Inflation Reduction Act Defect Harms My Son
TL/DR –
The author criticizes the Inflation Reduction Act (IRA) for undermining the development of new therapies for psychiatric conditions such as schizophrenia by treating small and large molecule drugs unequally. The IRA protects new large molecule drugs for 13 years, but small molecule drugs, used in nearly all psychiatric medicines, for only nine, thereby forcing many biotech investors to stop funding psychiatric drug research and development. To correct this, the author recommends the enactment of the EPIC Act, which proposes to provide small molecule drugs with the same 13-year protection as biologics.
Concerns Over the Impact of the Inflation Reduction Act on Schizophrenia Treatments
Caring for a child suffering from schizophrenia involves many challenges. The psychiatric symptoms of this disease can prevent the person from leading a normal life. Medications can alleviate the worst symptoms, and potential new drugs are on the horizon that could provide unprecedented relief. However, these promising medicines may never come to fruition due to a provision in the Inflation Reduction Act (IRA).
The IRA legislation poses a threat to the development of new therapies for psychiatric conditions like schizophrenia. This is due to its regulation of medicines that come in pill form. If this error is not corrected by Congress, it could undermine the development of new treatments that could significantly improve patients’ lives.
Most orally administered medicines are chemically synthesized small molecule drugs. By contrast, medicines administered via infusion or IV are usually large molecule medicines or “biologics.” The IRA allows Medicare to negotiate prices for certain branded prescription drugs, but it does not treat small and large molecule drugs equally. It protects new large molecule medicines for 13 years, while small molecule drugs are safeguarded for only nine.
This inequality poses a threat to people with psychiatric conditions like schizophrenia and bipolar disorder, given that almost all psychiatric medicines are small molecules. These drugs can penetrate the blood-brain barrier to treat the neurological underpinnings of these disorders. The discrepancy could deter biotech investors from funding psychiatric drug research and development.
A recent survey showed over 80% of bioscience firms researching mental illness expect the law to hinder their R&D, with more than 60% planning to shift away from the small molecule category. The high cost of developing new drugs, averaging $2.6 billion, means manufacturers need to recoup these investments to stay in business.
The same survey indicated that 95% of firms expect to develop fewer new uses for existing drugs, a process that often brings promising psychiatric medicines to new patient populations.
The IRA’s unequal treatment of small molecules can significantly impact the future of pharmaceutical development. A study from the University of Chicago found that the law’s distorted incentive structure will result in 79 fewer small molecule drugs coming to market over the next 20 years.
The IRA risks creating a system that further marginalizes psychiatric patients, who already face stigma, affordability challenges, and other barriers to care. The costs of psychiatric diseases are enormous, comparable to many physical ailments. For instance, Schizophrenia alone reduces average life expectancy by around 15 years and costs the US over $280 billion annually, according to the National Schizophrenia & Psychosis Action Alliance.
It’s not too late for Congress to rectify this mistake. North Carolina Reps. Don Davis and Greg Murphy have introduced the bipartisan EPIC Act. This act will offer small molecule drugs the same 13-year protection extended to biologics. This minor change could help millions of patients living with serious psychiatric conditions access medicines that will enable them to lead more fulfilling lives.
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