Spokane is just beginning to realize its potential as a regional hub of life science industry innovation, particularly emphasizing new therapeutic discoveries to combat complex neurological illnesses like Amyotrophic Lateral Sclerosis, commonly known as ALS.
Foundational research happening locally is just the first step down a long road that any new drug must take on the pathway to approval by the Food and Drug Administration before ending up in a patient’s medicine cabinet. New medicines typically take 10 to 15 years to traverse bench science and clinical trials, before receiving FDA approval. The discovery and development process costs billions in private capital and carries a 90% failure rate.
As the government soon will begin implementing new Medicare cost-cutting policies in the Inflation Reduction Act, lawmakers must proactively preserve the public and private investment ecosystem that allows our country to lead the international community in new therapeutic discovery.
U.S. innovators are responsible for four in 10 new medicines that are developed across the world.
Many diseases that were once considered a death sentence now can be cured outright or managed as chronic conditions. American-made therapeutics lead the fight against cancer, HIV/AIDS, cardiovascular disease, and many other life-threatening illnesses. You can see the impact in comparative mortality outcomes. As one example, the U.S. five-year survival rates for cancer outpace similarly developed nations.
Our innovation ecosystem works on the premise that the federal government provides reasonable patent protections and assurances of consumer safety to make newly approved medicines broadly available to patients through programs like Medicare. For scientists, the inherent risk of the drug development process is offset by the opportunity for U.S. market access.
Until recently, Medicare would guarantee a fair reimbursement rate for prescriptions to account for the decade-plus of investment necessary to discover them in the first place. The Inflation Reduction Act changes that calculation for the drug development pipeline in ways that could compromise the future of new therapeutic discovery in the U.S.
Just last week, the Centers for Medicare & Medicaid Services released a list of medicines that would be subject to price controls by the federal government starting in 2026. Congress also legislated disparate timelines for price-setting policies to impact future drugs still under development. Capsules, pills, and tablets, known as small-molecule medicines, could be subject to price controls nine years after receiving a patent, while clinically administered large-molecule infusion medication could be subject to price controls 13 years after receiving a patent.
The chilling effect on drug development by the Inflation Reduction Act has been immediate and disheartening.
Large and small life science companies have announced reducing or eliminating whole research lines. Rare disease therapeutics that hold promise for conditions that impact smaller patient populations, like ALS, have been paused.
At the same time, scientists try to recalculate for lost public investment more than a decade into the future. Life science companies are second-guessing which drug development pathways might put them underwater on costs in 10 or 15 years instead of staying focused on how to expedite new cures to patients in need.
These changes could have a chilling effect on therapeutic startup companies, since less than 50% of the preclinical pipeline is owned by traditional pharmaceutical companies. Every shelved therapy represents a community of people who won’t get access to the medical intervention they’ve been waiting for.
Congress still has time to chart a path forward that strikes the right balance between reducing Medicare spending and ensuring the U.S. life science innovation sector continues to thrive.
To create a more predictable environment that supports lengthy and expensive drug development processes, lawmakers could level the playing field on patent protections between small-molecule and large-molecule medicines. The nine-year versus 13-year distinction makes no functional sense; it just means less investment will flow to research for medications that will ultimately be available in pill form. These medicines are less expensive for patients and are the only drugs to date that can cross the blood-brain barrier.
Penalizing small-molecule drug development will systematically undermine research for neurological illnesses and undercut some of the most promising work on the next frontier of cancer drug development. New therapeutic targets emerging in cardiovascular and chronic kidney disease management may go unexplored.
A flat, 13-year post-patent timeline for price controls to affect both large and small-molecule medications is a more reasonable balance to support continued innovation and life science discovery.
Katrina Rogers is the CEO of Spokane-based Evergreen Bioscience Association, an industry-led organization working to make Washington state a magnet for life and health science companies.