The fox is guarding the henhouse.
Drug companies are imposing their own rules on the 340B drug pricing program — demanding extensive private patient claims-level data from safety-net hospitals and threatening to withhold legally required 340B discounts when hospitals don’t comply.
Some manufacturers are requiring hospitals to turn over millions of lines of claims data covering 340B prescriptions, including drugs dispensed through hospitals’ own pharmacies. Hospitals that don’t meet these manufacturer-created requirements can lose access to 340B pricing and be forced to pay substantially higher prices for medicines.
There’s one big problem: Congress never gave drug companies the authority to make these rules.
340B Is the Law — Not a Voluntary Drug Company Program
Congress created 340B to require participating drug manufacturers to provide discounted medicines to eligible safety-net hospitals and clinics.
The law does not give manufacturers the authority to impose sweeping new reporting requirements as a condition of receiving those discounts.
Yet manufacturers increasingly are acting as their own regulators — deciding what information hospitals must provide, determining whether they have complied, and imposing the penalty when they decide they haven’t.
Drug companies shouldn’t get to write the rules, police the rules, and punish hospitals under a program they are required to participate in.
The Consequences Reach Patients
When manufacturers withhold 340B pricing, safety-net hospitals must pay more for medicines — diverting resources that otherwise support patient care.
340B savings help hospitals maintain services that communities depend on, including cancer care, behavioral health services, rural care, specialty medications, and other services that might otherwise be difficult to sustain.
Every dollar unnecessarily taken away from these hospitals is a dollar that cannot be used to support patients and communities.
It’s Time to Enforce 340B
Congress wrote the 340B law. Drug companies don’t get to rewrite it.
The administration must enforce the 340B statute and stop drug manufacturers from conditioning access to legally required discounts on requirements Congress never authorized.
And Congress must hold manufacturers accountable and protect safety-net hospitals and the patients who depend on them.
Tell policymakers: Enforce 340B. Protect patient access.