Q&A - October 20, 2025
This week’s questions:
It appears that no progress has been made to end the federal government shutdown. What happens next?
There have been recent headlines that FDA’s FY 26 funding might be appropriated, separate from resolution of the shutdown. Is this true and how likely is it?
FDA has announced the first nine companies to be granted vouchers under the Commissioner’s National Priority Review Voucher Initiative. What do you think?
Q: It appears that no progress has been made to end the federal government shutdown. What happens next?
A: Shutdowns (real and threatened) are often resolved by the majority party assuring the minority party of 1/ future good faith negotiations on the core issue (in this case, subsidies for Affordable Care Act (ACA) premiums) and 2/ subsequent floor time to debate and vote.
This shutdown continues because the Democrats' don’t trust President Trump and the Republican leadership to follow through on such promises.
Since it is harder to negotiate trust than substance, the shutdown is unlikely to end soon. Note that both sides are treating this as a game of “who can hold their breath the longest,” instead of focusing on the substantial long-term damage to our nation. To an extent, the timing makes this possible--it is unlikely that this shutdown will be a factor in the next Congressional elections, which are a year away.
The shutdown will end when enough constituencies--important ones, at least--tell Congress that the shutdown is disrupting their lives and businesses.
The Democrats are hoping that moment comes at the end of October when approximately twenty-two million Americans will be informed of their new ACA insurance premium rates. With the loss of the health insurance subsidies provided by the ACA (aka Obamacare), many families will face ruinous increases in the cost of health insurance. It’s important to note that subsidies are used more frequently in Republican states and districts than elsewhere (Washington Post).
Another potential tipping point may occur when the SNAP program runs out of money to fund benefits. That is likely to occur in November and will affect nearly 42 million Americans in both red and blue states (Food Fix). Politico Agriculture (here) is a good source of ongoing information about how the lack of USDA funding during the shutdown affects farm and anti-hunger feeding programs.
Republicans are hoping they can ride out the shutdown by using leftover funds and tariff income to pay military salaries and keep certain popular programs going, such as the WIC feeding program. (Washington Post).
Q: There have been recent headlines that FDA’s FY 26 funding might be appropriated, separate from resolution of the shutdown? Is this true and how likely is it?
A: There is a possibility. However, the probability is quite low, so it shouldn’t be raising anyone’s hopes.
Three separate appropriations bills have passed both the House and the Senate and could be moved forward once negotiators resolve the differences between the House and Senate’s versions of the bills. One of those funding bills would provide FY 26 funding for USDA and FDA.
The Republican strategy is to get the bills passed as a mini-bus (three bills combined). If that fails because Democrats don’t agree, that will give them additional bases for casting blame for the shutdown on Democrats.
Whatever little hope that this strategy would move funding bills forward appears to have been diminished by the Senate defeat of a similar maneuver at the end of last week, intended to pass the bipartisan FY 26 Defense appropriations bill.
There is one other scenario that might involve movement on FDA funding. The House could choose to take up and pass the Senate-passed USDA/FDA funding bill (as a stand-alone, not part of a mini-bus). It would then be sent directly to the President for signature.
From a Republican standpoint, there would be several advantages: it would only require a majority vote in the House; it would provide funding for politically sensitive farm assistance and feeding programs; it would completely restore staffing at FDA food programs and at the USDA’s Food Safety and Inspection Service (shutdown impact analysis from Hogan Lovells).
A further explanation of the appropriations maneuvers can be found in this Politico article here.
Q: FDA has announced the first nine companies to be granted vouchers under the Commissioner’s National Priority Review Voucher Initiative (FDA Website). What do you think?
A: I have written about the program several times, most recently at here. This first batch has—at least for the time being—assuaged my primary concerns.
Here is what I told a Pink Sheet reporter:
“I have had two concerns about the CNPV: would the selections be made fairly; and whether the chosen products would be aligned with unmet medical needs. The first nine projects are encouraging. First, there is no obvious favoritism. Second, rhetoric about national priorities aside, each one can make a case for meeting an unmet medical need. The jury is still out on a third item: whether faster reviews are real or a by-product of cherry-picking and time-shifting some of the review steps from post-submission to pre-submission.”
Traditionally, FDA has used “unmet medical need” to focus on life-threatening conditions. With this voucher program, it is using a broader understanding of the meaning of the term. This has enabled a wider variety of products to be given vouchers. As a result, the staff burden of accelerated timeframes is being spread more broadly rather than concentrated in the Office of New Drugs.