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Advocacy at a Glance

May 15, 2015

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.

  • FDA Funding Reported to Be Included in Ongoing “Cures” Negotiations.   Politico Pulse is reporting that Representative Diana DeGette (D, CO) and Energy and Commerce Chairman Fred Upton (R, MI) are currently negotiating additional funding for FDA as part of the 21st Century Cures legislation.  The Congresswoman indicated that while she and the Chairman have agreed that the FDA will indeed get more dollars, “we’re waiting to see what the CBO has to say,” before agreeing on a final number for the agency.
  • As Health Subcommittee Marks-up “Cures” FDA’s “To Do List” Grows. More than half of the 300 pages in the House Energy and Commerce Committee’s “21st Century Cures” legislation is devoted to FDA. It would impose dozens of new requirements upon the agency’s already long list of responsibilities. While the Alliance takes no position on the substance, we are very concerned that FDA have enough resources to carry out any new directives. For more on this situation, read today’s Analysis and Commentary.
  • More Food Industry Support for Increased Food Safety Funding. Two weeks ago, we referenced broad food industry support for the President’s $109.5 million proposed increase in FSMA funding. This was reinforced by a May 7 op-ed in The Hill newspaper, written by Nestle’s Food Safety Director, Tim Jackson, PhD
  • FY 16 Appropriations: Slow Progress. The Congressional budget resolution stoked Congressional disagreements by keeping non-defense spending at the cap levels specified in the Budget Control Act (about $20 billion less than the President’s request), while adding $38 billion for defense programs using an off-budget fund for war-related expenses. This serves as a politically-charged backdrop as the House starts to take up individual appropriations bills and the Senate prepares to get started with budget allocations to the appropriations subcommittees.
    • According to Politico, House Agriculture Appropriations subcommittee chair Robert Aderholt is projecting a mid-June date for mark-up of the Ag/FDA funding bill.
  • PDUFA Reauthorization Cycle to Start in July. The FDA announced the first public hearing on reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2018 through 2022. The public meeting will be held on July 15, 2015, from 9 a.m. to 2 p.m.
  • New Fiscal Cliff: Expiration of Highway Trust Fund. Since the beginning of this year, the Alliance has tracked and regularly communicated information about so-called fiscal cliffs: situations where Congress may reach an impasse and a budgetary deadline looms. The latest potential “cliff” is the Highway Trust Fund, which expires at the end of May and runs out of money in July.
  • FDA Names Finalists in Food Safety Challenge. Last September, Analysis and Commentary described a $500,000 X-Prize type competition being sponsored by FDA to develop new regulatory science tools for assuring food safety. We saw it as illustrating three themes: FDA’s work is infinitely challenging; FDA is not afraid to try new approaches to fulfilling its mission; and regulatory science must be continually improved. FDA has just announced the five finalists who will be competing for the prize, as described here.

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