When then-Vice President Biden launched the Cancer Moonshot in 2016, there was reason to be optimistic. Decades of rigorous science had transformed many cancers from a death sentence to a manageable chronic disease. New treatment advances — including gene and cell therapies and immunotherapies — were showing stunning results. With support from the biopharmaceutical industry and the help of smart government policies, ending cancer was, and is, an achievable goal.
Unfortunately, while the president promised a war on cancer, he declared a war on the cure instead. As the head of PhRMA, an association representing America’s leading biopharmaceutical research companies, I work with my team to closely follow the policy debate and the impact on innovation. While they may have been well-intended, the Biden administration has adopted a series of policies that attack critical steps needed to bring new treatments out of the lab and to the patients who need them.
First, the administration eroded the foundation of scientific innovation by subverting intellectual property protections. In 2022, the White House caved to foreign competitors and global activists by agreeing at the World Trade Organization ministerial conference to waive IP protections that enabled the development of Covid-19 vaccines.
That caused the first tear in the IP fabric, signaling the United States would no longer vigorously defend the IP rights of researchers. Countries including China and India are now angling to waive IP protections for Covid-19 treatments, including those that could potentially treat cancer and other diseases. The administration has been unwilling to stop this global IP heist.
For life sciences companies, IP is the foundation. The certainty of knowing it will have exclusive rights for a limited time before copies hit the market is what enables companies to make long-term, risky investments into new medicines.
Next, the administration signed legislation giving them the authority to unilaterally determine the value of innovative medicines. Under the guise of “negotiation,” the Inflation Reduction Act (IRA) allows the federal government to set the price of medicines in Medicare.
Every time it has been tried around the world, government price setting reduces patient access to new cures and treatments. According to a recent report we released, patients in the U.S. have access to 85% of new medicines compared with 43% in France and 21% in Canada where governments set the price. Government price setting also leads to less innovation, and in the case of the IRA, cancer research will be especially hard-hit.
For example, the IRA’s price setting provisions disproportionately impact small-molecule medicines — medicines that typically come in pill or tablet form. These small but mighty treatments have a unique ability to target specific processes inside cells that allow tumors to grow and spread. The majority of cancer medicines approved for use today are small molecules.
Medicines typically face generic competition after they’ve been on the market 14 years. But the IRA cuts that time to nine years after FDA approval for small-molecule treatments. The consequences of this “pill penalty” are predictable. In a survey of our member companies, 63% who responded said they plan to shift focus away from small-molecule medicines.
The law’s price setting scheme also threatens research on existing treatments. Research companies often conduct clinical trials to learn whether an already-approved treatment can help more patients with a similar disease or those with different diseases entirely. It can take years to get results that show an approved treatment could benefit other patients.
Consider Xalkori. This targeted oral cancer therapy was first approved in 2011 for the treatment of an advanced non-small cell lung cancer caused by a specific gene abnormality. It would later receive six additional approvals across several patient populations, including one more than a decade after its initial approval.
This is how innovation works. A new analysis that the Partnership for Health Analytic Research prepared for PhRMA found that 61% of small-molecule cancer treatments approved between 2006 and 2012 received additional approvals for indications to treat other forms of cancers, with 41% occurring seven years or more after initial approval.
This post-approval research has been critical in the fight against cancer, as well as pediatric and rare diseases. But if it takes seven years to bring these treatments across the finish line and the government sets the price two years later, then it disincentivizes the clinical research needed to develop these new therapies.
As it writes rules to implement the IRA, the administration is making a bad law worse. Once a treatment is selected for government price setting, the administration intends to sweep in every new form that followed a medicine’s initial approval. This will subject to price controls new treatments that have been available for just a few years or even less.
Finally, the Biden administration is threatening the availability of medicines approved by the FDA through a program that has provided timely access to hundreds of treatments. Accelerated approval has sped the development of new medicines for patients where unmet need is greatest and no alternative or viable treatments exist, while adhering to the same standards for safety and effectiveness as traditional approval. It has been a resounding success since it was first developed during the HIV/AIDS crisis.
Fast forward to today, and the administration is supporting policies that would limit Medicare payment for medicines granted accelerated approval. Once again, those with cancer will be disproportionately harmed. Nearly 70% of medicines with accelerated approval have been in oncology. Companies will be forced to abandon the program if patients cannot access these treatments, and potentially lifesaving medicines will take longer to reach patients than they otherwise would.
The cumulative effect of these misguided decisions will be felt for years to come. They will undermine America’s global leadership and competitiveness. And they will harm our ability to develop new treatments for a whole host of diseases.
Advances in cancer research are not accidents, nor are they inevitable. They emerge from an ecosystem that encourages risk, discipline and drive — one we must preserve and protect. President Biden should end the assault on that ecosystem, and in doing so, help win the fight against cancer.
Steve Ubl is the president and CEO of PhRMA.