYSIS

I am probably the only person in DC who is not writing about health reform this week. Instead, I will talk about Dr. Sharfstein’s remarks to the Alliance’s membership meeting yesterday. I will also talk briefly about the Alliance’s FY 11 request for FDA appropriations.

For the Alliance’s Annual Meeting (our 4th quarter member meeting), we were honored to have Dr. Josh Sharfstein, Principal Deputy Commissioner at FDA, provide remarks. He started by thanking the Alliance and its members for their support of FDA. He underscored the important role we play by educating policymakers and the public about the resource needs of the agency. He then continued by talking about his and Dr. Hamburg’s efforts to restore credibility to the agency. He sees this as a work in progress.

As part of restoring credibility, he pointed to: transparency of action, enforcement of laws, integrity in scientific decisionmaking, and meeting public health goals. As an illustration of all four, he pointed to an association  meeting that he had been at this week. There was question after question about a recent FDA regulatory enforcement action. While Dr. Sharfstein believes the agency acted appropriately, it had failed to take time to communicate its rationale as well as its decision. Later, people may still disagree, but credibility comes from listening, interacting and explaining, rather than being seen as always saying “yes” or “no” without helping stakeholders understand.

He also touched on some of the priorities that are emerging for the new FDA leadership team. Dr. Hamburg and he will continue to speak about regulatory science and making its advancement an agency priority. They are determined to turn food safety from a crisis mode to a preventive system. Globalization and supply chain issues are never far from his and Dr. Hamburg’s minds. Innovation is another major theme. Billions are being spent on research and too little of it is translated into products and procures that help patients and consumers. FDA needs to help companies in this process: not by lowering standards, but by communicating more clearly what the standards are and what is needed to meet them.

After Dr. Sharfstein finished and left the building, we continued with the member’s meeting. A highlight was the release of the Alliance’s FY 11 request (see attached file). FDA’s FY 10 appropriation is $302 million more than FY 09. Our goal is for the agency to receive  a $500 million increase in FY 11. This is about a 20% increase. Please look at the chart and see how much progress we have made in a few years; over the next few weeks I will devote columns to why the agency still needs more.

We hear again and again — from the Hill, media and the executive branch — that our effectiveness comes in part from the diversity of interests that belong to the Alliance. Let’s keep that unity going into the new year, strengthening our efforts to get FDA a further substantial increase in FY 11.

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

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