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BIO opposes GLOBE Model's use of MFN pricing. BIO on the American Road visits North Carolina. (957 words, 3 minutes, 49 seconds) |
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BIO says GLOBE Model threatens innovation ecosystem |
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BIO criticized the newly released GLOBE Model designed to impose Most Favored Nation (MFN) price controls on some drugs under Medicare Part B.
What it is: The GLOBE Model pilot project tests “an alternative method for calculating Medicare Part B drug inflation rebate amounts for certain separately payable Medicare Part B drugs and biological products,” according to the Centers for Medicare and Medicaid Services. It uses “international drug pricing information to identify a benchmark that reflects prices paid in a set of economically comparable countries.”
Why it won’t work: “Mandatory, government price-setting policies under the guise of ‘most-favored nation’ will not address the underlying drivers of health care costs, nor will they remove the barriers that keep patients from accessing the medicines they need,” says a statement from BIO. “Instead, the decision to finalize the GLOBE model threatens the innovation ecosystem that makes new treatments and cures possible.”
The risk: “At a time when the United States should be strengthening its leadership in biotechnology, MFN only further enables the ascent of China, which is aggressively investing in life sciences and advanced technologies,” BIO says.
Read more about MFN from BIO: Simplify the System.
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BIO on the American Road visits NC’s famous Research Triangle Park |
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North Carolina, already a leading location for biotech manufacturing, is experiencing a boom this year, a BIO on the American Road tour delegation learned.
The mission: BIO President and CEO John F. Crowley led the latest in BIO’s visits to biotech ecosystems, an Oct. 2 trip to the famous life-sciences cluster of Research Triangle Park (RTP). BIO toured Biogen’s facility and met with House Judiciary Committee member and biotech IP champion Rep. Deborah Ross (D-NC) and patient advocates.
BIO member Biogen, already the largest biotech employer in North Carolina, is creating more jobs with its $2 billion investment, announced last year. “Given recent acquisitions, we are also evaluating additional potential investment opportunities based on our late-stage portfolio,” said Nicole Murphy, Biogen EVP.
Others expanding manufacturing in NC:
A pro-biotech state: BIO visited the NC Biotechnology Center, the first state-sponsored initiative of its kind to support the biotech industry. With more than 100,000 biotech workers in North Carolina, federal and state legislators in NC are pro-biotech, per Laura Gunter, President of NCLifeSci, BIO’s affiliate in the state.
What they're saying: “It’s more important than ever that we develop new medications here at home that are accessible and affordable,” Rep. Ross said.
BIO's view: "The U.S. must continue to lead in biotechnology, and that requires building a stronger American biotech industry," Crowley said. "North Carolina and RTP are demonstrating the power of bringing innovation, investment and manufacturing together.”
Read more on Bio.News.
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Tariffs’ drag on innovation compounded by lack of guidance. Continuing lack of guidance is exacerbating the harms that tariffs on patented pharmaceuticals and their ingredients cause for the biotech industry, especially the small firms driving innovation, experts say. Tariffs of up to 100% on patented pharmaceuticals that went into effect Sept. 29, are expected to increase costs for innovators, discourage drug development and investment, and potentially reduce patient access to drugs they need. They also weaken U.S. competitiveness at a time when China is seeking to replace America as the world leader in biotech, experts say. Read more on Bio.News.
Bayer announces $2.2B investment in Ohio manufacturing site. BIO member Bayer on Oct. 2 announced plans to invest $2.2 billion in a new pharmaceutical manufacturing site in New Albany, Ohio, building on more than $7 billion in U.S. pharma R&D and manufacturing spending over the past five years. Bayer says it expects to create around 600 high-value jobs in the New Albany International Business Park and about 1,500 construction jobs during construction. “Bayer has long seen the United States as a key manufacturing base and innovation hub. This landmark investment underscores our commitment,” said Bayer CEO Bill Anderson. Read more here. |
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The Senate Judiciary Subcommittee on Intellectual Property held a Sept. 28 hearing on Oversight of the United States Patent and Trademark Office (USPTO), with U.S. Patent and Trade Director John Squires as the sole witness.
- Ranking Member Adam Schiff (D-CA) said: “Our intellectual property system is the engine of the American economy. It provides critical incentives for groundbreaking research, protects our creative industries, and supports millions of high-paying jobs across California and the nation. At its core, a system relies on the delicate balance, granting robust, reliable IP rights that reward innovation while ensuring the public and independent inventors retain the freedom to compete, collaborate, and build upon existing ideas.”
- Sen. Katie Britt (R-AL) asked about a solution for AI generating spurious patent challenges, saying: “One of my concerns, though, is how AI can be used by filers to undermine the patent system, particularly when it comes to biopharmaceutical innovation, that entire space. I worry about generative AI actually being used, foreign adversaries potentially mass-producing filings at very little cost.”
- Subcommittee Chair Thom Tillis (R-NC), who is retiring and chaired his final hearing, discussed his proposed Patent Eligibility Restoration Act (PERA), which would clarify what makes ideas eligible for patents and is supported by BIO: “PERA restores eligibility for important inventions in fields such as medical diagnostics, biotechnology, personalized medicine, artificial intelligence, 5G, and blockchain. It will help ensure that the United States remains the world's innovation leader.”
Both the House and Senate are back home campaigning through the election. They will return the week of November 9.
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