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Advocacy at a Glance

May 10, 2019

No Budget Agreement: House Moves Forward, Senate Waits. Under “normal order” in the annual appropriations process, the House and Senate Budget Committees develop an early agreement on the total spending levels for the entirety of defense and non-defense discretionary spending. That topline spending number is known as the “302(a)” spending ceiling, and under normal order it is typically completed by the end of April. Once that agreement is reached, the Appropriations committees divvy up the 302(a) money, assigning a portion to each subcommittee. The subcommittee allocations are known as the “302(b) allocations”  and under normal order are typically determined in the May time frame.  Over the past several years, we have gotten used to the appropriations process not following the “normal order,” and this year is no different than the past several years.

Under the Budget Control Act of 2011, the ceiling number for FY 20 would require a $70 billion cut to defense programs relative to FY 19 and $50 billion less to non-defense programs relative to FY 19.  It is widely understood that Congress will need to lift the caps, or face the prospect of massive spending cuts. The key issue being: to what levels will the caps be lifted? The resolution of that may take weeks or maybe even more time and could delay the entire appropriations process. For a deeper look at how that might play out, see this week’s Analysis and Commentary.

Regardless of the lack of resolution on the 302(a) and a 302(b) numbers, the House has chosen to move the appropriations process forward. They have created a 302(a) level that they would like to see adopted by Congress and then made 302(b) subcommittee allocations. Numbers are likely to be different in the final budget agreement and in Senate subcommittee allocations, but at least some of the hard work of program funding will be started. It is possible that the Senate may wait for a House/Senate agreement on budget ceilings before deciding on their own subcommittee allocations. This is subject to change, especially if it appears that a budget agreement is unlikely in the near term.

The House Ag/FDA Appropriations Subcommittee Allocation Would Increase Spending Above the FY 19 Levels. As noted above, the numbers being used in the House appropriations process are meaningful, but have a high risk of revision as the House and Senate continue to negotiate budget numbers. Nonetheless, the House Ag/FDA allocation is $24.3 billion, a $700 million year-over-year increase. This is a 3% increase, comparable to the increase for defense, but less than a number of other subcommittees that were raised by 4% to 8%.

L-HHS and Defense Moving in the House, Ag/FDA Later in May or Early June. A key learning in the FY 19 process was that pairing the L-HHS and DOD funding bills made for smoother passage in Congress and was virtually veto-proof. Those two bills are now part of the first wave of funding bills in the House, along with the non-controversial Military Construction/VA and Legislative Branch bills. Ag/FDA may come up the week of May 13 (next week), but more likely the week of May 20 or in early June when the House returns from Memorial Day recess week.

Senate Minority Leader Schumer Advocates for Food Safety Funding. In a statement released by Sen. Chuck Schumer last week, he expressed support for $32 million for food safety funding that is included in the President’s FY 20 budget request. Half of this amount would be used to improve signal detection of foodborne illness and strengthen the FDA’s response to human and animal food contamination. The other half would be for improving food safety inspections using new technologies. He does not address other opportunities at CFSAN and CVM.  Taking a broader perspective, the Alliance requested that Congress appropriate $102 million for food safety programs. The text of the Alliance “ask” is here.

Federal Budgeting: A Brief Refresher Course

May 3, 2019

For all readers, both new and old, we are providing a refresher this week on the federal budget, with an eye on how it applies to FDA resources in the current FY 20 funding cycle. … READ MORE …

Advocacy at a Glance

May 3, 2019

House Appropriations Subcommittees Begin FY 20 Bill Approvals. Three subcommittees of the House Appropriations Committee this week began the FY 20 “markup” process, … READ MORE …

Gains and Gaps in Knowledge about Shutdown Processes

April 19, 2019

In early January, the Alliance put out an “FDA shutdown toolkit” that was well received. We were working on a revised version when the shutdown (thankfully) ended. … READ MORE …

Advocacy at a Glance

April 19, 2019

Budget and Appropriations: Progress But No Clear Path Forward. The budget and appropriations situation was extensively briefed in last week’s Friday Update (here and more here) and Congress has been in recess since then. … READ MORE …

FY 20: The “Ask”; the Possible; and the Realities

April 12, 2019

Q:  We know that the late arrival of the President’s budget made it difficult to put together the Alliance’s FY 20 “ask.” Where did the Alliance finally come out?

A: The top-line; the Alliance is requesting $418 million in additional FDA programming for FY 20. Of that amount: $316 million is for medical products activities (the same amount as the President’s request) and $102 million is for food safety activities ($60 million above the President’s request). Our “ask” is built around a total number of dollars FDA needs and some general priorities for justifying that amount. We encourage Alliance members to support the Alliance “ask” and the general priorities we lay out. For Alliance members who are advocates for funding specific programs and initiatives within FDA, please utilize the Alliance position and supplement it with your own advocacy positions. The text of the Alliance “ask” is here. It is also described in slightly greater detail in the testimony that the Alliance submitted to the House and Senate Ag/FDA Appropriations Subcommittee. House testimony is here and Senate testimony is here.

Q:  Since January, every Alliance Q&A on the FY 20 appropriations process has said how difficult it is going to be. Are things getting any better?

A:  Maybe. One of the purposes of having Congress pass a joint budget resolution is that it provides top-line spending numbers (section 302(a)). Working within that amount, the appropriations committees then allocate a certain amount to each subcommittee (the often-cited 302(b) numbers). Sometimes House and Senate allocate different amounts to subcommittees, which can create a stumbling block to reaching agreement on specific appropriations bills. That pales in comparison to times when — in the absence of a budget resolution — the House and Senate adopt different 302(a) spending ceilings.

That’s where the FY 20 process (the current one) was heading and still may go. It is a very hopeful sign that Speaker Pelosi and Majority Leader McConnell are talking about a budget deal that might fix several impediments to a smooth FY 20 appropriations process. Presumably, they are looking for an agreement that would prevent the massive spending cuts that would be required by the spending limits in the Budget Control Act of 2011.  Also, it has been reported that House Appropriation Chair Nita Lowey has said that her committee staff are already working on setting 302(b)’s numbers so that subcommittees in the House can at least can get started.

Beyond that, we would hope they would agree on a common 302(a) spending number, so both House and Senate start allocating dollars to subcommittees using the same bottom line. A deal might also resolve how much defense spending will be placed under the Overseas Contingency Operations (OCO), which is designed to support the cost of military operations, i.e. wars, and does not count against spending ceilings. For purposes of agencies like FDA — that are part of the non-defense discretionary portion of the budget — there is a risk that routine DOD expenditures will get passed through the OCO and weaken efforts to keep non-defense growing by the same amount as defense.

Of course, there is no guarantee that a deal will be reached. Democrats and Republicans have different ideas on how to resolve their differences. But there will also be great pressure to find common ground and avoid further government disruption.

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

Advocacy at a Glance

April 12, 2019

Hearings on FDA’s Budget are Completed. What Next?  Both the House and the Senate have talked about accelerating schedules for FY 20 appropriations. The House leadership would like to have all 12 bills completed by July 1. Senate Appropriations Committee leadership has set as its goal getting all 12 bills out of committee by July 1. With the President’s request submitted to Congress and the Commissioner having testified before each of the subcommittees, the next step is subcommittee mark-up. The House usually goes first, but nothing prevents the Senate from marking up if they are ready to do so.

Congress is on recess for the next 2 weeks, so mark-ups won’t start before May. Historically, Military Construction/VA. Legislative Branch, and Defense are moved first, so the Ag/FDA mark-up is more likely to be mid-to-late May or early June. Also, there is strong sentiment to move Labor-HHS in tandem with Defense appropriations and eventually make them one bill. This was a successful tactic in the FY 19 cycle.

But Can Appropriations Move Forward Without a Budget Bill? The answer is yes, but the path is not an easy one. The most pressing issue is that the Budget Control Act would force more than $70 billion in defense cuts and more than $50 billion in non-defense cuts, relative to the final FY 19 levels. That isn’t going to happen and, reportedly, House Speaker Nancy Pelosi and Senate Majority Leader Mitch McConnell have agreed to begin talks on a 2-year budget bill that would re-set the caps to a level that Congress can accept. More about the current state of the budget process and implications for FDA are in this week’s Analysis and Commentary.

Thanks to All Who Attended the Last Two Alliance Events. This week, Anna Abram, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs, spoke to a large group of Alliance members. Her remarks covered a large number of FDA initiatives — and, as always, the number and breadth of FDA responsibilities is remarkable. In her speech, as well as in the question and answer session, she emphasized continuity. While Dr. Gottlieb will be missed, acting commissioner Sharpless has the same goals and Secretary Azar has also spoken about his commitment to policy and program continuity at FDA. At the end of March, the Alliance also had the honor of hosting one of Commissioner Gottlieb’s last public appearance as Commissioner. More than 100 Alliance members and media attended.

Dr. Sharpless Now Acting FDA Commissioner.  With Dr. Gottlieb’s departure on April 5, Dr. Ned Sharpless, NCI Director, has become Acting FDA Commissioner. He will serve until a new commissioner is nominated and confirmed. NCI is known to work more closely with FDA than many of the other NIH institutes, so he arrives with considerable knowledge about the agency and its responsibilities. At the time of his appointment as acting commissioner, the Alliance commented here.

Alliance Submits Testimony to Senate Ag/FDA Subcommittee. This week, the Alliance submitted its testimony for the record to the Senate Ag/FDA appropriations subcommittee. The testimony is here. More about the Alliance “ask” is contained in this week’s Alliance and Commentary.