Summary
Tennessee enacted the FAIR Rx Act, banning pharmacy benefit manager-owned pharmacies from operating in the state. Express Scripts and the PCMA filed separate lawsuits in June 2026 to block the law. As a result, the future of specialty pharmacy distribution in the US is now a live legal question. Moreover, nine other states are developing comparable legislation.
Access Impact
The law targets a structural feature of US drug distribution: PBMs that own the pharmacies they direct patients toward. Express Scripts warns its Memphis dispensing facility — holding $900 million in drug inventory daily and serving nearly half a million patients — would be forced to close. However, the market access implications extend beyond Tennessee. Specifically, if courts uphold such laws across multiple states, the specialty pharmacy infrastructure supporting high-cost therapies faces a coordinated dismantling. For drug developers, the Care-Pathway Integration dimension of market access risk has become directly relevant.
Care-Pathway Integration
Specialty pharmacies owned by PBMs have become the primary US channel for biologics, rare disease treatments, and other high-cost therapies. These facilities manage cold chain logistics, patient support programs, and payer reimbursement — often as a single integrated function. Consequently, fragmentation of PBM-pharmacy ownership would require manufacturers to rebuild their US distribution infrastructure. Furthermore, formulary positioning agreements that bundle pharmacy placement with reimbursement terms would need to be renegotiated under a new structural model.
Evidence Quality and Robustness
Market access assessments for US launches have typically assumed a stable specialty pharmacy distribution model. However, that model is now contested. The legal arguments involve ERISA preemption and the Dormant Commerce Clause — neither resolved in this context. Notably, a similar Arkansas law was challenged successfully by the same PBMs last year. Therefore, drug developers cannot assume that the US distribution landscape in 2028 will resemble the one used to build current access plans.
Residual Uncertainty and Equity
Federal regulators have confirmed that PBMs pay their own pharmacies preferential reimbursement rates, contributing to independent pharmacy closures. The FAIR Rx Act responds directly to that finding. Even so, if the law forces PBM-owned specialty facilities to close, access to certain therapies could narrow before it improves — particularly for patients in markets where independent alternatives are limited. The equity dimension is real on both sides of this dispute.
Risk Signal
The question is not whether PBMs will win in court. It is whether drug developers have assessed their US access risk against a distribution structure that may not exist in 2028. At least nine states are revisiting the same model. If formulary control and distribution ownership separate, the access pathway for specialty therapies changes — and so does the reimbursement landscape attached to it. How many US market access plans account for a structural disruption of this scale?
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