Newsletter
Healthcare & Life Sciences: Drug Pricing Digest — Number 69
April 6, 2026
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law.
Inflation Reduction Act, Healthcare Reform, and General Developments
TRUMP ISSUES PROCLAMATION ON SECTION 232 TARIFFS
On April 2, 2026, President Trump issued a proclamation stating that the Secretary of Commerce has completed an investigation under Section 232 of the Trade Expansion Act of 1962 and concluding that “it is necessary and appropriate to adopt a plan of action … to adjust … imports of pharmaceuticals and associated pharmaceutical ingredients so that such imports will not threaten to impair the national security of the United States.”
Among other things, the proclamation:
- Imposes “a 100 percent ad valorem duty rate on the import of patented pharmaceuticals and associated pharmaceutical ingredients” and states that “the ad valorem duty rate be 20 percent on imports of patented pharmaceuticals and associated pharmaceutical ingredients produced by companies that have plans, approved by the Secretary, to onshore production of such pharmaceuticals and pharmaceutical ingredients,” with the lower rate increasing “to 100 percent 4 years after the date of this proclamation.”
- Provides “that it is necessary to implement pharmaceutical-related commitments in existing trade deals with the European Union, Japan, the Republic of Korea, and Switzerland and Liechtenstein jointly, as well as a future pharmaceutical-related deal with the United Kingdom,” and states that “the ad valorem duty rate for patented pharmaceuticals and associated pharmaceutical ingredients … shall be 15 percent for products of Japan, the European Union, the Republic of Korea, and Switzerland and Liechtenstein jointly” and that “the tariff rate on patented pharmaceuticals and associated pharmaceutical ingredients for products of the United Kingdom shall be 10 percent and then reduce to zero to the extent required by any future agreement.”
- States that there will be “no tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients produced by companies that have fully executed agreements or are negotiating agreements with the Secretary and the Secretary of Health and Human Services regarding [Most Favored Nation (MFN)] pricing and onshoring of production and R&D of patented pharmaceuticals and pharmaceutical ingredients.”
- Explains that “generic pharmaceuticals and their associated ingredients shall not be subject to tariffs pursuant to section 232 at this time.”
The proclamation indicates that the tariff rate is zero for orphan-designated drugs, as well as for specific categories of drugs, such as “nuclear medicines; plasma derived therapies; fertility treatments; cell and gene therapies; [and] antibody drug conjugates.”
Sources: InsideHealthPolicy, Stat News (first, second), PoliticoPro, Law360, BloombergLaw, Pink Sheet (first, second, third).
US, UK PRICING AGREEMENT FINALIZED
The “agreement in principle” that the US and UK reached on December 1, 2025, has been finalized. We discussed the agreement in principle in issue No. 60 of this digest.
Commenters continue to discuss the ex-US impacts of the MFN drug pricing policy.
Sources: PoliticoPro, Pink Sheet, Reuters (first, second), The Guardian.
TRUMP RELEASES BUDGET PROPOSAL
On April 3, 2026, President Trump issued his budget proposal for fiscal year 2027. The proposed budget would cut funding for federal health agencies by approximately 12%.
Sources: Stat News, PoliticoPro, InsideHealthPolicy (first, second, third).
TRUMP ADMINISTRATION PROMOTES DRAFT MFN LEGISLATION
The Trump administration has reportedly drafted legislation that mirrors the MFN deals that 16 major pharmaceutical manufacturers have entered into. The administration is sharing the draft legislation with specific manufacturers in an effort to garner industry support for the measure.
Sources: Washington Post, Stat News, Pink Sheet.
FDA ANNOUNCES CNPV PUBLIC HEARING
On March 23, 2026, the Food and Drug Administration (FDA) published a notice in the Federal Register that the agency will hold a public hearing regarding the Commissioner’s National Priority Voucher (CNPV) program. We discussed the CNPV program, which FDA had announced in June 2025, in issues No. 50 and No. 51 of this digest. The hearing will be held on June 12, 2026, and is intended “to obtain feedback and perspectives regarding the CNPV Pilot Program, including feedback on the eligibility criteria, voucher selection processes, sponsor responsibilities, FDA review procedures, and program implementation.”
Source: InsideHealthPolicy.
IRA LEGAL CHALLENGES CONTINUE
Drug manufacturer litigation against the Inflation Reduction Act (IRA) drug-pricing negotiation program continues.
Sources: BloombergLaw, InsideHealthPolicy.
Medicaid Drug Rebate Program (MDRP)
No developments to report.
340B Program
DISTRICT COURT STRIKES DOWN GPO PROHIBITION POLICY
On April 1, 2026, the US District Court for the District of Columbia struck down as arbitrary and capricious guidance from the Health Resources & Services Administration (HRSA) regarding the group purchasing organization (GPO) prohibition. The 340B statute requires certain covered entity types to “not obtain covered outpatient drugs through a [GPO] or other group purchasing arrangement” when participating in the 340B program. HRSA issued the guidance in 2013.
Sources: BloombergLaw, 340B Report.
MANUFACTURER CHALLENGE TO HRSA CERTIFICATION PRACTICES CONTINUES
Litigation brought by manufacturers challenging the 340B eligibility of certain sexually transmitted disease (STD) clinics continues. The manufacturers allege that HRSA permitted these STD clinics to participate in the 340B program and certified their eligibility without satisfying all statutory requirements. We discussed this litigation in issue No. 43 of this digest.
Source: BloombergLaw.
REBATE MODEL LITIGATION AND DEVELOPMENTS
Litigation regarding the 340B rebate model continues at the appellate level.
Source: BloombergLaw.
MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE
Drug manufacturer litigation challenging the 340B laws enacted by various states continues.
Sources: InsideHealthPolicy, Law360 (first, second), BloombergLaw, 340B Report (first, second, third, fourth).
The US Court of Appeals for the Fourth Circuit sided with manufacturers in their challenge to West Virginia’s contract pharmacy law.
Sources: BloombergLaw, Law 360, 340B Report (first, second).
ADDITIONAL STATES ADOPT CONTRACT PHARMACY LAWS
More states have enacted or proposed legislation that would bar drug manufacturers from restricting contract pharmacy access. Some bills would require covered entities to make disclosures regarding 340B discounts. We note that legislative action related to the 340B program may have occurred in other states but has not yet been reported in the trade press.
Source: 340B Report (first, second, third, fourth)
Medicare Part B
No developments to report.
Medicare Part D
CMS ISSUES FINAL RULE TO CODIFY IRA PART D REDESIGN
The Centers for Medicare & Medicaid Services (CMS) issued a final regulation to codify changes to the Part D program implemented by the IRA, as well as to formalize aspects of the manufacturer discount program that replaced the coverage gap discount program. The final rule addresses other aspects of Medicare as well.
Sources: BloombergLaw, InsideHealthPolicy.
State Law Developments
No developments to report.
Endnotes
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