FDA Backs mRNA Tech, Calls for Private R&D Funding

FDA Confirms mRNA Support Amid Funding Shift

U.S. Food and Drug Administration Commissioner Marty Makary affirmed the agency's support for mRNA technology but stated that pharmaceutical companies, having earned over $50 billion, should now fund their own research and development without relying on U.S. taxpayer money. The statement clarifies the FDA's position following its decision to review a new Moderna flu vaccine.

Overview of the Policy Change

This position defends the U.S. Department of Health and Human Services' (HHS) recent decision to wind down federal funding for mRNA vaccine development. Commissioner Makary explained the move was not due to a lack of belief in the technology but a strategic pivot. Public funds are being reallocated to underfunded areas, such as developing gene therapies for rare diseases, which lack significant commercial investment.

Impact on the Pharmaceutical Sector

The policy shift places the financial responsibility for future mRNA research directly on major pharmaceutical firms like Moderna, Pfizer, and BioNTech. While Moderna previously used government funding for its COVID-19 vaccine, this new stance indicates that future projects, including promising mRNA-based cancer treatments developed with Merck, will require private capital. The FDA's continued approval of mRNA products, such as recent RSV vaccines from Moderna and GSK, signals that regulatory support remains strong despite the funding change.

Conclusion

Moving forward, the U.S. government will prioritize funding for less commercially viable but critical medical research. The pharmaceutical industry, particularly leaders in mRNA technology, must now internally finance their innovation pipelines. This change could influence corporate R&D budgets and future investment strategies for publicly traded biotech companies.

FAQ

Q: Why did the U.S. government cut mRNA vaccine funding?
A: According to the FDA Commissioner, the decision was financial. Companies that developed mRNA vaccines have earned over $50 billion and can now afford to fund their own research, freeing up taxpayer money for other medical priorities.

Q: Does the FDA still support mRNA vaccines?
A: Yes, the FDA continues to support mRNA technology and has approved several mRNA vaccines, including two for RSV. The policy change is about the source of research funding, not the agency's belief in the science or its regulatory stance.

Source: Investing.com