The U.S. market's high prices create the large profit pool necessary to fund risky drug development. If the U.S. adopted price negotiation like other countries, the global incentive for pharmaceutical innovation would shrink, resulting in fewer new drugs being developed worldwide.

The SBIR/STTR programs, a vital source of non-dilutive funding for early-stage biotechs, remain on pause with no clear path to reauthorization. The logjam is due to a niche debate between a few members of Congress over foreign-funded company eligibility, stalling the entire program.

The FDA's new pathway for rare disease drugs, based on causal biology, is scientifically promising. However, the name "plausible mechanism" is a critical flaw. The term sounds weak, creating doubt for patients and giving payers powerful leverage to deny coverage by implying a lower standard of evidence.

The market is currently ignoring the long-term impact of deep cuts to research funding at agencies like the NIH. While effects aren't immediate, this erosion of foundational academic science—the "proving ground" for new discoveries—poses a significant downstream risk to the entire biotech and pharma innovation pipeline.

An ideologically driven and inconsistent FDA is eroding investor confidence, turning the U.S. into a difficult environment for investment in complex biologics like gene therapies and vaccines, potentially pushing innovation to other countries.

The Orphan Drug Act successfully incentivized R&D for rare diseases. A similar policy framework is needed for common, age-related diseases. Despite their massive potential markets, these indications suffer from extremely high failure rates and costs. A new incentive structure could de-risk development and align commercial goals with the enormous societal need for longevity.

Renowned gene therapy pioneer Jim Wilson was forced to spin out ultra-rare disease programs into a new company after his initial venture failed to attract VC funding. This demonstrates that even elite scientific leadership cannot overcome investor disinterest in this segment without powerful, predictable government incentives like transferable priority review vouchers.

The biotech ecosystem is a continuous conveyor belt from seed funding to IPO, culminating in acquisition by large biopharma. The recent industry-wide stall wasn't a failure of science, but a halt in M&A activity that backed up the entire system.

M&A is often framed as a win, but it can be detrimental to patients. The acquisition of an aggressive, fast-moving biotech by a large pharma company can lead to slowed development timelines and more conservative regulatory strategies, ultimately delaying access to life-saving treatments.