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A flurry of congressional activity brings hope of 340B reform. Meanwhile, BIO comments on clinical trial reform. (665 words, 2 minutes, 40 seconds)
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Congress shows renewed interest in 340B reform |
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Recent developments in Congress indicate renewed appetite for reforming the 340B program, which drives up patient costs for prescription drugs.
Why it matters: Originally intended for underserved areas, 340B is supposed to provide patients in need access to free or discounted drugs and healthcare services. Unfortunately, some providers and middlemen now reap big profits from the program without helping patients, experts explain at BIO 2026.
In the House: The SECURE 340B Act, introduced July 6 by Reps. Scott Peters (D-CA) and John Joyce, MD (R-PA), attempts to return the 340B program to its original goals; it requires providers to give some discounts to those in need. It also “pauses manufacturer rebate models for four years while a new patient definition is created and standards for contract pharmacies, data sharing, and transparency take effect.”
In the Senate: Sen. Bill Cassidy, MD (R-LA) on June 29 put up a draft of his “340B for Patients Act” for comments. The act is intended to “ensure the Program is actually benefiting low-income and uninsured patients” and “prevent gaming of the program.”
The House Ways and Means Committee on July 1 advanced H.R. 9504, the Tax-Exempt Hospital Transparency Act, designed to prevent abuse by hospitals that take advantage of 340B rebates without really serving needy patients.
What they’re saying: “When the (340B) program started 34 years ago, there were two nonprofit hospitals participating,” per Rory Martin of IQVIA in a BIO 2026 panel on 340B. “Today, there are 2,000, and the sheer size and scope of the program is distorting the entire U.S. healthcare system.” |
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Faster clinical trials keep American biotech competitive |
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As the U.S. seeks to maintain its biotech leadership, we need to speed early stages of drug development, including first-in-human clinical trials.
Why it matters: “Continued erosion of Phase 1 trials in the U.S. could lead to reduction in the number of later-stage U.S. clinical trial activities,” and restrict Americans’ access to innovative new drugs, says a recent paper by the Reagan-Udall Foundation sponsored by BIO.
A legislative solution proposed by Rep. Jake Auchincloss (D-MA) supports innovations like point-of-care clinical trials—letting patients in regular health care settings join clinical trials, to enable efficiencies, improve patient access, and allow tests of multiple interventions. BIO’s recent comments on the proposal support point-of-care trials.
A hearing this week before the House Energy & Commerce Health Subcommittee will “examine how the U.S. can maintain leadership in biomedical innovation through efforts to streamline FDA's current drug development and clinical trial requirements.”
BIO’s view: “To maintain global competitiveness and preserve patient access to promising new medicines, the United States must strengthen support for cutting-edge R&D,” says BIO’s announcement of the Reagan-Udall Foundation paper. “That starts with removing barriers and actively incentivizing the early-stage trials that lead to breakthrough therapies.” |
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Study: Policy changes will curtail innovation by more than 50%. A new report from Magnolia Market Access finds that a combination of policy changes—a lack of research funding, regulatory staffing uncertainty, drug pricing proposals, and others—could significantly slow the pace of innovation, ultimately reducing the number of new treatments coming to market by up to 55% over the next two decades. Read more on Bio.News. |
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