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Advocacy at a Glance

September 14, 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.

  • Challenges of FDA in a Globalized World. Monday, September 17th, 2:00 p.m.-3:00 p.m. Location: 2456 Rayburn House Office Building. The Alliance for a Stronger FDA along with Chairman Jack Kingston (R-GA) and Ranking Member Sam Farr (D-CA) of the Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies are sponsoring a Capitol Hill Briefing on Monday, “Challenges of FDA in a Globalized World.” The target audience is Capitol Hill staff. The event will be moderated by Margaret Anderson, Alliance for a Stronger FDA, Executive Director of FasterCures/The Center for Accelerating Medical Solutions. Speakers at the event will be Marcie McClintic Coates, Vice President and Chief of Staff in the Office of the CEO at Mylan; Ron Guido, Vice President, Global Brand Protection and Supply Chain Integrity, Johnson & Johnson; and Caroline Smith DeWaal, Director of the Food Safety Program, Center for Science in the Public Interest. While this is mainly intended for Capitol Hill staff, we likely will have a few seats open for Alliance members. Please RSVP by e-mail to Jason Denby, if you are interested in attending.
  • Sequester Transparency Report. Before leaving for August recess, Congress directed the Administration to provide a detailed view of how sequestration would affect specific government programs. The report is expected sometime today (Friday). We will provide more details as we have them. Some of the issues are discussed in this week’s “Analysis and Commentary.”
  • FDA and the Maintenance of Effort Trigger. Both the PDUFA and MDUFA contain provisions that require the Congress to maintain spending of BA (taxpayer) monies in order for the user fee programs to operate. The rationale is that user fees were meant to add to, not supplant, the monies available to support FDA activities. Notwithstanding a news story earlier this week that was widely reprinted, it is our best understanding that sequester at currently intended levels (about 8%) will not trigger the maintenance of effort requirements

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