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Today, we have a recap of hearings and a markup on Capitol Hill, which advanced important PBM and 340B legislation, among other bills. Plus, it’s Global Accessibility Awareness Day—we tell you why it matters and how you can be a better advocate. (840 words, 4 minutes, 12 seconds) |
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Capitol Hill update: PBMs, 340B, animal drugs, and more |
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Market distortions caused by pharmacy benefit managers (PBMs) were criticized in two House hearings yesterday as legislation related to PBM transparency and the 340B program moved forward. What happened: The Energy & Commerce Health Subcommittee advanced 17 bills with bipartisan support to a full committee vote, including legislation addressing transparency of PBMs and the 340B program, and Animal Drug User Fee Amendments. A House Ways & Means Health Subcommittee hearing also addressed PBMs.
“It’s a racket,” Subcommittee Ranking Member Anna Eshoo (D-CA) said of PBMs. “There is no merit to this … not any value added.”
The PBM bills:H.R. 2679, the PBM Accountability Act, combining earlier legislation to enable oversight of PBMs, and H.R. 1613, tackling “spread pricing” by PBMs.
The 340B bill:H.R. 3290, which would require hospital transparency of the 340B program—intended to help underserved communities but often abused by hospitals to get discounts from drug makers.
The Animal Drug User Fee bill:H.R. 1418, which would reauthorize animal drug user fee programs. The package was generally clean with two riders—antibiotic stewardship and defining large animals.
What’s next: The legislation approved yesterday goes to the full E&C Committee, where approval is likely, before a full House vote. Read in-depth coverage of the E&C markup on Bio.News. PBMs in the hot seat: Ways & Means Health Subcommittee Chair Vern Buchanan (R-FL), Ranking Member Lloyd Doggett (D-TX), and Reps. Glen Mulready (R-OK), Brian Higgins (D-NY), Stephanie Murphy (D-FL), Brian Fitzpatrick (R-PA). and Brad Schnieder (D-IL) all mentioned PBMs in their opening statements. What about price controls? The Inflation Reduction Act (IRA) is already stifling innovation, with at least 50 drugs pulled from development—even though PBMs are the real problem, said Rep. Murphy. |
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ARPA-H opens request for information on FDA collaboration and public-private partnerships
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ARPA-H is seeking unique and creative ideas on how to best collaborate with the Food and Drug Administration (FDA) to encourage and incentivize public-private partnerships in the health ecosystem, to accelerate better health outcomes for everyone.
This Request for Information seeks novel insights, ideas, incentives, approaches, and models at the development stage and during pre-submission, submission, and post-submission interactions to help promote and accelerate innovation to yield better health outcomes while prioritizing patient safety.
This effort aims to identify and understand innovative strategies that are possible under the current regulatory and statutory paradigm. The purpose is NOT to propose any changes to FDA regulatory authority or statutes. Respondents shall propose specific practices that the U.S. government might adopt to speed approvals and support emerging health innovations.
For more information on how to submit comments, visit here. |
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It's Global Accessibility Awareness Day – here's how to take action |
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Today is Global Accessibility Awareness Day (GAAD), which highlights the importance of accessibility and provides a chance to focus on how tech equity can lead to patient access. Bio.News spoke to experts about why it matters and how allies can take action.
Why it matters: GAAD is “a reminder to redouble our efforts,” Erika Smith, MBA, CEO of ReNetX Bio, Inc. and BIO Board Member and Emerging Companies Section (ECS) Vice Chair, told Bio.News.
What they’re doing: “ReNetX is working to advance critically important research and development that will lead to better patient outcomes, and for patients facing spinal cord injury, every day must be a Global Accessibility Awareness Day,” continued Smith.
How tech is improving patient access: Vincenzo Piscopo, President and CEO of the United Spinal Association, explained that wheelchair-using members are able to participate in online research studies with pharma partners and rehabilitation institutes thanks to technology.
“Many can only be included because of digital accessibility,” he said, thanks to tech like voice recognition software, headsets, and specialized keyboards and mice. United Spinal’s Tech Access Initiative works to remove barriers to tech.
Lessons from COVID: “Thanks to the adoption of technological solutions, employers were able to tap into our talented community members, no matter where they lived, and our employment rate rose quickly,” said Piscopo. Continuing virtual meetings, for example, can ensure both access to employment and participation in medical research.
BIO’s commitment to supporting innovation and championing the voices of patient advocates is stronger than ever, says Michele Oshman, BIO’s Vice President for External Affairs. “It is an incredible honor to lead BIO’s engagement with the patient advocacy community, and anytime we are able to work together to advance our shared mission, it truly is a win-win.” Read more on Bio.News about GAAD and how allies can be better advocates.
More Health News: The Wall Street Journal: FTC’s Amgen activism will spare smaller biotechs
“The Federal Trade Commission’s effort to block Amgen’s acquisition of Horizon Therapeutics is putting a damper on [the recent biotech stock] rally. The SPDR S&P Biotech exchange-traded fund was down 3.4% on Tuesday morning, with Horizon plunging 18%. Seagen, which agreed to sell itself to Pfizer for $43 billion in March, was down 6%.” |
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