Insights: Healthcare

Drug Pricing/Most-Favored Nation Pricing (MFN)

HHS has submitted a Notice of Proposed Rulemaking (NPRM) entitled “Global Benchmark for Efficient Drug Pricing (GLOBE) Model” – presumably outlining a CMS Innovation Center (CMMI) model testing MFN pricing – to the White House’s Office of Information & Regulatory Affairs (OIRA) for review. This is the final step before a regulation is formally...

Drug Pricing/TrumpRx (Direct-to-Consumer)

The Trump administration is considering creating a government-run website which would facilitate the purchase of certain pharmaceuticals by consumers at discounted cash prices – a direct-to-consumer (DTC) construct that would presumably bypass pharmacy benefit managers (PBMs) and/or insurance companies. The plan has not yet been finalized and is...

Pharmaceutical Tariffs

President Trump yesterday posted... "Starting October 1st, 2025, we will be imposing a 100% Tariff on any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America. “IS BUILDING” will be defined as, “breaking ground” and/or “under construction.”

Healthcare, Macro

Fiscal Year 2026 Funding/Government Shutdown, ACA

At the urging of Republican leaders, President Trump cancelled a meeting this week with Democratic leaders to address the need to pass appropriations legislation to fund government operations past the 10/1 beginning of FY26. If appropriations legislation is not passed by 9/30, government operations (e.g., discretionary programs such as...

Nutrition Policy/FDA

As part of the FDA’s recently unified agenda update (which outlines upcoming regulatory actions for the coming months) - and as called for in the MAHA Strategy Report released this week - the agency has signaled it will issue a proposed rule that (1) requires the mandatory submission of "generally recognized as safe" (GRAS) notices for substances...

Pharmaceutical Advertising

After months of inaction by HHS Secretary Kennedy and FDA Commissioner Makary regarding direct-to-consumer (DTC) pharmaceutical advertising - despite evidence of their intense focus on the issue - the administration is finally beginning to turn its attention to the matter.