Colorectal cancer rates in children ages 10 to 14 have soared 500% in the past two decades, and are up 333% among teenagers, according to a recent analysis of data from the Centers for Disease Control.
Scientists are still trying to determine what’s causing this disturbing spike. But one thing is clear: Colorectal cancer is no longer just an older person’s disease. With more lives on the line than ever before, we must prioritize research into new treatments.
On the research front, there’s good news and bad news.
Scientists have made impressive progress in recent years. In 2023, the FDA approved a new therapy for patients with advanced-stage disease that doesn’t respond to other treatments. Cancer screening tests and surgical techniques have likewise improved. And collaborations have increased.
Unfortunately, many drug developers have started rethinking how they fund cancer research due to a little-known provision of the 2022 Inflation Reduction Act.
The IRA gave Medicare officials the ability to directly negotiate prices with drug makers. In order to give drug makers a chance to recoup their upfront research and development costs and earn a return, the IRA exempts new medicines from these price negotiations for a limited time.
Small-molecule drugs, which account for the majority of treatments for colorectal cancer and other cancers, receive a nine-year exemption. Large-molecule drugs, also known as biologics, receive 13 years of exemption.
The four-year discrepancy makes a big difference for investors and drug companies in deciding which potential treatments to fund.
Drug development isn’t fast, cheap, or guaranteed to succeed. All told, just 12% of drug candidates that enter clinical trials ultimately receive FDA approval. It can take an upfront investment of over $1 billion and a decade or more of work. Investors won’t fund such research unless they see a path to a return if their project succeeds. Pursuing biologic drug development, with its 13-year exemption, is a safer bet than small-molecule research projects, where any successfully developed drug would receive only nine years of protection.
The IRA also inadvertently discourages companies from researching new uses for already-developed drugs. The majority of cancer treatments originally developed to treat one form of the disease are subsequently approved to treat other forms, too. For example, the blockbuster drug Avastin was originally approved to treat colorectal cancer in 2004, but then later approved as a lung cancer treatment in 2006 and brain and kidney cancer treatment in 2009.
But to get a drug approved to treat multiple diseases requires additional clinical trials—an expensive proposition. If the exemption period is near or past expiration, companies are significantly less likely to fund trials for new indications. The math just doesn’t add up.
Fortunately, a bipartisan group in Congress is poised to correct this mistake. Their bill, the Ensuring Pathways to Innovative Cures Act (the “EPIC” Act), gives small-molecule drugs the same 13-year exemption biologics enjoy.
It’s a simple fix that would put cancer research back in the fast lane. With the current nine-year exclusivity period on the books, estimates suggest that 79 fewer new small-molecule drugs will come to market over the next two decades, and there will be 109 fewer subsequent approvals of existing drugs for new indications.
Small-molecule drugs are an essential tool in our fight against cancer. Oncology patients can’t afford to miss out on even one new therapy, much less over 100.
Lawmakers should act promptly. The lives of millions of current and future cancer patients are on the line.
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