Q&A - October 06, 2025
This week’s questions:
How long is the shutdown likely to continue?
Did Commissioner Makary offer companies accelerated review if they make the pricing concessions requested by the Administration?
Where does the farm community fit into the MAHA agenda?
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Q: How long is the shutdown likely to continue?
A: Once a shutdown gains momentum, it becomes much harder to predict its conclusion. And the current shutdown has a lot of momentum.
While it is not hard to envision the substance of a compromise this year, it’s next to impossible to imagine a quick resolution. One viable option would be for Democrats to secure a four-year extension of the Obamacare premium subsidies rather than a permanent one. That would make the subsidies expire at the end of 2029, a year after the next Presidential election.
In turn, Republicans would receive some significant reforms to the program, but less than what they want. Such a compromise would address the substantive issues but would not address the underlying and substantial political power struggle.
I agree with Damian Paletta of the WSJ (article here) that this shutdown is less about the disagreement and more about the total lack of trust between the two parties. Many previously threatened shutdowns were resolved by a commitment from the majority party to negotiate in good faith and permit a floor vote on the outcome. (Another interesting read here from Karen Tumulty of the WP).
In this case, Democrats do not trust: 1/the Senate Majority Leader Thune or House Speaker Johnson to negotiate in good faith, 2/ the President not to veto the resulting legislation, or 3/ the Executive Branch not to negate the agreement by refusing to disburse Congressionally appropriated funds.
Nobody knows how to restore this trust. So, this shutdown is likely to last for an extended period. I am projecting at least two weeks (until October 13) and would not be surprised if it extended to more than a month (until November 5, the day after state and local elections).
Q: Did Commissioner Makary offer companies accelerated review if they make the pricing concessions requested by the Administration?
A: Not quite, but close enough to be of concern. Here is what he said, as reported by the Washington Post (here):
“In an announcement on drug pricing with Pfizer this week, FDA leader Marty Makary also dangled accelerated drug approvals as a potential reward for lowering prices or moving more manufacturing to the U.S. “If you equalize your price [with other wealthy countries], then we're going to put your future applications at the front of the line,” he said in Tuesday’s Oval Office briefing.”
Is he referencing the Commissioner’s National Priority Vouchers (CNPV)? Or is he suggesting something larger, less exclusive, and more transactional than the CNPV? Either way, it raises a serious concern: Is it ethical to exchange favorable review times for non-medical achievements?
Heretofore, access to a shorter review period has been premised on meeting some important unmet medical need.[1] One can quibble about whether any specific drug was denied a quick review unjustly or whether a particular drug received a quick review inappropriately....but the overall standard itself has always seemed unassailable.
On-shoring biopharmaceutical manufacturing and lowering drug prices are national goals, as well as Trump goals. They should not be FDA goals, except as relates to advanced manufacturing[2] and faster reviews of generics and biosimilars.
Awarding faster reviews for non-medical achievements is a betrayal of patients with unmet medical needs. Companies developing treatments for those patients should not find themselves pushed to the back of the queue (for agency attention and accelerated review times) by companies developing important but not groundbreaking therapies.
Notably, rewarding non-medical achievements grossly favors large companies with multiple marketed products, which have the cash flow and assets to reduce prices or finance on-shoring. Companies with no or only one or two products (often orphan drug companies) don’t have that flexibility.
Q: Where does the farm community fit into the MAHA agenda?
A: Earlier this year, the White House was treating the consumer-oriented Secretary of HHS as more politically important than the agriculture-oriented Secretary of Agriculture. This was a serious misjudgment, particularly given the strong farm-state support that the President received in 2016, 2020, and 2024.
One result was that the initial MAHA report, released in May, showed no particular interest in farm issues or appreciation of the vital role that farmers play. This set in a counter-reaction—HHS and USDA held MAHA meetings with a wide variety of farm stakeholders over the summer (described here in the WSJ).
Farmers applauded the September report—notably the direct attack on pesticides had disappeared, replaced by more general language. Consumer groups were unhappy (some quite unhappy) with the softer stance. A Washington Post story, published this morning, provides more detail (here)
Notwithstanding the rift this has exposed, it is a positive development that farmers are now part of the dialogue. MAHA will not achieve anything of value if the process isn’t more inclusive, fosters serious conversation, and gains buy-in to negotiations and compromises. Making food policy without including farmers was always a misguided approach.
[1] Certain vouchers can be used to obtain shorter review times for drugs that are not special. However, the vouchers are tied to a previous act that advanced an important, previously unmet medical need.
[2] Enhancing advanced manufacturing, an FDA goal, can encourage on-shoring. However, it is an FDA goal because FDA’s current good manufacturing practices (cGMP) standards can, unintentionally, discourage manufacturing innovation.
[1] Certain vouchers can be used to obtain shorter review times for drugs that are not special. However, the vouchers are tied to a previous act that advanced an important, previously unmet medical need.
[2] Enhancing advanced manufacturing, an FDA goal, can encourage on-shoring. However, it is an FDA goal because FDA’s current good manufacturing practices (cGMP) standards can, unintentionally, discourage manufacturing innovation.