Nov 10, 2026 · 28 min
Midterms Put FDA Leadership and Drug Pricing in Play
Ep. 397 - What the U.S. midterms mean for biopharma
The election fallout could reshape public-health oversight and pricing policy while a failed pelacarsen trial challenges confidence in Lp(a) therapies.
- 1Prolonged acting leadership could preserve routine FDA reviews while increasing political pressure on vaccines and other sensitive areas.
- 2Pelacarsen sharply reduced Lp(a) but failed to improve cardiovascular outcomes, weakening the case for the target in secondary prevention.
- 3Argenx’s $550 million acquisition adds oral and macrocyclic peptide technology to its antibody-focused platform.
Don't miss
Pelacarsen’s full readout showed substantial Lp(a) reduction without meaningful cardiovascular efficacy, challenging the target’s development path.
The brief
BioCentury analysts Steve Usdin and Lauren Martz examine how the midterms could alter FDA and HHS leadership, vaccine oversight, drug pricing, and biopharma strategy.
An acting FDA commissioner may keep product reviews moving through the agency’s divisions, but prolonged temporary leadership could invite greater political influence over vaccines and policy.
Pelacarsen substantially lowered Lp(a) yet failed to produce meaningful cardiovascular benefit across tested subgroups, leaving earlier prevention and genetically extreme levels as open questions.
At the Society for Immunotherapy of Cancer meeting, researchers presented ways to localize treatment in solid tumors, including engineered bacteria, modified monocytes, and in vivo CAR-T approaches.
Argenx’s acquisition of Unnatural Products brings a macrocyclic and oral-peptide platform that could complement its antibodies and support an oral analogue of Vyvgart.
What was said on this episode
24 statements · 7 positive · 13 negative · 2 mixed · 2 neutral
Heidi Overton is unlikely to be confirmed as FDA commissioner.
“I think that it's unlikely now that Heidi Overton will be confirmed as FDA commissioner.”
Listen at 5:39
FDA likely will lack a confirmed permanent commissioner for the rest of Trump’s administration.
“The most likely outcome is there will not be a confirmed permanent commissioner, I think, for the rest of the Trump administration.”
Listen at 6:44
Acting FDA leadership will face more direction from HHS and the White House.
“there's going to be more direction from the HHS secretary, from the White House, from Stephen Miller. and from others in the White House”
Listen at 9:03
An acting FDA commissioner will be less able to resist political influence.
“the acting FDA commissioner will lack the statute to be able to resist political and ideological influence on the agency.”
Listen at 9:11
An acting FDA commissioner cannot block policies opposed by FDA staff.
“An acting FDA commissioner is not going to be able to intervene if and when the HHS secretary or the White House tries to get policies put in place that FDA staff oppose.”
Listen at 10:38
Acting FDA leadership is unlikely to disrupt operational product reviews.
“I think that it's unlikely to affect things on the operational level.”
Listen at 11:20
FDA efforts on first-in-human trials and rare-disease regulation likely will continue.
“those things are likely to proceed apace.”
Listen at 12:06
Vaccines may face greater approval or labeling difficulty under acting FDA leadership.
“it may be more difficult for vaccines, for example, to get approved or to get the kind of labels that they want under a scenario with an acting commissioner”
Listen at 12:21
The midterm results make Robert F. Kennedy Jr.’s continued tenure more likely.
“This certainly makes it more likely that he will.”
Listen at 12:44
Democrats likely will summon pharmaceutical CEOs to testify.
“They're likely to call CEOs of drug companies to testify at hearings.”
Listen at 14:23
Democrats will subpoena pharmaceutical companies’ MFN agreements.
“They're certainly going to subpoena. the MFN deals that companies did.”
Listen at 14:27
Democrats want MFN principles used to set Medicare-negotiated drug prices.
“The Democrats want to use MFN as the tool for setting prices. that are negotiated under Medicare drug price negotiation”
Listen at 14:55
President Trump likely would sign MFN drug-pricing legislation.
“there's a very good chance that President Trump would sign it.”
Listen at 15:16
Bipartisan legislation may apply international reference pricing to Medicare negotiations.
“there's a possibility that it could be around drug pricing and it could be around applying most favored nation principles, international reference pricing to Medicare drug negotiation”
Listen at 15:35
Pelacarsen showed no efficacy across tested trial subgroups.
“Pella-Carson really didn't show any efficacy at all against any of the subgroups that were tested in this trial.”
Listen at 18:02
Pelacarsen reduced Lp(a) by approximately 80%.
“this was about 80%.”
Listen at 19:07
Lp(a)-lowering therapy may work when used earlier or for primary prevention.
“this may work if you use it in a primary prevention setting or much earlier.”
Listen at 19:21
Further large early-intervention Lp(a) trials are difficult to fund.
“who's going to fund an even bigger, even earlier study in the same mechanism? It's hard to envision that path forward.”
Listen at 20:05
Lp(a) remains biologically plausible but lacks a clear development path.
“I'm not ready to give up on it, but I don't know that there is a drug development path forward for it.”
Listen at 21:15
Late-stage Lp(a) therapies may produce similarly disappointing outcomes.
“it's hard to see a different outcome coming for the other, at least the other therapies that are in the late stage testing now.”
Listen at 22:15
New solid-tumor immunotherapies target immunosuppression and systemic immune toxicity.
“they're trying to overcome two of the biggest challenges in cancer immunotherapy for solid tumors, which are the immunosuppressive tumor microenvironment and the systemic toxicities related to activating the immune system.”
Listen at 23:04
Nonspecific CAR integration may cause secondary cancers.
“They don't integrate the car into a specific site in the DNA, which we know can be a problem. It can potentially cause secondary cancers, things like that.”
Listen at 25:17
Site-specific CAR integration could become an important in vivo CAR-T approach.
“there are a few companies and academic groups now that are showcasing site-specific car integration for their in vivo car teas, which I think is something that could end up being very interesting.”
Listen at 25:28
Argenx and Unnatural Products are pursuing an oral Vyvgart analogue.
“They're basically trying to create an oral Vivgart with unnatural.”
Listen at 27:00
Statements are attributed to the speaker as said on the episode and reflect their view at the time, not PodLume's. They are not advice.
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