When most Americans think of cutting-edge medicine, they envision lifesaving breakthroughs, like targeted cancer therapies and precision drugs for rare diseases. But few people realize how policy choices in Washington, D.C., can directly shape the future of these breakthroughs.
One such policy challenge is the emerging imbalance in investment between large-molecule biologics and small-molecule drugs — the latter often formulated as pills. The Ensuring Pathways to Innovative Cures (EPIC) Act is a timely and essential piece of legislation that would help correct this imbalance and ensure patients don’t lose access to the convenient, affordable treatments they rely on.
Small-molecule drugs, typically administered as pills or capsules, are a cornerstone of modern medicine. From cholesterol-lowering statins to game-changing antivirals like those used to treat HIV or hepatitis C, these oral medications have transformed life expectancy and patient quality of life. They are easier to store, prescribe, and take — especially for patients managing multiple chronic conditions.
But recent changes in federal drug pricing policy, have inadvertently created a chilling effect on small-molecule drug development. Under current rules, small-molecule drugs are eligible for price negotiations just nine years after FDA approval, while large-molecule biologics are shielded from price negotiations for 13 years. That four-year difference may sound minor — but in the high-stakes world of pharmaceutical innovation, it has outsized consequences.
Drug development is a long, risky and expensive process. Investors and companies must decide where to place their bets. A four-year difference in price negotiation can easily tilt the scales in favor of large-molecule biologic development rather than maintaining the investment balance American patients have benefited from for years. The result? A potential future where convenient, oral drugs are deprioritized in favor of more complex, biologics which tend to be administered in clinical settings as infusions. That’s bad news for patients, especially older Americans or those with limited access to infusion centers.
The Ensuring Pathways to Innovative Cures Act aims to restore balance by giving small-molecule drugs the same 13-year negotiation timeline as their biologic counterparts. It’s a modest fix with a major upside: preserving a robust pipeline of pill-based treatments that are often cheaper to produce, easier to distribute and simpler for patients to use.
Rep. Brad Schneider, a Highland Park Democrat, has been a leader on health care innovation and his district is home to a number of pharmaceutical manufacturing facilities. He should join his colleagues in Congress in supporting the EPIC Act to send a clear message: we support innovation in all forms, and we believe patients should continue to have access to transformative treatments in the form they can actually use.
For the sake of continued medical progress — and for every patient who’d rather take a pill than drive to an infusion clinic — lawmakers should pass the EPIC Act.
• Mark Denzler is president & CEO of the Illinois Manufacturers’ Association.