Pharma Firms Left Out of Trump Drug Deals Seek Entry

Drugmakers excluded from the Trump administration’s latest drug-pricing agreements are lobbying for inclusion, fearing competitive disadvantage and formulary exclusion.

A growing number of pharmaceutical manufacturers excluded from the Trump administration’s latest round of voluntary drug-pricing agreements are aggressively lobbying the Department of Health and Human Services for entry. The deals, brokered directly between HHS Secretary Robert F. Kennedy Jr. and a select group of CEOs, lock in substantially lower list prices for certain high-cost Medicare drugs in exchange for preferred formulary placement and protection from import competition.

Companies left at the negotiating table now fear significant competitive disadvantage. Being outside the agreements means their products may face higher patient copays, stricter utilization management, or outright exclusion from formularies managed by pharmacy benefit contractors aligned with the administration’s push. Several mid-tier manufacturers have retained D.C. lobbying firms specifically to request a second window for negotiations.

“This is creating a two-tier market,” said a pharmaceutical access strategist. “Those inside the deal secure volume and predictability. Those outside face an uncertain path to patients.” The administration has not committed to expanding the program, with Secretary Kennedy stating the initial round “captured sufficient savings.”

The agreements represent a sharp departure from traditional Medicare drug price negotiation, which operates through statutory timelines under the Inflation Reduction Act. Instead, HHS has used its administrative authority to solicit direct, binding price commitments in exchange for regulatory incentives. Legal experts note the novel approach has so far avoided court challenges, unlike the IRA’s mandatory negotiation program.

Analysts suggest excluded companies are preparing to offer deeper rebates or launch competing “biosimilar-like” versions of blockbuster drugs to regain access. Meanwhile, pharmacy benefit managers are closely monitoring which manufacturers gain entry, as it will directly inform 2027 formulary construction. The window for inclusion remains uncertain, but industry pressure on HHS is intensifying weekly.