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Advocacy at a Glance

July 27, 2012

Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

  • Update on FY 13 Continuing Resolution: As described in last week’s Analysis and Commentary, the only spending decision that Congress has to make before the election is the funding formula and duration of the Continuing Resolution that will fund federal programs when the new fiscal year begins on October 1, 2012. There is an effort underway, likely to be unveiled early next week, to have Congress pass a 6-month Continuing Resolution (October 1, 2012 to March 31, 2013) before it leaves for August recess. The advantage of getting this done early would be to neutralize any efforts to fight over the CR in late September, which might risk shutting down the federal government (for lack of funding) about  5 weeks before the election.  There has been no official announcement, so things could change, but we wanted Alliance membership to be aware of the potential development.
  • Update on Sequestration:  One of the unanswered questions about sequestration was the organizational level at which the cuts would be made. For example, if sequestration were to apply at the Cabinet level, the Secretary of HHS would see the 7% to 10% cut taken against HHS programs and be able to prioritize funds among them.  She might choose to preserve FDA’s funding level, while cutting another program by a greater amount than the average cut. We have been told that it will not work that way — that the across-the board cuts are intended to be applied at the division/program level (i.e., at FDA, this would be the center level).  For CDER, for example, Dr. Woodcock and the Commissioner would have to decide which programs receive increased funding or held level,  which might be eliminated, and which might take cuts of greater than 7% to 10% to offset increases for other programs. We presume, but do not know for sure, that Dr. Woodcock would still need to distinguish center and field programs and could not substitute funds from one to offset cuts in the other. Further, we also presume that statutory mandates are still in force (e.g., $20 million in CDER/CBER appropriated funding is necessary to kickstart the biosimilar user fee program).
  • Alliance for a Stronger FDA Quarterly Membership Meeting, Tuesday, July 31 at 2:00 p.m.   The next Alliance quarterly membership meeting will occur on Tuesday, July 31 at 2:00 p.m. ET.  In lieu of a single speaker, we will have a panel of Congressional “insiders” from Akin Gump talk about the upcoming election and its likely impact on FDA and federal discretionary funding.  This panel will include former Congressman Vic Fazio (D-CA), once a member of the Agriculture Appropriations Committee, and Juliane Sullivan, former appropriations staffer to Majority Leader Tom DeLay (R-TX).
  • Office of Management and Budget Meeting.  This week  the Alliance  met with officials from OMB to discuss FDA’s appropriated funding for FY 2013 and FY 2014.
  • FDA Chief Information Officer Meeting, August 22 at 2:00 p.m.  Eric Perakslis, the CIO of FDA has agreed to meet with the Alliance to discuss how the agency’s resources impact its technological and informational capacities.   Please let us know if you are interested in participating in the meeting.  The meeting will take place on August 22 at 2:00 p.m.

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