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.

• House Appropriators Lack Subcommittee Allocations. As the House left town for a recess that extends until April 12, House Appropriations chair Harold Rogers (R, KY) indicated that subcommittee chairs had not yet been given estimated allocations of how much they will have to spend in discretionary dollars. Without that, staff will have only limited ability to work on funding bills while the Members are away. The full committee is scheduled to meet on April 13 and there is hope that the allocations will be released and voted upon then. Other sources have said that the subcommittees are working off last year’s allocations as rough guides to the amount they have to spend this year and that staff will be active over the recess.

• FDA to Allocate $19M in FY 16 to State Enforcement of Food Safety Laws. One of the foundations of FDA’s implementation of the Food Safety Modernization Act is cooperative agreements with state food safety agencies. FDA has announced that they have allocated $19 million for those purposes in FY 16. There is sentiment that this number needs to be much higher in FY 17. The National Association of State Departments of Agriculture has stated publicly that $100 million will be needed for states if FSMA goals are to be met.

• Cost of Biosimilars Program Outstrips Monies Available from User Fees. One of the areas of pressing need is for additional appropriations for FDA’s biosimilars program. According to Dr. Woodcock, more than 50 applications are in some state of development, overwhelming available FDA resources. While the program comes with a user fee program, it was never supposed to produce more than half the program costs.

• Introduction of FDA-Related Bills Continues. We haven’t stopped to count, but it seems like there are a lot more individual FDA-related bills being introduced over the last year than there have been in previous years. Volume is up further if you count the House Cures legislation, an omnibus bill, as if each title was a separate bill. Does FDA benefit from so much attention from legislators? This topic is discussed in this week’s Analysis and Commentary.

• Alliance’s FDA 101 Hill Day is May 4th. We spend the first few months of the year meeting with appropriators and authorizers -- congressional offices who have FDA in their jurisdiction. Beyond that, there is great value in educating a broader group of congressional offices about FDA’s important work. Please put a note on your calendar and join us on May 4!