Serious Defect in The Inflation Reduction Act Will Hurt My Son

 As the parent of a child who suffers from schizophrenia, I've slowly become acclimated to the necessary -- and extremely difficult -- task of caring for someone whose psychiatric symptoms prevent him from living a fully normal life.

I wouldn't be able to do it without medications that alleviate my son's worst symptoms. I'm hopeful that potential new drugs on the horizon could provide him -- and countless other patients -- with unprecedented relief from this devastating disease.

But I'm also worried that those medicines, though scientifically promising, may never actually come to fruition -- all because of a provision buried in the Inflation Reduction Act (IRA).

That legislation contains a fatal flaw in how it regulates classes of medicines that come in pill form. If Congress fails to fix this error, it could significantly undermine the development of new therapies for psychiatric conditions like schizophrenia -- robbing people like my son of future treatments that could dramatically improve their lives.

Most medicines that can be taken orally, in pill or tablet form, are chemically synthesized small molecule drugs. By contrast, most medicines that are administered by infusion or IV are grown from living cell cultures and called large molecule medicines or "biologics."

While the IRA allows Medicare to negotiate prices for certain brand-name prescription drugs, it wisely exempts newly approved medicines from price setting for a time -- which protects incentives for research and development. But it doesn't treat small and large molecule drugs equally. The IRA protects new large molecule medicines for 13 years, but small molecule drugs for only nine.

That disparity seriously imperils people with psychiatric diseases such as schizophrenia and bipolar disorder. Almost all psychiatric medicines are small molecules, since these drugs can readily penetrate the blood-brain barrier to treat those disorders' neurological underpinnings. By providing these therapies with four fewer years of protection from government price setting than biologics, the IRA could force many biotech investors to cease funding psychiatric drug research and development.

In fact, a recent survey found that over 80% of bioscience firms currently researching mental illness expect the law to hinder their R&D, and more than 60% report planning to shift away from the small molecule category altogether. It's not hard to see why. Developing any new drug costs an average of $2.6 billion. Drug manufacturers need to recoup those enormous upfront investments to stay in business and fund the development of future therapies. Arbitrarily constraining biotech companies from generating a return on small molecules will inevitably lead them to bet on biologics instead.

The same survey also found that 95% of companies expected to develop fewer new uses of existing drugs, a process that often brings promising psychiatric medicines to new patient populations.

Ultimately, the IRA's disparate treatment of small molecules has major implications for the future of all pharmaceutical development. A study from the University of Chicago found that the law's distorted incentive structure will lead to 79 fewer small molecule drugs coming to market over the next two decades.

The IRA risks entrenching a two-tiered system that further marginalizes patients with psychiatric illness, many of whom already face stigma, affordability challenges, and other onerous barriers to care. Through my son, I've seen firsthand just how debilitating schizophrenia can be. It often prevents sufferers from holding a job, going to school, having friends, or even leaving the house.

The human and societal costs of psychiatric diseases are also enormous, and on par with many physical ailments. According to the National Schizophrenia & Psychosis Action Alliance, schizophrenia alone cuts average life expectancy by around 15 years and costs the United States more than $280 billion each year.  Those expenses largely stem from caregiver burden, homelessness, and incarceration, all of which are exacerbated when people with schizophrenia lack access to the best medicines available.

Fortunately, it's not too late for Congress to fix this dangerous mistake. In fact, North Carolina Reps. Don Davis and Greg Murphy -- a Democrat and Republican, respectively -- recently introduced the bipartisan EPIC Act, which would provide small molecule drugs with the same 13-year protection already afforded to biologics. This minor change would leave all of the IRA's existing benefits intact.

Honing the IRA to restore incentives for small-molecule drug development will help ensure that millions of patients living with serious psychiatric conditions -- including my son -- can access medicines that enable them to live more normal, fulfilling lives.

Sherri McGimsey, mother of a son living with schizophrenia

https://www.realclearhealth.com/blog/2024/03/21/a_serious_defect_in_the_inflation_reduction_act_will_hurt_my_son_1019701.html