Healthcare & Life Sciences: Drug Pricing Digest — Number 57

Inflation Reduction Act, Healthcare Reform, and General Developments

ADDITIONAL MANUFACTURERS ENTER INTO DRUG PRICING AGREEMENTS

A second major US pharmaceutical manufacturer announced on October 10, 2025, that it has entered into a drug pricing agreement with the Trump administration. The White House issued a fact sheet accompanying the announcement. 

Sources: The New York Times, The Washington Post, InsideHealthPolicy, Law360, BloombergLaw, BioWorld, StatNews.

Commenters noted possible ethical concerns regarding the involvement of the Food and Drug Administration (FDA) in negotiating the pricing deal.

Source: PinkSheet.

A third manufacturer announced its drug pricing agreement on October 16, 2025, and the White House again issued a fact sheet. 

Sources: StatNews, PoliticoPro, BloombergLaw, Law360, BioWorld. 

As with the first agreement, which we discussed in issue No. 56 of this digest, the terms of these agreements remain confidential, and both manufacturers agreed to participate in the TrumpRx website.

Check out Latham’s new report US State Regulatory Spotlight on Healthcare Transactions: Reflections From 2025, which provides key takeaways, analysis, and action items for investors, providers, payors, and other stakeholders, as well as an appendix detailing enacted legislative and regulatory developments in 13 states.

ADDITIONAL MANUFACTURERS ANNOUNCE DIRECT-TO-CONSUMER PROGRAMS

Two manufacturers have announced that they will make certain drugs available via direct-to-consumer (DTC) portals, as well as through the TrumpRx website. These companies join others that have recently announced DTC initiatives.

Sources: The Wall Street Journal, BloombergLaw, Reuters (first, second), PoliticoPro, InsideHealthPolicy, Scrip, CNBC.

FDA AWARDS NATIONAL PRIORITY VOUCHERS, CONSIDERS DRUG PRICING

On October 16, 2025, FDA announced that it has awarded vouchers to nine sponsors under the Commissioner’s National Priority Voucher (CNPV) program. We discussed the CNPV program in issues No. 50 and No. 51 of this digest. 

FDA stated in its announcement that each recipient “has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation [MFN] pricing.” One of the sponsors is the third manufacturer to enter into a confidential pricing agreement with the Trump administration, as discussed above.

FDA also stated that it “anticipates announcing another group of CNPV recipients in the coming months.”

Sources: InsideHealthPolicy, StatNews, Pink Sheet, BloombergLaw, BioWorld. 

STAKEHOLDERS DISCUSS INTERNATIONAL MFN IMPACTS

Stakeholders continue to discuss the potential impacts of the MFN drug pricing policy, including on ex-US markets.

Sources: StatNews, PoliticoPro, PinkSheet, BloombergLaw, Scrip.

TRUMP OFFICIALS PLAN “FUTURE OF PHARMACEUTICALS” SUMMIT IN DECEMBER

Donald Trump Jr. and senior Trump administration officials are planning to host a “Future of Pharmaceuticals” summit with leading pharmaceutical manufacturers. The invitation-only event will reportedly take place in Washington, D.C., in early December, and one topic is expected to be DTC sales programs.

Sources: The Wall Street Journal, The Washington Post.

IRA LEGAL CHALLENGES CONTINUE

Drug manufacturer litigation challenging the Inflation Reduction Act (IRA) drug pricing negotiation program continues.

Sources: BloombergLaw (first, second), Law360 (first, second), InsideHealthPolicy, BioWorld.

Medicaid Drug Rebate Program (MDRP)

340B Program

COVERED ENTITY CHALLENGE TO MANUFACTURER AUDIT DISMISSED

As reported in issue No. 49 of this digest, multiple covered entities filed litigation seeking to halt audits initiated by a manufacturer. Previously, those covered entities had filed an emergency appeal following the case’s dismissal. The covered entities have now filed a voluntary dismissal of their appeal.

Source: 340B Report.

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

Drug manufacturer litigation challenging the 340B laws enacted by various states continues.

Sources: Law360, 340B Report (first, second, third, fourth).

Medicare Part B

Medicare Part D

TRUMP ADMINISTRATION CLAIMS STAND-ALONE PART D PREMIUMS WILL DECREASE

The Centers for Medicare & Medicaid Services (CMS) issued a statement projecting a decline in average stand-alone Medicare Part D premiums for 2026. The agency also, for the first time, rejected certain stand-alone Prescription Drug Plan (PDP) bids it labeled as market outliers due to year-over-year premium increases, cost-sharing hikes, or benefit reductions. Some stakeholders warn that these bid rejections could further reduce PDP plan options and may push beneficiaries toward Medicare Advantage (MA) plans, especially where PDP choices are already limited. 

Sources: InsideHealthPolicy (first, second), Reuters.

State Law Developments

DRUG DISTRIBUTORS CHALLENGE CONNECTICUT PRICE CAP LAW

A trade organization representing drug distributors has brought a lawsuit challenging a Connecticut statute that would penalize price increases that outpace inflation. The law, Connecticut S.B. No. 11, as adopted in Bill No. 7287, is slated to become effective January 1, 2026. The price cap applies to “a brand-name drug … to which all exclusive marketing rights granted under the [Federal Food, Drug, and Cosmetic Act] … and federal patent law have expired for at least twenty-four months, including any drug-device combination product for the delivery of the brand-name drug,” and to “a generic drug or interchangeable biological product.”

Source: BloombergLaw.

CALIFORNIA WILL LAUNCH STATE-BRANDED INSULIN IN JANUARY

California Governor Gavin Newsom issued a press release on October 16, 2025, announcing that “California’s CalRx Insulin Glargine in pen form will be available to consumers for a suggested retail price of not more than $55 per five-pack of pens … beginning January 1, 2026.” This is the first initiative of its kind.

Sources: PoliticoPro, StatNews, BloombergLaw.

STAKEHOLDERS DISCUSS COLORADO PDAB’S UPL

Stakeholders are discussing the Upper Payment Limit (UPL) recently imposed by the Colorado Prescription Drug Affordability Board (PDAB). As reported in issue No. 56 of this digest, the Colorado action marks the first time a PDAB has imposed a UPL.

Sources: BloombergLaw, GenericsBulletin, Pink Sheet.