President Donald Trump issued a new Executive Order aimed at reducing drug prices for American patients, directing the Department of Health and Human Services (HHS) to take significant steps. The Order calls for a revamp of the Medicare Drug Pricing Negotiation Program, introduced by President Joe Biden under the Inflation Reduction Act, with a focus on equalizing the treatment of small-molecule prescription drugs and biological products during negotiations.
Key Directives
The Order addresses several critical areas:
- Medicare Drug Pricing Negotiation: Small-molecule drugs will now receive the same negotiation terms as biologics, ending the previous disparity where small-molecule drugs became eligible after 9 years compared to biologics’ 13-year window.
- Medicaid Drug Pricing: The HHS is tasked with exploring price reductions for Medicaid drugs used by seniors but excluded from negotiation scopes.
- Transparency in Drug Pricing: Enhanced transparency is mandated regarding the role of middlemen, including pharmaceutical benefit managers (PBMs).
- Accelerated Approval of Generics and Biosimilars: Plans to expedite the approval of generics, biosimilars, and combination products are to be developed.
- Anti-Competitive Behavior: The Justice and Commerce departments are directed to draft recommendations to reduce anti-competitive practices in the pharmaceutical industry.
Impact on the Pharma Industry
The Order is expected to have significant implications for the pharmaceutical industry, particularly in addressing pricing disparities and fostering competition. By aligning Medicare payments with actual hospital drug costs and requiring health centers to lower prices for insulin and injectable epinephrine for low-income patients, the administration aims to provide immediate relief to vulnerable populations.-Fineline Info & Tech
