Today, there are a multitude of prescription drugs that help patients suffering from mental illness lead fuller, happier and more productive lives. I am one of those of patients. I am a prescribed user of medication to treat depression and anxiety. Not only does this medication lift the dark clouds that can overwhelm my days, but it comes in pill form, making it much easier for me to adhere to my provider’s prescribed frequency of use and dosage. It’s well documented that medication compliance is a significant factor in achieving favorable patient outcomes. Moreover, most medications used to address a range of mental health conditions, from depression to schizophrenia, are taken orally.
Unfortunately, since passage of the Inflation Reduction Act (IRA) in 2022, it’s become clear that the IRA is detrimental to medications in pill form — what scientists call small molecule drugs. In fact, the IRA regulates drugs in pill form more harshly than other forms of treatment, such as infusions or IV therapies, what scientists call large molecule drugs or “biologics.”
Often referred to as the “pill penalty,” the IRA specifically allows Medicare to negotiate and set prices for small molecule drugs nine years after an initial FDA approval, compared with 13 years for biologics. There appears to be no scientific reason for this distinction between the two types of drugs. Innovation is already producing better treatments for mental illness, but hopes for even more effective medicines in the future will be dashed if this discrimination in the law isn’t fixed. Moreover, small molecule drugs frequently become generics, providing lower-cost options to patients, so putting pills at a disadvantage just doesn’t make sense.
Nine years is not enough time to recoup the expensive and risky investments into small molecule R&D before Medicare price controls kick in, especially when biologics are given four more years of reprieve. The uneven playing field will ultimately deter the discovery and development of oral medications, potentially leaving many important drug candidates on the shelf. Patients will bear the brunt of this chilling effect. In fact, a study from the University of Chicago, titled “The Impact of Price Setting at 9 Years on Small Molecule Innovation Under the Inflation Reduction Act,” found that the IRA’s disparate incentives will result in 79 fewer small molecule drugs coming to market over the next two decades.
There is a solution. Congress can enact the bipartisan Ensuring Pathways to Innovative Cures (EPIC) Act, recently introduced by Reps. Greg Murphy, MD, R-N.C., and Don Davis, D-N.C., and others, which would afford small molecule drugs the same 13-year exemption already provided to biologics. Medicare’s ability to negotiate and control drug prices would remain in place. Only now, the time to negotiation would be the same.
With a team of dedicated professionals, I founded Mental Healthy F.I.T. (Films, Ideas, Tips), a Utah nonprofit whose mission is to end mental health stigma through creative education, entertainment and impact. We help communities and individuals visualize turning points by bringing our shadows into the spotlight through talks, films, workshops and events.
Delivering a brighter future for mental health is a big job — spanning strategies from education to medication. In its current form, the IRA could further isolate those with mental health challenges by making it more difficult to do the research in small molecule drugs that would help me and countless others enhance our lives and pursue our dreams. Let’s advocate positive change and awareness in all aspects of mental health. That includes fixing the IRA.