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Four More Qs and Four More As

February 22, 2019

Q: What happened at the Alliance’s February 13 meetings with the offices of Ag/FDA subcommittee members?

A: We were pleased with the positive reception we received in both House and Senate offices and in all 20 meetings. There were a number of probing questions, but none were ideological or partisan. Notably, FDA was viewed favorably by both Republicans and Democrats. Commissioner Gottlieb received high marks from all. What became apparent is a wide gulf in FDA knowledge between staff of Members continuing on the subcommittee and staff of Members newly appointed to the subcommittee. We see the Alliance as a continuing resource for both, but at this point the needs of each group are quite different.

If you weren’t part of the February 13 meetings, we strongly encourage you to sign up for Alliance Lobby Day on March 19. The more participants, the more meetings we can set up for that day. Interacting with staff serves the FDA’s cause, but it is also enjoyable to learn about other parts of FDA from your team members.

Q: Some media have said that FDA received $3.07 billion in BA (taxpayer) funding and $2.52 billion in user fees. Is the agency really split 55% BA and 45% user fees?

A: Not in the Alliance’s view. We always exclude the tobacco center ($712 million of user fees, no BA) from our analysis. That gives a clearer picture of what people really want to know: how much of food, drugs, and device programs are paid by taxpayers (BA) and how much by industry (user fees). Excluding tobacco, FY 19 breaks down this way: $4.9 billion total, with $3.1 billion BA and $1.8 billion from user fees. That’s roughly 63% BA and 37% user fees. Of course, FDA needs both types of funding. Our reasoning is more fully explained at: The FDA budget FY 18: Where does the money come from? Interestingly, FDA recently described the budget in the same terms in an FDA at a Glance fact sheet (see last bullet before the appropriations chart).

Q: How did “21st Century Cures” funding fare under the final FY 19 funding bill?

A: The conference agreement (which has become law) contains a $269 million increase for FDA in FY 19. This is about a 9% increase and brings total appropriated funding to $3.068 billion. Neither of these totals includes monies for the FDA Innovation Fund, which was created by the 21st Century Cures Act and intended to be funded separately. Congress sent $70 million to the fund, the entire amount authorized for FY 19.

Q: I was told that certain report language was in the Explanatory Statement of the Conferees on the Consolidated Appropriations Act of 2019. Why can’t I find it?

A: As is customary, the Consolidated Appropriations Act revives language from the House and Senate committee reports that were published at the time the appropriations bills first passed out of committee. That is, they are given effect unless the Explanatory Statement of the conferees overrides a specific provision from a committee report. The relevant House report is here and the relevant Senate report is here. In all likelihood, if you can’t find something in the Joint Explanatory Statement of the Conferees here, it will be in one of those reports.

Editorial note: The Analysis and Commentary Section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.

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