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from FY 19 spending on foreign aid programs and the UN was proposed by the Administration and now appears to have been withdrawn.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

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