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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from FY 19 spending on foreign aid programs and the UN was proposed by the Administration and now appears to have been withdrawn.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 …

Advocacy at a Glance

August 11, 2019

BBA Becomes Law; Difficult Path to Appropriation Bills by October 1. The Bipartisan Budget Act of 2019 (BBA) is now law, setting budget ceilings for defense and non-defense spending for this coming fiscal year and next. Passage of the BBA is the necessary first step for enactment of FY 20 appropriations bills, but there is still a difficult path ahead and limited time. On paper, the situation looks fairly good. The House has passed 10 of the 12 appropriations bills already and the Senate is poised for accelerated action once they return on September 9.

However, the ink is barely dry on the President’s signature and the Senate is already staking out territory that will make compromise with the House difficult. The initial disagreement (and there are likely to be many more) is over the Labor-HHS funding bill. The media is reporting that Senate Appropriations Chairman Shelby intends to redirect $5 billion of monies allocated for L/HHS programs to border security (including a wall). This will provoke the House, which wants neither border wall funding nor a Homeland Security funding bill without restraints on unilateral executive branch action.

Analysis and Commentary Looks at Optimism vs. Pessimism about Passage of Funding Bills by October 1. In last week’s Analysis and Commentary (here), we expressed some (very) cautious optimism that movement on Senate appropriations bills in September would be sufficient for many agencies to be funded on October 1. They would then not need to be included in a Continuing Resolution when the fiscal year starts. In this week’s Analysis and Commentary, we compare the case for optimism and pessimism for appropriations action in September.

Multiple New Studies Highlight Real-World Costs of Major Diseases. Over the last two months, several studies have highlighted the costs associated with major diseases. Each represents a contribution to the literature that shows the value of FDA and the importance of  its contribution to fighting disease. The costs to society and Medicare of osteoporosis is described here and was sponsored by Alliance member, Research!America.  The costs of Alzheimer’s disease are described here and here and were sponsored by Alliance member, Alliance for Aging Research. New cost estimates on Parkinson’s disease are here and were sponsored by Alliance member, Michael J. Fox Foundation for Parkinson’s Research.

New Regulations Assure a Busy Summer. Hat tip to Nick Florko at STAT for finding this tidbit from a recent PwC analysis: Over the last 10 years HHS has dropped more regulations in July and August than virtually any other month of the year. Friday was among the most popular days to drop regulations.

Friday Update to Publish August 9 and August 23, Back to Weekly Starting September 6. It may be August in DC, but there is still plenty happening, especially around budgeting and appropriations. After today’s issue, we are going to take a week off and publish a mid-recess edition on August 23. We will take another week off (August 30). Then, on September 6, we will discuss the status of appropriations efforts and politics just before Congress returns. We will be back to a weekly schedule after that.

From Budget Deal to FY 20 Appropriations: Reasons for Optimism?

August 2, 2019

The budget deal was necessary for a successful FY 20 appropriations process, but not sufficient. … READ MORE …

Advocacy at a Glance

August 2, 2019

Budget Deal Passes Senate, President Agrees to Sign. The Bipartisan Budget Act of 2019 (BBA; a.k.a. “the budget deal”) passed the Senate this week by a vote of 67-28. It will next go to the President for his signature. The budget deal — several difficult months in the making — unblocks the appropriations process in time for some spending bills to become law by October 1. However, it doesn’t guarantee that result. Congress returns from August recess on September 9 and 10 and will only have about 3 weeks before the start of the new fiscal year. Senate markups are expected to start immediately upon return. If past schedules are any indication, subcommittees will mark-up on Tuesdays and those bills will be in full committee on Thursdays. Reportedly, the Senate will start with a minibus package with DOD, HHS, and a third bill, probably Energy and Water.

BBA Non-Defense Cap Allows Growth Over FY 19, But Less Than House FY 20 Numbers. In order to get started on appropriations bills without a budget deal, the House “deemed” a top-line spending number and allocated a portion to each subcommittee. As a negotiating tactic, the House numbers were intentionally high. So, to the surprise of no one, the non-defense spending caps in the BBA are significantly above FY 19 funding levels, but below the House levels. As a result, the Senate bills may be better or worse than the House for specific accounts, but the aggregate in the Senate bill will need to be about $15 billion less for non-defense programs.

Between Now and October 1: A Lot Needs to Happen. This week’s Analysis and Commentary discusses what Congress needs to do so that many/most appropriations bills — especially Ag/FDA — can be completed before October 1.  We are surprisingly optimistic.

Budget Caps Will End After FY 21: What Happens Then? After a decade of dealing with the constraints of the Budget Control Act of 2011, the latest budget deal eliminates budget caps and sequestration, starting with FY 22. When the next Congress meets in January 2021, they may return to the once-successful process of creating an annual Congressional Budget Resolution or may look for overarching budget deals like the current one. Alternatively, House and Senate could work on separate spending bills with different bottom lines and reconcile later in the process.  Roll Call explores the possibilities here.

Dr. Sharpless Sets Out His Priorities, Including Staffing. On July 23, Acting Commissioner Ned Sharpless sent FDA employees an e-mail outlining his top priorities (described here by Regulatory Focus). Those are: (1) assuring public health through emerging technologies; (2) investing in FDA’s next generation expert workforce and infrastructure; (3) modernizing frameworks; and (4) promoting and protecting consumer and patient safety. The Alliance is particularly pleased with his focus on investing in expert workforce and infrastructure. FDA can only be as good as the staff who serve.

FDA and USDA Food Leadership Discuss Agency Agendas. FDA Deputy Commissioner Yiannis appeared with his USDA counterpart to discuss food safety priorities at each agency. His comments (covered by Food Safety News) focused on his four most immediate challenges: fresh produce safety, combating Cyclospora, intentional adulteration, and food imports.

A Budget Deal Seems to Be in Place … But There Are More Questions

July 26, 2019

Q: Does the budget deal transition Congress from macro budgetary issues to micro budgetary issues? … READ MORE …