In a razor-thin vote of 215-214 largely along party lines, the House of Representatives approved President Donald Trump's comprehensive tax reform legislation on Thursday. The bill, officially titled the "One Big Beautiful Bill Act," will now advance to the Senate for consideration.
Pharmaceutical Industry Impacts
The legislation contains several provisions affecting the pharmaceutical sector, particularly regarding drug pricing and market dynamics. Notably, the bill modifies aspects of the Biden administration's drug price negotiation program established under the Inflation Reduction Act (IRA).
One key change exempts orphan drugs approved for multiple rare diseases from the government's price negotiation process. If enacted, this modification would take effect in 2028, potentially benefiting pharmaceutical companies with diversified rare disease portfolios.
The legislation also addresses pharmacy benefit managers (PBMs) by prohibiting "spread-pricing" practices. This common industry tactic involves PBMs charging payers like Medicare more for medications than they reimburse to dispensing pharmacies, pocketing the difference as profit.
Pill Penalty Remains Unchanged
Despite expectations to the contrary, the bill does not address the controversial "pill penalty" - the significant disparity in negotiation exclusion periods between small-molecule drugs (typically pills) and biologics under the IRA. President Trump had previously signaled support for eliminating this disparity through an executive order issued last month.
The current framework provides biologics with 13 years of market exclusivity before being subject to government price negotiations, while small-molecule drugs receive only 9 years. This discrepancy has been criticized for potentially discouraging investment in traditional pill-based medications.
All House Democrats and two Republicans voted against the tax bill.
MAHA Report Released
Concurrent with the House vote, the White House published its nearly 70-page "Make America Healthy Again" (MAHA) report outlining health policy priorities for the Department of Health and Human Services. The document focuses heavily on addressing what it terms a "childhood chronic disease crisis."
The report takes aim at what it describes as the "overmedicalization" of children, expressing concern about medication overprescription and attributing this trend to "conflicts of interest in medical research, regulation, and practice."
Pharmaceutical Industry Scrutiny
The MAHA report specifically targets the pharmaceutical industry's influence on regulatory bodies, describing a "corporate capture and revolving door" dynamic within U.S. health systems. It notes that from 1998 to 2018, the pharmaceutical industry outspent all other sectors on federal lobbying.
"We must face the troubling reality that the threats to American childhood have been exacerbated by perverse incentives that impact the regulatory bodies and federal agencies tasked with overseeing them," the report states.
Vaccine Schedule Concerns
The report also raises questions about the "growth of the childhood vaccine schedule." While acknowledging that immunizations protect children from infectious diseases, it suggests that potential side effects "must be balanced against their benefits."
Proposed Initiatives
To address these concerns, the MAHA report recommends establishing enhanced post-marketing surveillance mechanisms to monitor real-world safety outcomes. It also advocates for studies examining "long-term neurodevelopmental and metabolic outcomes" associated with commonly prescribed pediatric medications.
As the tax bill moves to the Senate, healthcare stakeholders will be watching closely to see if additional pharmaceutical provisions, particularly regarding the pill penalty, might be introduced during further deliberations.
