Trump pharmaceutical enforcement decisions are back in federal court because two drug policies drew separate legal challenges. One case froze a 340B discount change, while the other allowed cannabis rescheduling to move forward during review.
The 340B program requires drugmakers to sell outpatient drugs at capped prices to safety-net hospitals and clinics. TransparentRx describes those hospitals and clinics as the affected group because they would have bought pilot drugs at full price first. Patients did not pay rebates directly, but clinic budgets faced new cash-flow strain.
Table of Contents
- Why the 340B rebate pilot was frozen
- Why cannabis rescheduling is also in court
- Who pays more or waits longer right now?
- What courts have left undecided?
Why the 340B rebate pilot was frozen
Chartis reported that HRSA issued a July 31, 2025 notice creating a 340B Rebate Model Pilot in its pilot analysis. The pilot covered ten Medicare-negotiated drugs. It let manufacturers pay 340B pricing as post-purchase rebates instead of upfront discounts. A JD Supra summary of the ruling says the U.S. District Court for the District of Maine granted a preliminary injunction on Dec. 29, 2025.
The court found HRSA failed to consider and explain the rebate impact as the Administrative Procedure Act requires. Bloomberg Law reported that the First Circuit denied an emergency stay on Jan. 7, 2026 in its stay-order report, blocking Jan. 1 implementation. Feldesman Leifer reported that HRSA then withdrew the 2025 notice. Approved manufacturers must continue offering all covered outpatient drugs at the 340B ceiling price as an upfront discount.
Why cannabis rescheduling is also in court
Cannigma reported that President Trump issued a Dec. 18, 2025 executive order directing expedited cannabis rescheduling in its rescheduling overview. Acting Attorney General Blanche then issued an April 23, 2026 order. It moved FDA-approved products and state-licensed medical marijuana to Schedule III effective April 28, 2026. Mondaq analysis says the D.C. Circuit consolidated three petitions on May 29, 2026. The cases include a drug-testing association, Smart Approaches to Marijuana, and an MMJ and provider coalition in Nos.
26-1130 and 26-1136. MMJ International Holdings said it joined June 2, 2026, citing competitive disadvantage after years pursuing FDA approval, according to its ACCESS Newswire release. Marijuana Moment reported that a three-judge D.C. Circuit panel denied opponents' stay request on Sept. 9, 2026 in its ruling report. The court found they failed the stringent stay-pending-review test. Rescheduling proceeds while merits litigation continues, and the panel also denied intervention by two medical-marijuana companies.
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Who pays more or waits longer right now?
TransparentRx identifies safety-net hospitals and clinics as the group facing new paperwork and delay under the pilot model. They would have paid full wholesale price upfront and filed new claims-data submissions.
A small clinic with tight cash flow would feel that delay first. Use these checks now:.
- If you use a 340B clinic pharmacy, ask whether your drug was among the ten pilot drugs.
- If you work at a covered entity, confirm your wholesaler still applies upfront 340B discounts.
- If you use medical marijuana, confirm your product's status with your state medical program.
What courts have left undecided?
Healthcare Dive and MJBizDaily note an important limit behind both orders. The 340B injunction is preliminary. The rescheduling stay denial only addresses interim harm.
That means upfront 340B discounts remain in place for now. Schedule III status for medical cannabis also remains in place for now. Track D.C. Circuit merits briefing and any new HRSA notice before changing purchasing or compliance plans.
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