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Patient advocates explain why they oppose MFN and BIO tells why it supports PAHPA. (979 words, 3 minutes, 55 seconds) |
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BIO Coffee Chat: Patient groups oppose MFN pricing plans |
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Patient groups are registering opposition to proposed Most Favored Nation (MFN) pricing because it would reduce access to innovative new medicines without lowering costs, advocates told BIO’s Patient Advocacy Coffee Chat.
The proposals: The Centers for Medicare and Medicaid Innovation (CMMI) is considering proposals to limit prices Medicare pays for prescription drugs based on prices paid in other countries.
Harming affordability: As Sue Peschin, Alliance for Aging Research CEO, explained, CMMI itself projected that, for Medicare Part B alone, healthcare costs for seniors will increase $3.6 billion, primarily due to increased cost-sharing responsibility. She said pharmacy benefit manager (PBM) reform is the real solution.
Threatening America-first access: “Most new drugs first launch in the U.S.” thanks to the American approach, said Olivia Backhaus, Aimed Alliance staff attorney. “Major OECD countries often experience delays of almost a year or more.”
Importing discriminatory QALYs: Other countries use Quality Adjusted Life Years (QALYs) formulas—banned by Medicare for effectively giving lower value to lives of people with disabilities. “Importing foreign price controls from these countries imports their discriminatory health assessment practices,” said Thayer Roberts, Partnership to Improve Patient Care (PIPC) Director.
BIO’s view: “The proposals were not designed with patient concerns in mind—they do NOT address affordability for patients and, in fact, risk exacerbating access barriers,” said Karin Hoelzer, BIO Senior Director for Patient Advocacy. BIO supports simplifying the system to control costs driven up by middlemen.
What’s next: BIO and these patient groups are filing comments on the proposals with the CMMI. The comment deadline is today.
Read full coverage on Bio.News.
Read more: Simplify the system. |
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BIO submits comments for PAHPA preparedness legislation |
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BIO advocates national security protections through reauthorization of a robust Pandemic All-Hazards Preparedness Act (PAHPA) in comments submitted to lawmakers last week.
Why it matters: PAHPA ensures readiness for public health emergencies like pandemics and bioterrorism. It was fully reauthorized with bipartisan support twice since its 2006 launch, but many provisions expired in 2023.
Latest development: Reps. Neal Dunn, MD (R-FL) and Lori Trahan (D-MA) issued a request for information asking what the reauthorized PAHPA should contain.
BIO’s recommendations included:
BIO’s view: “PAHPA underpins the public-private collaboration that keeps our nation prepared for emerging biological threats. A strong, fully authorized framework is essential to maintaining readiness, protecting Americans, and sustaining U.S. leadership in biotechnology innovation,” says Phyllis Arthur, BIO EVP, Chief of Global Health.
Read the full submission here. |
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Administration to continue investigating tariffs on pharmaceuticals. Following the Supreme Court’s Feb. 20 decision that broad tariffs were not justified by the International Emergency Economic Powers Act, President Trump set temporary 15% global tariffs under Section 122 of the Trade Act of 1974. While pharmaceuticals and pharmaceutical ingredients were exempt from the President’s latest tariffs, the Administration launched an investigation in spring 2025, under Section 232 of the Trade Expansion Act, to determine whether pharmaceutical tariffs are justified. The findings of that investigation are still awaited. Meanwhile, the U.S. Trade Representative announced on Feb. 20 the Administration would initiate investigations under Section 301 of the Trade Act of 1974, including an investigation of pharmaceutical pricing practices, “on an accelerated timeframe.”
BIO Board Member Bradley Campbell will testify in the Senate about improving FDA regulation of rare disease treatments.The Feb. 26 hearing at 9:30 a.m. “will explore how regulatory processes and evolving standards at the Food and Drug Administration (FDA) can unintentionally delay patient access to safe and effective therapies, particularly for individuals living with rare diseases,” says a Senate Special Committee on Aging announcement. “Members and expert witnesses will share the life-altering impacts of these delays on patients and their families,” and “explore opportunities to improve regulatory clarity and predictability.” Campbell is President & CEO of Amicus Therapeutics, a biotech focused on developing rare disease treatments. Watch the hearing here.
Casey Means, MD, U.S. surgeon general nominee, has a Senate confirmation hearing Feb. 25. Means was originally scheduled to appear before the Health, Education, Labor & Pensions (HELP) Committee in October but the hearing was delayed as she went into labor with her first child. Watch the hearing here.
BIO marking Rare Disease Day. BIO will be lighting up its DC offices as part of the Global Chain of Lights campaign to mark the day on Feb. 28. BIO recently celebrated some progress, with this month’s reauthorization of the Pediatric Priority Review Voucher (PPRV) program, but there are more challenges to address. Watch for further coverage of Rare Disease Day in Bio.News.
Ahead of BIO’s BIG Summit, a venture capitalist explains patient-centric investment. The March 2-3 Biotechnology Innovation Organization (BIO) Investor Growth (BIG) Summit will address investment and other issues facing the biotech industry, while providing unique partnering opportunities. As Nicole Schwerbrock, Associate Director at IBD Venture Investments, explains to Bio.News, advocacy-driven investment models can act as a symbiotic balance to traditional venture capital. Read more on Bio.News.
Senate HELP Committee report calls for FDA reform. A Feb. 17 report released by the Senate Health, Education, Labor & Pensions (HELP) Committee recommends improvements to the Food and Drug Administration (FDA) to make review of drug candidates more predictable, reduce clinical trial barriers, modernize regulatory pathways for rare disease treatments and cell and gene therapies, and add expert staff. BIO President & CEO John F. Crowley urged similar improvements in his Feb. 11 testimony before the House Energy & Commerce Health Subcommittee, saying “We need a modernized and reformed FDA, and the core of that has to be the leadership and the staff.” Read more here. |
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