May 14, 2024
Happy Tuesday! Long COVID may have slipped from the headlines, but a group of senators wants it to loom large in the coming appropriations process.
- And we have another report from our colleagues at Axios Pro Deals ā this time about how the deals world is thinking about the possible crackdown on China biotech.
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1 big thing: Senators mount new long COVID push
Illustration: Sarah Grillo/Axios
A group of Democratic senators backed by patient advocacy groups is pushing for over $1 billion in new spending for long COVID research in the next government funding package, Peter reports.
Why it matters: There are an estimated 17 million people in the U.S. who report having long COVID but still no FDA-approved treatments.
Driving the news: Sens. Ed Markey, Tim Kaine and Tammy Duckworth are calling for $1 billion for NIH and $200 million for ARPA-H for long COVID research.
- They are backed by patient groups like Long COVID Moonshot, who are trying to mobilize patients with long COVID to contact Congress in support of the request.
What they're saying: "Some long COVID patients are no longer able to participate in their family life, communities, schools and workplaces like they once did," Markey said in a statement.
Reality check: As the FY25 appropriations process gets underway, spending caps are creating a tough environment for major spending increases.
- "We are working with extremely tight funding caps that I have never supported ā but it is essential we continue to pursue breakthroughs to help patients struggling with long COVID," Senate Appropriations Chair Patty Murray said in a statement to Axios.
- Sen. Tammy Baldwin, chair of the health appropriations subcommittee, said she is "working closely with colleagues and stakeholders to support the NIH."
The big picture: Senate HELP Committee Chairman Bernie Sanders also last month released a draft bill to address long COVID that would provide $1 billion per year for 10 years in mandatory NIH funding and take steps to better coordinate research.
- It will be hard enough to pass a funding bump through the regular appropriations process, let alone enact a standalone stream of new mandatory funding, which tends to draw concern from debt-conscious Republicans.
- "In my view, the time is long overdue for Congress to treat long COVID as the public health emergency that it is," Sanders said in a statement at the time.
2. What the China biotech curbs means for deals
Illustration: Natalie Peeples/Axios
Our colleagues Erin Brodwin and Aaron Weitzman from Axios Pro: Health Tech Deals are back to tell you why the Biosecure Act ā due to be marked up by House Oversight on Wednesday ā is getting lots of attention among dealmakers.
Is this burst of activity chilling interest in biotech firms that contract with life sciences mainstays like WuXi App Tec or BGI?
- Short answer: "Definitely," executives and attorneys say.
- "There's a reputational risk associated with being partners in any capacity with any of those firms now," says Dave Latshaw, CEO of AI drug development BioPhy.
- The Biosecure Act could endanger companies' eligibility to be considered for federals contracts and grants ā "which are often the lifeblood of the industry," Latshaw adds.
- "There'll be more self-initiated serious investigations into these kinds of transactions," Foley & Lardner partner Christopher Swift predicts.
Should the government compensate firms that suffer losses from a ban the way it did with the CHIPS Act?
- Companies shouldn't hold their breath, with no legal precedence for such a move that's more reactive than proactive.
- Even if compensation were on the table, "You can pay back money but you can't pay back time," says Rob Tarbox, VP of marketing and product at Complete Genomics, one of the firms the bill would ban contracting with.
- Tarbox adds that a ban could significantly slow R&D for cell and gene therapies ā especially for those designed for rare diseases like Duchenne muscular dystrophy.
The Biden administration also is putting a focus on reviewing foreign investment deals that involve biotech. Appropriate or overreach?
- Dealmakers say the focus makes sense, given the sensitive patient data potentially at stake.
- "The transfer of U.S. information, about U.S. citizens, to Chinese parties, especially health care information ... that is a major concern," says Swift.
- "You've got to weigh two sides of the coin here. It's either, the foreign investment dollars that could enable research here in the U.S. on one side, or, the risk of, effectively IP leakage to foreign countries."
More drug giants are cutting deals with Chinese firms to develop and commercialize cancer drugs and other therapies. Do the out-licensing deals continue in this climate?
- Outlicensing will slow, dealmakers say.
- "If I had to think about the risk of a partner for commercial manufacturing or outlicensing IP, the latter might be riskier," Latshaw says.
- With a heightened focus on data security, "if human clinical trial data is involved in those deals, Uncle Sam is going to have an interest in knowing about it," Swift says.
3. Defense bill addresses TRICARE, mental health
Illustration: Sarah Grillo/Axios
The newly released House National Defense Authorization Act is devoid of some of the culture war provisions that plagued last year's bill but contains some notable language on TRICARE and mental health, Victoria reports.
Why it matters: The must-pass bill could yet become a magnet for controversial amendments on reproductive or transgender health, as well as the Biosecure Act or similar legislation addressing the reach of Chinese contract researchers in the U.S.
What's inside: The military personnel section of the bill has several measures aimed at improving quality of life for service members, which House Armed Services Committee Chairman Mike Rogers has said is the top priority of the FY25 NDAA.
- It would waive all fees and copays for the TRICARE dental program.
- Two pilot programs would be established allowing dependents of service members who become pregnant to switch their health care to TRICARE, while another would address postpartum mental health conditions in members and dependents.
- The bill asks for a report on medical issues affecting women during their military careers, such as menopause, in response to the increase in women serving in the armed forces.
- It also requests a status update on a Pentagon program to study the use of psychedelics to treat conditions like PTSD and traumatic brain injuries, to ensure the effort is "progressing without impediments."
What's next: House Armed Services is planning to mark-up the NDAA next week.
4. Catch me up: House suspenders, drug shortages
Illustration: Annelise Capossela/Axios
1. House health bills: The House is due to vote tonight on two health bills on the suspension calendar: a measure to support stillbirth prevention and research, and a bill to reauthorize the Emergency Medical Services for Children program through 2029.
2. Adderall shortage: House Oversight leaders are pressing the Drug Enforcement Administration on what it's doing about prolonged shortages of Schedule II drugs, including Adderall.
3. Private equity suit: A federal judge in Texas dismissed what could have been a landmark antitrust lawsuit against Welsh Carson Anderson & Stowe over anesthesiology services, Axios' Dan Primack reports.
4. Biden's dilemma: Public concern about health care costs threatens to overshadow President Biden's historic Affordable Care Act and Medicare accomplishments, Axios' Caitlin Owens writes.
ā Thank you for reading Axios Pro Policy, and thanks to editors Adriel Bettelheim and David Nather and senior copy editor Bryan McBournie. Do you know someone who needs this newsletter? Have them sign up here.
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