Amgen’s Restrictive 340B Policy – 10-16-2025

On September 2, RWC-340B sent a letter to Amgen’s CEO objecting to Amgen’s unilateral decision to refuse to honor 340B pricing for STD clinics.

• The Policy: Amgen claimed it is not required to sell drugs at 340B prices to STD-designated covered entities, asserting its products are not indicated for STDs.
• Why It’s Wrong: This position violates the 340B statute, HRSA guidance, and Amgen’s PPA. Once a patient is eligible at an STD clinic, the clinic may provide any necessary 340B drug—not just those tied to STD treatment.
• Public Health Impact: STD rates are rising sharply, particularly in the South. Amgen’s policy deprives clinics of critical resources, undermines patient care, exacerbates the public health crisis of increasing STDs, and is inconsistent with FDA labeling for some Amgen products that require STD testing prior to use.
• Implementation Concerns: Amgen dictated this policy change informally via emails to wholesalers, applied it retroactively, and denied chargebacks—leaving STD clinics in some cases with hundreds of thousands of dollars in uncompensated costs.

Our Demand: RWC-340B called on Amgen to rescind this dangerous policy immediately and repay affected clinics for its refusal to provide 340B discounts. HRSA was copied on the letter to ensure oversight and corrective action.

RWC-340B will continue to engage aggressively with CMS, HRSA, and drug manufacturers to defend the integrity of the 340B program for the patients and communities we serve.