Let’s Help Energize the Discovery of New Medicines
There’s been a lot of talk for the last few years about how the government’s rules, regulations, and legislation will, or already have, slowed the discovery of new medicines. I’ve written a lot about the Inflation Reduction Act (IRA) and how I believe the price-setting policies will limit innovation. As is always the case, both sides of the question wade in with their own evaluation of the impact of the IRA on innovation, with some saying there will be little impact. What is especially troubling is that whatever the effect turns out to be, there will be no way to remedy the problem quickly since the IRA’s ability to set the price of drugs is authorized for 10 years. What I can say for sure is that when companies or investors decide whether to invest a billion or two on a new drug with a one-in-ten chance of success, the fact that the government’s price fixing may limit their return on investment will have some effect on their decision.
Another way the government’s attempts to lower drug prices will affect innovation is by using the “march-in rights” portion of the Bayh-Dole Act to control the cost of new drugs. This part of the act enabled the government to shift the rights from a company that wasn’t developing the latest drug to another that would actively research and develop it. The government’s intervention in this process and fixing the price of a newly discovered drug will again chill the investors’ willingness to risk their money. According to both authors of this act, “march-in rights” was never meant to set drug prices. The threat of this unprecedented proposal has cast its shadow over the vitality of the National Institute of Health’s (NIH) research program. Once again, it seems a logical assumption that this will impact innovation. With the new administration’s plans to cut NIH’s budget, we can’t allow the march in rights of the Bayh-Dole Act to be misused to further inhibit innovation.
I’m sorry if I’ve painted a grim picture for all who harbor hopes for new medicines and cures, not just for us but probably more for our children and grandchildren. Sometimes, it seems we are powerless to affect what our government does to our healthcare, but there is something we can do right now.
We should all tell our lawmakers to support the proposed legislation that corrects some of the problems with the IRA, which is called the Ensuring Pathways to Innovative Cures (EPIC) Act. The IRA only allowed nine years for patent protection for small molecule medicines, which are almost always the pills that we take orally. This is opposed to the 13 years of protection granted for large molecule drugs, which are most often infused at a doctor’s office or hospital. This short patent protection time on the pills will discourage initial R&D investment and, maybe even more damaging; it will discourage the investment in ongoing research on approved small molecule drugs, which has often yielded expanded uses of the drug for other diseases. Research is discouraged because no additional patent period is granted to recover the costs of proving those new uses. This is especially hurtful for cancer drugs, where many drugs are approved for one type of cancer but are found to work on different types of cancers. Three out of five small-molecule cancer medicines were awarded at least one new indication after their initial approval. This unintended (or intended) consequence is often called the “pill penalty.”
The recent discovery that a drug initially approved for diabetes offers a breakthrough solution to obesity is one example of how important follow-up research is. The positive impact on the health of an overweight person losing 15 to 20% of their body weight cannot be overestimated, let alone the financial savings to our healthcare system.
If you step back and look at the IRA and how it punishes the small molecule drugs, you see that it really doesn’t make sense. Why would we discourage research in a type of medicine that is easy to take, has proven to be fertile ground for follow-on medicines, and improves access? The cost of a drug is not the only thing that inhibits access. If the large molecule-infused drugs are favored and are more prevalent, then more patients will need to pay for transportation or require caregivers to transport them to infusion facilities. This impacts rural and low-income patients the most.
The impact of this “pill penalty” is already being felt. The Eli Lilly CEO Dave Ricks said in the Hill newspaper, “In 10 years, we’ll have far fewer small molecules being developed than we do today.” His company has already halted efforts for a small-molecule blood cancer drug because it “couldn’t make the math work.”
Congress can go a long way toward making Americans healthier by simply ending the pill penalty and passing the EPIC Act. We need to raise our voices and get our lawmakers to fix this threat to innovation. The upcoming tax budget reconciliation bill may be a perfect vehicle for the EPIC Act, which has enjoyed the very rare label of bipartisan support. Contact your Senators and Representatives and tell them that future life-altering and lifesaving medications are important to you, your children, and your grandchildren, and they need to vote for the EPIC Act. Click here to see how to contact your lawmakers. Making your voice heard is one way you can have an impact on what our government does to our healthcare.
Best, Thair