|
|
|
A busy week on Capitol Hill brought promising developments on orphan drugs, PBM reform, tax deductions for R&D, and sustainable aviation fuels. (688 words, 3 minutes, 26 seconds) |
|
|
|
|
Progress on PBM reform, ORPHAN Cures as reconciliation bill advances |
|
|
The GOP reconciliation bill advanced by the House Budget Committee last night includes legislation to encourage rare disease drug development, check middlemen who inflate drug prices, and enable tax deductions for research.
Key BIO priorities: In a marathon mark-up, the House Energy and Commerce Committee approved health provisions supported by BIO as part of a reconciliation bill on federal spending. These include: - Language from the ORPHAN Cures Act to fix the Inflation Reduction Act’s disincentives for orphan drug research.
- PBM reform measures ending Medicaid spread pricing, de-linking PBM compensation from Part D prices, and adding transparency to PBM operations to keep them from driving up drug prices. (PBMs were also the subject of a May 13 Senate Judiciary hearing.)
- The Accelerating Kids’ Access to Care Act to help children with rare diseases get specialized care in other states.
MFN concerns: Committee Chair Brett Guthrie (R-KY) questioned the Executive Order on Most Favored Nation drug price controls, saying America needs to fund research. Rep. Richard Hudson (R-NC) agreed, noting government price controls won’t make drugs more affordable.
R&D tax deductions:The House Ways & Means Committee approved a tax package for the reconciliation bill that includes reinstatement of the 100% tax deduction for R&D.
What's next: The bill must receive House Rules Committee approval before it can go to the full House. If passed by the House, it goes to the Senate.
Read more in Bio.News.
|
|
|
|
|
SAF Coalition commends plan to extend tax credits |
|
|
Provisions in the reconciliation bill that would extend tax credits for producing Sustainable Aviation Fuel (SAF) were commended by the SAF Coalition (which includes BIO).
What are SAFs? Made with biotech from renewable feedstocks, SAFs can be dropped into existing commercial airline engines to reduce carbon emissions by 70% compared to fossil fuels.
The legislation: The House Ways & Means Committee segment of the reconciliation bill on taxes would continue the Inflation Reduction Act’s 45Z tax credit for producing low-emission fuels until 2031 — including credits ranging from 35 cents to $1.75 per gallon for producing SAFs.
Why it matters: “SAF is a key solution for strengthening U.S. energy dominance, driving investment in rural economies and positioning the United States as a global leader in SAF production,” says an announcement from the coalition. |
|
|
|
What Else to Read This Week |
|
|
The Inflation Reduction Act has reduced secondary orphan drug designations. The provisions limiting exemptions for orphan drugs that treat a single rare disease have reduced efforts to expand the benefits of these drugs, finds a new report by the National Pharmaceutical Council. “Following the passage of the IRA, the percentage of drugs with a first orphan designation that later received a second designation decreased by 48.0% (12.1% pre-IRA to 6.3% post-IRA),” says the brief.
Personalized gene therapy credited with saving a baby’s life offers promise of cures for rare diseases. The CRISPR-based treatment could be replicated and repurposed to treat all kinds of genetic defects that cause rare disease, researchers said. The result “is a triumph for the American peoples’ investment in biomedical research,” Dr. Fyodor Urnov said. The researchers emphasized the role government funding played in the development. Read more.
FDA gives Novavax COVID-19 vaccine full approval. The Food and Drug Administration (FDA) on Friday announced approval of Novavax’s COVID-19 vaccine for adults 65 and older—and those 12 to 64 who have at least one health problem that puts them at increased risk from COVID-19. Novavax’s protein-based vaccine is the only non-mRNA COVID-19 vaccine with FDA approval. It had already received FDA emergency use authorization for anyone 12 and older in 2022. Novavax chief executive John C. Jacobs welcomed the licensure. “Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option,” he said, according to the Associated Press.
FDA vaccine advisors to meet Thursday for discussion of COVID vaccine composition.The Food and Drug Administration (FDA) announced its Vaccines and Related Biologics Advisory Committee (VRBPAC) will meet Thursday in an open session to discuss recommendations on the composition of the 2025-26 COVID-19 vaccines. Vaccine makers require a few months to formulate their vaccines according to the recommended composition and get the products cleared for the next respiratory virus season. Read more.
Sanofi announces at least $20 billion in investments in R&D and manufacturing in the U.S. through 2030. The investments will create high-paying jobs in several states, the company said. “Sanofi's 13,000 U.S.-based employees are pioneering the research and development of first- and best-in-class medicines across numerous therapeutic areas. Our expected investments in the U.S. will be substantial and will help ensure the production of key medicines in the U.S., " said Sanofi CEO Paul Hudson.
Biotech industry leaders join BIO on Capitol Hill to underscore biodefense as national security imperative. More than 20 executives from leading biotechnology and biodefense companies joined BIO on Capitol Hill May 14 to meet with Congressional offices engaged in protecting the civilian and the warfighter. The fly-in was a reminder that biotechnology innovation is central to America’s biodefense and national security infrastructure. Industry leaders called on Congress to continue prioritizing strategic investments in medical countermeasures in agencies such as ASPR, BARDA, and the Department of Defense, to maintain America’s readiness in biodefense. The fly-in comes on the heels of a major report from the National Security Commission on Emerging Biotechnology (NSCEB), which warns that biotechnology will define future domains of geopolitical competition. BIO had a clear call to action: Congress must ensure that biodefense remains a core national security priority, not just in moments of crisis, but during peacetime as well. |
|
|
|
|
|
|
|
|
|
