Advocacy at a Glance

Oct 3

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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.

Quiet Start to Fiscal Year 2015. In sharp contrast with last year’s shutdown, FY 15 started uneventfully on October 1 with all of the federal government funded under a Continuing Resolution that runs through December 11. For the next 10 weeks, FDA will not have any additional funding to fulfill its increased responsibilities. Rather, the agency will be able to spend at its FY 14 rate minus a small adjustment taken from all federal agencies to pay for some emergency activities (e.g., Ebola). Our understanding is that appropriations staff will be talking over the long election recess, trying to reach preliminary agreements on appropriations bills that might be included in a omnibus. The committees will start to examine them informally upon their return in November — looking to see if common ground can be achieved.

Poll: FDA More Favorably Rated than Many Other Federal Agencies. A recent poll showed that 58% of respondents had a favorable view of the FDA, with men being more favorable than women. This was better than other federal regulatory agencies, but still reflects substantial resistance to regulation and misunderstanding about FDA’s role. This is discussed further in this week’s Analysis and Commentary.

Public Health Groups Advocate for Increased Food Safety Funding. A group of 16 medical and public health organizations requested that the House and Senate Appropriations committees add at least $50 million to the FY 15 budget for the Food and Drug Administration’s (FDA) to implement the Food Safety and Modernization Act (FSMA). The letter states, “Additional funding beyond the amount currently allocated by your Committees would permit FDA to substantially advance key priorities in its domestic FSMA implementation timeline, including necessary investments in the National Integrated Food Safety System, education and technical assistance for industry stakeholders, and modernization and training for its inspection service.”

FDA Releases Strategic Priorities for 2014-2018. FDA Commissioner Hamburg announced FDA Commissioner Hamburg announced the agency's updated strategic priorities for the next 4 years. Five priorities form the basis of the plan: regulatory science, globalization, safety and quality, smart regulation, and stewardship (of resources). The agency asserts that, while each priority is important in its own right, the agency’s effectiveness is dependent on implementing them simultaneously, recognizing the inter-relatedness among them.

FDA's Mini-Sentinel Program: From Pilot to Ongoing Initiative. Effective October 1, the FDA's Mini-Sentinel project has advanced from pilot to an ongoing initiative that will be integrated into FDA’s overall drug safety monitoring. The project has the ability to evaluate the safety of drugs through the electronic health records of 175 million Americans. Even as the Mini-Sentinel becomes a more central tool for the agency, there are challenges in determining which trends are real and which just a blip in the data. This is discussed in an article in Nature.

Good ... But Not Good Enough!