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.

• CBO Score on Senate FDARA Bill Leads to Confusion About Unfunded Mandates. Late last week, the Congressional Budget Office released its budget estimates for the version of the FDA Reauthorization Act (FDARA) that was reported favorably by the Senate HELP Committee. To the surprise of many of us, CBO identified a 5-year cost of $1.2 billion in non-user fee funding for programs and requirements under FDARA, i.e., separate and distinct from user fee monies being reauthorized under the bill. This week’s Analysis and Commentary explores whether the CBO report is a fair representation of the activities and costs that FDARA would impose on FDA. Hint: It’s not.

• Commissioner Gottlieb Testifies Before Senate Ag/FDA Appropriations Subcommittee. The Commissioner’s testimony and answers to Q&A covered a broad range of topics. Of particular interest to the Alliance: he re-affirmed that the hiring freeze has been lifted and he expect vacancies to be filled going forward. Also, Chairman Hoeven pointed out that the extra user fees in  the President’s proposal were not going to be enacted and asked the Commissioner’s views on this. Commissioner Gottlieb said that FDA can always do more with more, but he is looking for potential efficiencies. He also said that FDA appreciates the food safety resources that have been provided by the committee, and he noted that this attention is quite different than when he left the agency 10 years ago.

• August Recess a Possible Deadline for Budget and Appropriations Decisions?  Congress is already late putting together House and Senate budget resolutions for FY 18. There is some urgency to getting those resolved before the August recess. Appropriations bills for FY 18 are slowly beginning to move in the House, held back by the lack of budget resolutions and the late arrival of the President’s Request. Those will need to be resolved by September 30 at the latest. Finally -- and hardly least -- is the need to raise the federal debt ceiling. The original target was this Fall, but there are some indications that Treasury will need Congress to act by August. How these get sorted out -- separately or in a large package in July or September -- is evolving and we will be tracking it. While this is “big picture,” the impact of these macro-budgetary decisions will be felt by FDA. We explained this in an earlier post, here.

• More House Appropriations Subcommittees Schedule Mark-ups. The House has now scheduled two additional appropriations subcommittee mark-ups. Legislative Branch is today (June 23) and Defense on Monday (June 26). Because there is no FY 18 House Budget Resolution to guide total spending, it is not clear how the subcommittees know how much they can spend. With these two subcommittees (plus Military Construction/VA last week) marking up, there is also the concern that any increases in their allocations (above FY 17) may leave too little money left for later subcommittee mark-ups.