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Advocacy at a Glance

May 2, 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.

  • Join Us Next Week: Freshman and Sophomore Hill Days, May 6-7. The Alliance has arranged a series of meetings with the staff of Freshman and Sophomore members of Congress on the following two days: May 6th and May 7th. The purpose of the meetings is to provide staffers with consumer, patient, and regulated industry perspectives on the critical importance of FDA and to provide basic background on how the agency works. Alliance Members and other interested parties are encouraged to participate in the meetings.  Please e-mail Tony Curry if you are interested in participating in the Hill Meetings.
  • FDA Outlines Food Safety Plan, Should It Get Funding?  FDA’s Center for Food Safety and Applied Nutrition (CFSAN) provided a constituent update on its plans to implement FSMA.  This is FDA’s most comprehensive public explanation of how it would spend any additional funding in its effort to modernize the food safety program.  Also, as part of its effort to develop stakeholder consensus on the food program’s funding needs, earlier in the week FDA Deputy Commissioner Mike Taylor responded to concerns about how it has spent past additional funding.
  • House Energy and Commerce Committee to Explore 21st Century Cures and Implications for FDA and NIH. As was discussed this week at the Alliance’s quarterly member meeting, House E&C Chairman Fred Upton (R, MI) and Representative Diana DeGette (D, CO) have announced a year-long review of how Congress can help accelerate the discovery, development, and delivery of promising new treatments to patients. The first hearing is on Wednesday, May 6, and will feature CDER Director Janet Woodcock, CDHR Director Jeff Shuren, and NIH Director Francis Collins.
  • House Moves Forward on Funding Bills.  As previously reported, the House has already started to move on the Military Construction/VA and Legislative Branch appropriations bills. On April 29, House Republicans unveiled their next bill: Commerce, Justice and Science (CJS) appropriations. It is widely expected that Agriculture (including FDA) will be soon … either next week or the one after. Two things are notable about the draft CJS bill: the bill contains funding at the $51.2 billion level despite the lack of 302(b) allocations to other subcommittees; and that amount is $1 billion higher than the President’s request, which implies that some of the later appropriations bills will have to make up the difference.
  • FDA Visits to White House/OMB: An Analysis. Regulatory Focus, published by the Regulatory Affairs Professional Society (RAPS), has examined how often FDA officials have visited with White House and OMB officials over the last 4 years. According to their analysis, FDA Commissioner Hamburg made 61 visits during this period, senior policy and legislative staff made 81 visits, and center directors only nine visits. Dr. Hamburg most frequently met with the Office of Information and Regulatory Affairs (OIRA) at OMB, the unit responsible for clearance of regulations.

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