The “One Big Beautiful Bill Act” includes negotiation exemptions for orphan drugs approved to treat more than one rare disease and has implications for PBMs. Also on Thursday, the White House released its MAHA report with a mission to “make our children healthy again.”
Voting 215–214 almost entirely along party lines, the House of Representatives on Thursday signed off on President Donald Trump’s sweeping tax reform bill, which will now move on to the Senate.
The proposed legislation, dubbed the “One Big Beautiful Bill Act,” offers certain modifications to the Biden-era drug price negotiation program created under the Inflation Reduction Act. For instance, Trump’s tax bill excludes orphan drugs approved to treat more than one rare disease from negotiations. These changes will take effect in 2028, if the bill passes into law.
Trump’s One Big Beautiful Bill Act also puts some limits on pharmacy benefit managers, prohibiting a common practice called spread-pricing, referring to when these pharma middlemen charge payers—like Medicare—more for a drug than they pay the pharmacies that dispense the medications, and keeping the difference as profit.
Conspicuously missing from the act, however, are adjustments to the pill penalty—the difference in the negotiation exclusion period for small-molecule drugs versus the period for biologics. Last month, Trump signaled his support for removing this penalty with an executive order. All Democrats and two Republicans voted against Trump’s tax bill.
Also on Thursday, the White House released its nearly 70-page MAHA report, which outlines policy priorities for the Department of Health and Human Services. The report “provides [the] foundation” for the Department’s mission “to make our children healthy again” and address what it calls the “childhood chronic disease crisis.” According to the White House’s website, the report will also help the government “lead a coordinated transformation” of the U.S. “food, health, and scientific systems.”
Meanwhile, the MAHA report, despite its focus on food and nutrition, targets what it brands as the “overmedicalization” of children. “There is a concerning trend of overprescribing medications to children,” the report reads, blaming this pattern on “conflicts of interest in medical research, regulation, and practice.”
One of the main culprits, according to the report, is the “corporate capture and revolving door” of the U.S. health systems. “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,” it reads. The pharma industry is named in particular, which according to the report from 1998 to 2018 spent more on federal lobbying “than any other industry.”
The MAHA report also flagged the “growth of the childhood vaccine schedule.” While it concedes that immunization “benefits children by protecting them from infectious diseases,” it claims they also come with side effects “that must be balanced against their benefits.”
To address these issues, the report recommends several initiatives, including launching a robust post-marketing surveillance mechanism for real-world safety findings and supporting studies that assess “long-term neurodevelopmental and metabolic outcomes” of common drugs prescribed for children.
