Advocacy at a Glance

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.

• Omnibus vs. CR: Rumblings Heard on the Hill. Everyone seems to agree: Congress is only likely to be in session for about 2 weeks in September before adjourning for the October/pre-Election recess. Senator Mikulski, chair of the Senate Appropriations Committee, is acknowledging that the timeframe is short, but that she still would like to try to pass an omnibus bill. That is, she would like one bill that would contain full appropriations bills for some agencies and a continuing resolution (CR) for those agencies on which immediate agreement is not possible. Representative Rogers, chair of the House Appropriations Committee, has the same goal, but has said he thinks it is unrealistic. The consensus is that Congress will pass a Continuing Resolution at the FY 14 (current year) levels and have it run until mid-November or early December.

• FDA Research: An Example of Regulatory Science in Action. From time to time, we are asked why the word “research” is in the name of CDER and CBER. The answer is that both Centers (along with all the other centers at FDA) are engaged in research that strengthens the agency’s ability to efficiently and accurately review products and oversee the nation’s supply of food, drug, cosmetics, veterinary foods and medicines, etc. While this has come to be called "regulatory sciences", it is actually a longstanding part of the agency’s mission. By way of illustration, FDA Voice has published an update on FDA’s research in support of the development of stem cell-based therapies and regenerative medicine.

• Anomalies, User Fees and the Continuing Resolution. With the likelihood of a continuing resolution (CR) to start FY 15 on October 1, there are a number of looming issues we have described previously previously, such as duration, funding level, and an exceptions process called “anomalies.”  The latter refers to any situation where “continuing” 2014 programs into FY 15 would create problems or inconsistencies and require special language to patch. Generally speaking, we do not think FDA will need anomalies, but this judgment is often highly technical. We will probably know what FDA and OMB think by early September when they provide recommendations to Congress. With specific reference to user fees -- which increase by an inflation factor each year -- the Hill has assured us that this will be taken care of so that FDA can collect and spend the higher amounts in FY 15. What is unclear is whether: language in the FY 14 appropriations bill allows higher levels and is “continued” under a FY 15 CR or there is still need for a provision in the CR. If (anomaly) language is required, then we are told it is straightforward and has been used in prior years.

• FDA Funding and the 2014 Election. We know of no state or district in which FDA is an election issue of any consequence. Nonetheless, the election will shape the next Congress and may affect FDA’s funding in FY 16 and FY 17 (and possibly FY 15 if Congress doesn’t act this year).  Some of the possible changes are discussed in this week’s Analysis and Commentary.