On August 4, the Federal Trade Commission (FTC) and Department of Justice (DOJ) convened their third and final listening session as part of implementing President Trump's Executive Order (EO), Lowering Drug Prices by Once Again Putting Americans First.1 This session, shorter than the previous two and featuring only one panel, focused on synthesizing insights from earlier discussions and identifying actionable strategies to make medications more affordable and accessible for Americans.
The panelists, consisting of Republican policymakers and experts from Capitol Hill, identified several significant issues impacting drug affordability and patient access. A major concern expressed was the unintended consequence of health care regulations initially designed to ensure patient safety, which have evolved into barriers delaying the entry of generic and biosimilar drugs into the market. Panelists called for targeted, bipartisan regulatory reforms aimed at simplifying administrative processes, thus enabling faster approvals and market entry for more affordable treatments.
Another central discussion revolved around the criticisms of pharmacy benefit manager (PBM) practices that appear to prioritize PBMs' financial interests over patient affordability. Panelists argued that PBMs often direct patients toward higher-cost branded medications to maximize their profits, thereby inflating overall drug prices. Legislative proposals like the PBM Reform Act and Patients Before Monopolies Act were highlighted as potential solutions. These legislative proposals are designed to eliminate conflicts of interest, enhance pricing transparency, and restrict PBM practices such as spread pricing and vertical integration with pharmacies.2
The patent system was another focus area, with panelists emphasizing the patent system being essential for incentivizing pharmaceutical innovation, yet susceptible to manipulation that stifles competition. Practices like "patent thickets," where manufacturers secure numerous overlapping or minimally varied patents to extend exclusivity periods, and "product hopping," where manufacturers with a brand-name drug approaching patent expiration introduce a new reformulated version of the drug to shift patient prescriptions away from the older, generic-facing version, were identified as major obstacles that delay the introduction of generics and biosimilars. Panelists recommended closer collaboration between the FDA and the Patent and Trademark Office, stronger enforcement of patentability standards, and streamlined litigation procedures. They also advocated protecting competitive mechanisms, such as patent challenge processes, and clarified rules around skinny labeling, which enable generics to market their drugs without infringing on existing patents.
In discussing biosimilar drugs specifically, the panelists highlighted their potential to substantially lower health care costs. They endorsed the Biosimilar Red Tape Elimination Act (S. 1954), a bipartisan proposal that seeks to expedite the Food and Drug Administration (FDA) approval process for these medicines. Panelists stressed the necessity of resolving current patent litigation inefficiencies to fully unlock the competitive advantages biosimilars offer.
Additionally, panelists highlighted international disparities in pharmaceutical pricing, pointing out that U.S. consumers bear disproportionately high drug costs due to unequal global contributions toward pharmaceutical innovation. They suggested adopting fairer trade policies and encouraging international collaboration to distribute these costs more equitably.
Finally, the DOJ and FTC's firm stance on antitrust enforcement was reaffirmed, noting ongoing investigations and legal actions addressing anticompetitive behavior within the pharmaceutical industry, particularly targeting PBM practices and patent-related abuses. Panelists viewed these regulatory actions as critical to creating a fairer and more transparent pharmaceutical market.
While several bills have been introduced in Congress with bipartisan support to implement many of these policy proposals, it remains to be seen whether there is a path forward for bipartisan legislation in the current Congress.
Footnotes
1. Manatt on Health subscribers can see the April 21 edition of Insights This Week for more on the executive order.
2. Manatt on Health subscribers can see the July 14 edition of Insights This Week for more on the PBM Reform Act, and the Manatt on Health analysis for other PBM-Related policy proposals considered last Congress.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
