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CR-Level Funding at Start of FY 20 Approaches Certainty

September 13, 2019

Congress is back and the FY 20 funding situation has evolved. … READ MORE …

Advocacy at a Glance

September 13, 2019

Senate Appropriations to Mark-Up Ag/FDA Bill on Tuesday, September 17.  The subcommittee mark-up for Ag/FDA funding is now slated for 3:00 p.m. on Tuesday, September 17. Although not yet scheduled, it is assumed that the full committee will include the bill at mark-up on September 19.  If so, there is a strong possibility that Ag/FDA will be bundled into a minibus with the other three bills likely to emerge from subcommittee next Tuesday: Military Construction/VA, Financial Services, and the Transportation/HUD bill

The Alliance’s Recess Projections Borne Out by Initial Congressional Actions on Funding Bills.  Our last two columns, “What Can Go Wrong?” (August 23, here) and “What Needs to Go Right?” (September 6, here), assessed the complicated political and policy situation as Congress moves to complete FY 20 appropriations bills. This week’s Analysis and Commentary updates our analyses based on Congress’ first week back.

Congress Focused on Continuing Resolution (CR) While Still Trying to Move Funding Bills Forward. With a dwindling number of days before the end of the fiscal year, the House plans to move forward next week on a Continuing Resolution that would continue to fund the government, probably through Thursday, November 21 (another date could still be chosen). House leadership has declared an intent to produce a “clean CR,” which, in this case, means a bill that (1) does the minimum needed to keep the government funded, (2) is politically saleable to the Senate and the President, and (3) avoids a government shutdown on October 1. At week’s end, the House was still working on final details in advance of next week’s vote.

Senate Sets Ambitious September Schedule with Mixed Results Thus Far. The Senate Appropriations Committees plan was to mark-up four funding bills on October 12, four more on October 19, and the final four on October 26.

For a number of strategic and political reasons, the DOD and L-HHS bills were intended to be in the first wave and became the anchor of a minibus that could possibly be on the President’s desk by September 31. While still not impossible, the goal to enact the first minibus this fiscal year was slowed, if not derailed, when the Committee postponed the L-HHS mark-up. Allegedly, the unresolved issues involved disagreements on so-called “poison pill” riders, but Minority Leader Schumer focused his explanation on the need to be sure that L-HHS (the first non-defense bill being considered) was not shorted by billions of dollars that would be used to fund substantial increases at Homeland Security (likely one of the last non-defense bills to be considered).

The War of the 302(b) Allocations: Senate-Adopted Numbers Leave House and Senate Far Apart.  The Bipartisan Budget Act (BBA) set the FY 20 non-defense funding, in the aggregate, at about 4% above FY 19 levels. The Senate succeeded in getting subcommittee 302(b) allocations approved by assuring HHS’s increase was comparable, on a percentage basis, to the overall increase. Still unresolved is how the House will adjust its 302(b) allocations, given that its bills aggregate to $15 billion more in non-defense spending than the BBA levels. So, for example, the House allocation for Agriculture/FDA is about $1.2 billion more than the Senate and for Labor/HHS it is about $4 billion more. The House will have to accept downward adjustments, but not necessarily aligned with the Senate 302(b) levels.

FDA Forges Ahead with State Cooperative Agreement on Produce Safety. The Produce Safety Rule, one of the major planks of the Food Safety Modernization Act, continues to be implemented nationwide. Last week, FDA signed a 5-year cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to work together on implementation and educational activities. FDA Fact Sheet — Association Produce Cooperative Agreement Program

Much to Gain from a Smooth Appropriations Process

September 6, 2019

In our last Analysis and Commentary (on August 23), we explored the question, “What could possibly go wrong?” … READ MORE …

Advocacy at a Glance

September 6, 2019

Congress Returns September 9/10 to Hectic Fall, Including Funding Bills. The Hill newspaper’s headline characterized the situation well: “Congress is set for a chaotic fall sprint.” … READ MORE …

Sometimes Things Just Don’t Go as Planned (or Hoped)

August 23, 2019

We are grateful that Congress passed the Bipartisan Budget Act (BBA) before August recess, setting more realistic budget ceilings. … READ MORE …

Advocacy at a Glance

August 23, 2019

Appropriations Bills Face Unknown Fate in September. The August 9 Analysis and Commentary laid out the case for both an optimistic and a pessimistic view of the FY 20 appropriations process in September.  At least based on published reports, little has occurred since then to alter the delicate balance between the two views. We assume that appropriations committee staff are hard at work … but such behind-closed-doors activities are scrupulously kept from the public eye to discourage a horde of reporters and lobbyists descending on busy staffers.

Building on the earlier commentary, this week’s Analysis and Commentary looks at potential complications that will need to be resolved — if not in September, then certainly after October 1. A whole or partial government shutdown is close to unthinkable, but can’t be ruled out. Beyond that, there are a lot of unproductive outcomes with greater levels of probability than a shutdown. FDA will certainly feel the consequences if its appropriations bill isn’t passed.

CBO Projects Increasing Federal Budget Deficits; Tax and Spending Skirmishes Continue. CBO announced revised projections this week, showing a likely trillion-dollar deficit in FY 20 and rising deficits for at least three more years after that. Meantime, with Congress out of town, the Administration has been exploring what it can do to reduce total spending and adjust priorities within the federal budget. A well-publicized effort to shrink $4 billion from FY 19 spending on foreign aid programs and the UN was proposed by the Administration and now appears to have been withdrawn. Similarly, a trial balloon was floated that would have reduced federal revenue by creating a temporary cutback in payroll taxes and an effort to inflation-adjust capital gains. By week’s end, those seem to have lost momentum, as well.

Former Commissioner Califf Opines on FDA’s Role and the Need for a Well-Funded Agency. In an essay in STAT, former FDA Commissioner Robert Califf discusses the interplay of scientific complexity, quality by design, and trust between the agency and sponsors. While not everyone will agree with everything he has written, we were struck by his repeated emphasis on a well-funded agency. He wrote:

[FDA] must have adequate funding in order to maintain a talented workforce with deep knowledge of the relevant medical products, quantitative expertise, and highly specialized clinical and scientific judgment.

He also states:

… we need a well-funded FDA that provides independent oversight on the methods, data, analysis, and claims about data. While the current system has served us well, major issues need to be addressed to ensure that we improve oversight to accommodate an increasingly complex, multidimensional scientific environment.

FDA Science Forum on September 11-12, Entitled “Transforming Health: Innovation in FDA Science.” One of the best opportunities to see how FDA views its own contributions to regulatory science and innovation is the FDA Science Forum, held every two years. This year’s topics are: Precision Health; Advanced Technology; Product Accessibility, Integrity and Security; Predictive Tools; Advancing Digital Health and Artificial Intelligence; Outbreak!; Addiction; and Empowering Consumers, Patients, and Other Stakeholders. The agenda and registration are now available.

Friday Update Will Not Publish August 30; Back to Weekly Starting September 6.  Today’s issue provides a mid-recess look at budgeting and appropriations. After a week off, we will return on September 6 to discuss the status of appropriations efforts and politics just before Congress returns. We will be back to a weekly schedule after that.

Angling for Optimism

August 11, 2019

Measured by the number of days to the start of the new fiscal year (about 50)READ MORE …