A couple years ago, when the Inflation Reduction Act was passed, a major component of that bill was the ability for Health and Human Services to negotiate prescription drug prices. Leaving aside the question of how much of this is actually a “negotiation,” the legislation created a major problem that is quickly disrupting the drug pipeline. That policy is known as a “pill penalty”.
Under the pill penalty, small-molecule medicines are subject to “negotiations” after nine years from their FDA approval. The negotiation period for large-molecule medicines, more commonly referred to as biologics, begins after 13 years. Because small-molecule drugs are to be “negotiated” after only nine years, there is not enough time for a biotech firm to recoup the cost of research and development that comes with bringing a new drug to the market. The result has been a slow and steady decline in investment in these types of drugs. The next domino to fall after that will be a decline in new medications.
This is where we must define the differences between small-molecule medicines and biologics. Simply put, small-molecule drugs are typically drugs that come in pill form, like Advil or Tylenol. Biologics are typically drugs administered at a doctor’s office. Given that more than 90% of prescriptions in this country are small-molecule drugs, it’s easy to see what America’s preference is for treatment.
Speaking specifically about cancer, small-molecule drugs have made tremendous strides in treating certain types of cancers that were previously considered “undruggable”. Furthermore, the convenience they provide for patients means that those with cancer are more likely to complete their treatments.
As we continue to paint the bigger picture on the impact of fewer small-molecule drugs, we must look at the importance they play in our rural and underserved population. Arizona’s rural population is growing, according to the most recent U.S. Census. There are over 750,000 Arizonans who likely don’t have a wide range of choices when it comes to healthcare as much as their counterparts in urban areas like Phoenix or Tucson do. That means limited access to doctors, pharmacies, and emergency services. That is important because small-molecule drugs help bridge the infrastructure gap that occurs in rural care. They have a longer shelf-life, cost less thanks to the prevalence of generics, and can be self-administered (unlike biologics). A healthcare system that leans towards biologics and getting treatments at a doctor’s office or community health center is a step backwards.
Oftentimes in Congress, it takes several years or even decades to recognize a problem, but this one became so glaring after the IRA passed that officials quickly saw that action needed to be taken. The bipartisan Ensuring Pathways to Innovative Cures (EPIC) Act was recently re-introduced in Congress in the House of Representatives and we are hopeful the Senate will follow suit with companion legislation soon. The goal of the bill is simple: to fix this imbalance by extending small molecules medicines’ exclusivity to match the 13 years granted to biologics.
Arizona has always had pragmatic leaders in Congress who put solutions above party. It’s critical that we continue that tradition when it comes to protecting our country’s ability to create life-saving cures. Senators Mark Kelly and Ruben Gallego will have a tremendous opportunity to show Arizonans that they are willing to fix this “pill penalty” by supporting the bill and urging their colleagues to do the same. We cannot delay this any longer. The future of treating cancer is on the line.
Fred Taylor is the founder of Southwest Prostate Cancer Foundation
This article was originally published at www.thecentersquare.com
