The Federal Trade Commission (FTC) recently previewed forthcoming action in its crusade against pharmacy benefit managers (PBMs) and their affiliated group purchasing organizations by announcing a stay in its litigation against Caremark and Optum Rx while settlement discussions progress. The case – stemming from a 2024 administrative complaint alleging the artificial inflation of insulin list prices and cost-shifting those increases onto patients – has already reset health policy baselines through the FTC’s sweeping February consent agreement with Express Scripts and related companies. Yet what looks like pragmatic dispute resolution is, in reality, a distorted way to make national health policy choices through closed-door litigation and settlement rather than through more public legislative or notice-and-comment rulemaking processes.

The proposed Express Scripts consent agreement makes the distinction clear. The settlement is not a narrow injunction tailored to address a discrete practice. The market concentration may warrant scrutiny. But scrutiny is not the same thing as using a single enforcement action to rewrite core features of contracting and benefit design. While the Caremark and Optum Rx settlements are still being formulated and the Express Scripts consent agreement is still pending final approval, the proposed remedies show why this policy-by-settlement path is so problematic. The proposed order would last 10 years and place the company under a monitor for three years after implementation. It would require a “standard offering” under which patient out-of-pocket costs are capped at net cost rather than list price; push plan sponsors away from rebate guarantees and spread pricing; require point-of-sale pass-through of rebates in the standard offering; delink manufacturer compensation from list prices; mandate drug-level and claim-level reporting plus disclosure of broker compensation; create a new payment model based on actual acquisition cost plus a dispensing fee and compensation for non-dispensing services; and even require Express Scripts to move its group purchasing organization, Ascent, from Switzerland to the United States. Whatever one thinks of those individual ideas on the merits, this is not ordinary, case-specific relief. It is industry-shaping policy.

The FTC’s messaging on the Express Scripts consent agreement reinforces the point. In announcing that deal, it described the resultant settlement not merely as a remedy for alleged insulin-related misconduct, but as a vehicle for “significant wins for the broader Trump-Vance healthcare agenda,” including reshoring parts of Express Scripts’ business, improving price transparency compliance, disclosing payments to brokers, and paving the way for participation in TrumpRx. That is a candid acknowledgment that the agency sees the settlement as a policy instrument, not simply as a means of resolving a past dispute. If that same template is now being extended to CVS Caremark and Optum Rx, the FTC is further rewriting federal PBM law through opaque, negotiated orders.

That is precisely what should concern policymakers. Major changes to rebate treatment, spread pricing, pharmacy reimbursement, broker disclosures, and patient cost-sharing rules should be debated in public, on the record, with input from employers, plans, pharmacies, manufacturers, clinicians, and patients. Legislation and notice-and-comment rulemaking exist for a reason: They force the government to articulate a general theory, solicit broad feedback, evaluate tradeoffs, and apply rules prospectively across the market. A consent agreement does something very different. The FTC negotiates behind closed doors, accepts the deal subject to final approval, allows a 30-day comment period, and then may finalize an order that carries the force of law for future conduct. That is a thinner and more irregular substitute for actual policymaking.

There is also a deeper accountability problem. Settlements let regulators claim sweeping reform without fully litigating the merits of their policy and legal theory. They let respondents avoid the risk of an adverse ruling while self-selecting the rules that will govern them. But everyone else in the market is left to live under a quasi-regulatory framework that was negotiated behind closed doors. If CVS Caremark and Optum Rx now settle on Express Scripts-like terms, the country will get sweeping policy change without a real adjudication of the legal and economic questions that supposedly justified the intervention in the first place. That is an awkward and ineffective way to govern a market this large and this important.

None of this means PBM practices should escape reform. Instead, this potential reform should occur through regular policy channels. The wrong answer is to let litigation become a stand-in for lawmaking. Another FTC consent agreement with CVS Caremark and Optum Rx would not just settle a case. It would further normalize health policy by decree.