Selected Developments in Biotechnology Law and the Biotechnology Industry

HHS Plan(s) for Government Shutdown Show Priorities

By the time you read this, the U.S. federal government shutdown that occurred on September 30, 2025, will (hopefully!) be long resolved, but agency planning for the shutdown, even if it does not actually take effect or is reversed once the standoff is ended, provides a roadmap to agency priorities.

In the case of the Department of Health and Human Services (HHS), those priorities do not include the Centers for Disease Control and Prevention or the National Institutes of Health, which would have to furlough, respectively, two-thirds and three-quarters of their staffs. Functions to be severely curtailed include grant reviews, laboratory work, clinical work, contractor oversight, public information and messaging, and coordination with state health departments.

The U.S. Food and Drug Administration would fare much better, retaining 86% of its staff, so drug review and approvals would (mostly) continue during a shutdown. The Centers for Medicare and Medicaid Services would retain a bit more than half their staffs under the contingency planning, with an eye toward continuing their payments for eligible Americans’ medical needs.

Again, by the time you read this, the funding crisis will hopefully be over, and we’ll see how the planned cuts resembled what was in fact done, and what the lasting impact has been.

I. TRUMP EPA PITTING FARMERS VERSUS REFINERS

Biofuel is a priority of the agricultural industry, since farmers produce the feedstock for it. It was also a priority for prior administrations, which looked to increase biofuel usage to reduce carbon emissions. In particular, the mandate to blend ethanol into gasoline and produce biodiesel was cheered by farmers, since billions of gallons of biofuel—and therefore vast quantities of crops—were involved.

At the same time, the biofuel mandates were a thorn in the side of refiners, since producing biofuel and blending ethanol into gasoline is more costly than producing 100% fossil fuels. Essentially, the interests of farmers and refiners are opposed.

The current Administration is not green- or renewable-energy friendly, and disputes climate change as being a hoax or nonissue; it’s also closely aligned on many topics with the fossil fuel industry. That has already played out with the granting of numerous (more than 140, out of approximately 170 requests) exemptions for small refineries to allow them to opt out of producing biofuel due to the cost of doing so.

The question then becomes: what happens to the millions of gallons of biofuel the small refineries no longer need to produce? Are they reallocated to the larger refiners, to keep the total volume of biofuel constant, which helps farmers but increases the costs for those big refineries? Or will the total volume of biofuel to be produced be reduced, sparing larger refineries added costs but also significantly reducing demand for the feedstock crops, such as corn, barley, and sugarcane?

What to do next is being debated in the Administration—whether to keep volume constant and relocate the burden among refineries or whether to reduce the volume. Whatever the result, it’s certain that one group or another will be disappointed:

“This is a critical moment and EPA’s chance to uphold the president’s promise to fight for U.S. farmers and expand domestic fuel production,” said the CEO of the National Oilseed Processors Association, Devin Mogler.

II. HHS WINDS DOWN mRNA VACCINE DEVELOPMENT

HHS Secretary Robert F. Kennedy Jr. announced that “BARDA”—which is the Biomedical Advanced Research and Development Authority—“is terminating 22 mRNA vaccine development investments.” In making this announcement, he said they are “listen[ing] to the experts,” but did not actually cite any mass of peer-reviewed or broadly accepted research or expert opinion in support of the wind-down. As Kennedy has long been a vaccine skeptic, even a denier, and promotes various “alternative” health treatments and theories, the wind-down is hardly unexpected.

The 22 projects he mentioned involve $500mm of investments in mRNA vaccine development. Existing contracts are being canceled, pre-award solicitations are being terminated, and ongoing work in other contracts is being de-scoped. No new mRNA-based projects will be approved. The impact will go beyond the contracts or effects directly affected, since the loss of this investment will have a ripple effect on the universities and companies now receiving less funding.

III. U.S. ARMY INVESTING IN BIOMANUFACTURING

Good news for the biotechnology industry is that the U.S. Army is investing in a domestic biomanufacturing facility and researching how to forward deploy biomanufacturing in conflict zones and on the battlefield. The goal is to produce materials—such as the base for explosives and propellants—domestically, instead of having to import them from abroad, and to, in the future, be able to replenish consumables, such as fuel and ammunition, in-theater during conflicts, thereby reducing the threat of critical supply lines being cut. For example, in the event of a future war in the Indo-Pacific area, far from the U.S. home front and close to likely belligerents, it would clearly be advantageous to be able to produce rapidly expended consumables if not fully onsite, at least from closer bases and staging areas.

That, however, is the future—the military is not at the point of being able to produce or replenish supplies at the point of conflict. Currently, however, it has been able to expand U.S.-based production of materials which might otherwise have to be imported, with a renovated and expanded Biomanufacturing Pilot Facility at the Aberdeen Proving Ground in Maryland. Presently, the Pilot Facility can produce certain needed materials in quantities of up to 1,000 liters, but is hoping to scale that to 20,000, even 30,000 liters in the not too distant future.