Healthcare & Life Sciences: Drug Pricing Digest — Number 53

Inflation Reduction Act, Healthcare Reform, and General Developments

STAKEHOLDERS REACT TO MOST FAVORED NATION POLICY

The Trump administration has not released additional details regarding the most favored nation (MFN) drug pricing policy since publicly posting letters to 17 pharmaceutical manufacturers, which we discussed in issue No. 52 of this digest. Some manufacturers have taken actions in response to the MFN policy, and stakeholder discussions of the issue continue.

Sources: Scrip, Pink Sheet (first, second), InsideHealthPolicy, PoliticoPro, 340B Report.

IRA POLICY DISCUSSIONS CONTINUE

Stakeholders continue to discuss how the implementation of the Inflation Reduction Act’s (IRA’s) maximum fair price requirement, which will apply to the first 10 selected drugs beginning in 2026, may affect the pharmaceutical industry.

Source: StatNews.

Medicaid Drug Rebate Program (MDRP)

No developments to report. 

340B Program

MANUFACTURER CHALLENGE TO STD CLINIC CERTIFICATION STANDARDS MOVES FORWARD

Three drugmakers filed suit in December 2024 challenging the standards and process employed by the Health Resources and Services Administration (HRSA) for certifying sexually transmitted disease (STD) clinics as eligible for 340B. The manufacturers allege that the agency unlawfully permitted certain clinics to participate in the program. On August 4, 2025, Chief Judge James E. Boasberg of the US District Court for the District of Columbia denied the government’s partial motion to dismiss, holding that the manufacturers need not exhaust administrative remedies and that their claims are not moot. The court explained that the manufacturers are challenging HRSA’s overarching certification standards, not any single site’s status, so the dispute remains active even if particular clinics move in or out of the 340B program.

This manufacturer lawsuit relates to the Nevada covered entity litigation we discussed in issues No. 43, No. 44, and No. 50, but takes a different posture. In that case, also before Chief Judge Boasberg, a covered entity challenged HRSA’s termination of eight STD clinic sites from the 340B program. The court ruled on June 27, 2025, that HRSA acted lawfully in terminating those sites, though HRSA nonetheless reinstated them, effective July 1, 2025. By contrast, the manufacturers are not defending HRSA’s termination decision but instead challenging the agency’s underlying framework for determining which STD clinics qualify for 340B in the first place. The August 4 ruling allows that broader challenge to proceed on the merits.

Possibly in response to the manufacturer litigation, HRSA published an information collection request in the Federal Register pursuant to the Paperwork Reduction Act. The notice indicates that HRSA is changing the information that STD clinics must provide when registering for the 340B program or recertifying. As proposed, these entities (as well as tuberculosis clinics) will have to provide documentation evidencing that they receive federal grants.

Sources: InsideHealthPolicy, 340B Report. 

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

Lawsuits challenging the 340B laws enacted by various states continue.

 Sources: 340B Report (first, second, third).

Medicare Part B

No developments to report.

Medicare Part D

No developments to report.

State Law Developments

COLORADO PDAB POISED TO IMPOSE FIRST PAYMENT CAP

Stakeholders are voicing concerns as the Colorado Prescription Drug Affordability Board (PDAB) is considering imposing a state-wide health insurance payment cap on a drug. This action would be the first of its kind in the US.

Source: BloombergLaw.

MARYLAND PDAB SELECTS “UNAFFORDABLE” DRUGS

The Maryland PDAB has named certain drugs as “unaffordable” and will proceed to vote on setting an upper payment limit for these drugs. Stakeholders are concerned that these actions may result in unintended consequences.

Sources: InsideHealthPolicy (first, second).