Sorting Out the Details of the President's FY 20 Request

Q: What else did Congressional offices tell Alliance members on Hill Day?

A: One of the Alliance’s key messages is that:

Assuring safe food and safe and effective medical products are core functions of government, not unlike assuring safe air travel and providing for the common defense.

Usually, staff do not engage us on this point -- seeing it as either self-evident or exaggerated. This year was different; this message visibly resonated with staffers. They wanted to talk more about FDA’s multiple responsibilities and how much the shutdown demonstrated how vulnerable the nation is without a well-functioning FDA.

Q: Why is there so much inconsistency in the numbers attributed to the President’s budget request for FDA?

A: FDA’s budget is complex. One reason is that multiple funding sources flow into the agency. Depending on what you count -- BA, BA + user fees, with or without proposed new fees, with or without tobacco user fees -- very different numbers can emerge. For a more complete explanation, see an earlier Analysis and Commentary column, here. Another reason is that FDA has so many more functions than other agencies. To take an extreme contrast, the Social Security Administration is enormous, but only has three functions that it repeats millions of times: verify eligibility (for SS or disability), cut and deliver checks to homes or bank accounts, and update addresses. A third reason for confusion and inconsistency -- at least this year -- is that the base year for comparison is the FY 19 Continuing Resolution levels, rather than the FY 19 final.

Q: Does the President’s budget request include the funds set-aside to pay for 21st Century Cures programming?

A: Yes. This also provides another example of inconsistent numbers. Under the FY 19 CR, Cures funding was carried over at the FY 18 level of $60 million. The FY 19 final provides the full $75 million allowed by law. For legitimate but confusing reasons, this leads the President’s FY 20 request to claim a $15 million increase. Apart from that, the President’s recommendation for Cures funding is meaningless because the Cures monies -- which go into the FDA Innovations Fund -- come from mandatory funding (not discretionary). This was accomplished by the Senate HELP and House E&C committees agreeing to reduce mandatory spending elsewhere within their jurisdiction. In order to satisfy concerns expressed by appropriations committee members, the money can’t be transferred without being included in an appropriations bill. However, being that the monies come from mandatory programs, they do not count against the non-defense discretionary (NDD) budget cap. Each year, the appropriations committees have transferred these monies to the FDA Innovations Fund in a separate section of the appropriations bill.

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