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Advocacy at a Glance

May 11, 2014

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.

  • House Committee Votes on Subcommittee 302(b) Allocations. The House Appropriations Committee adopted 302(b) allocations this week — effectively telling each of its subcommittees how much they have to spend. The Agriculture/FDA subcommittee will have $20.880 billion to spend, approximately the same amount that the Congress appropriated for the Ag/DA programs in FY 14. Agriculture/FDA was fortunate — some subcommittees received FY 15 allocations that were less than FY 14 levels — but it still means that FDA will be in a hard competition because the funding levels of some agriculture programs increase automatically, leaving less for other programs. Senate 302(b) allocations have not yet been released.
  • It Needed To Be Said. At the House Energy and Commerce Committee’s roundtable on “21st Century Cures,” Faster Cures CEO and former Alliance President Margaret Anderson told committee members: “The appropriated dollars that go to the FDA are extremely valuable, and they are not enough.”
  • House/Senate Ag/FDA Appropriations Mark-Ups Are Coming. At this point, no agriculture/FDA appropriations mark-up dates have been released by either the House or the Senate. Nonetheless, it remains our belief that each House will consider Ag/FDA appropriations (at subcommittee or full committee level) yet this month.
  • Medical Product Review Times Back in the News. Going back more than 30 years, a part of FDA’s history has been shaped by Congressional concern about whether there is a “drug lag” in which medical products are approved sooner in Europe than in the US. This is also becoming part of a larger issue about maintaining American leadership in medical innovation that is being raised in the House Energy and Commerce Committee’s 21st Century Cures initiative. In a blog column this week, Commissioner Hamburg provided her perspective, based on some recent research comparing review times among the US, Europe, and Japan and based on some recent FDA initiatives in the medical device area.
  • Regulatory Science Alive and Expanding. FDA has added two new Centers of Excellence in Regulatory Science and Innovation (CERSI). The UCSF-Stanford center will bring a West Coast presence to the CERSI network and enable FDA to access UCSF’s expertise in quantitative sciences and pharmacology. The Johns Hopkins center will focus on three core FDA strategic priorities: clinical evaluation, social and behavioral science, and food safety. This brings to four the academic partnerships supporting FDA’s efforts to bring new tools to the process of modernizing regulation and stimulating innovation. The others are at Georgetown University and the University of Maryland.
  • Educating Congress About FDA. This week, 25 Alliance members participated in 30 meetings with the offices of Freshmen and Sophomore Members of the House of Representatives. This week’s Analysis and Commentary discusses the meetings and why they are an important part of the Alliance’s mission.

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