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The Ensuring Pathways to Innovative Cures (EPIC) Act would align price negotiation timelines for small molecules and biologics, giving each category 13 years of post-approval protection. As millions of veterans struggle with mental health or behavioral conditions, we need to protect their access to innovative therapies. That starts with passing the EPIC Act.

The Ensuring Pathways to Innovative Cures (EPIC) Act would align price negotiation timelines for small molecules and biologics, giving each category 13 years of post-approval protection. As millions of veterans struggle with mental health or behavioral conditions, we need to protect their access to innovative therapies. That starts with passing the EPIC Act. (Pixaby)

As a nation, we have a sacred duty to support the men and women who put their lives on the line to defend our freedoms. That responsibility doesn’t end when their service does. Once military members return home, we must ensure they have the health care they need to live their best lives — including treatments for mental health conditions.

Bipartisan majorities in Congress have made a priority of this issue, notably with their overwhelming support for the Commander John Scott Hannon Veterans Mental Health Care Improvement Act of 2019. Current VA Secretary Denis McDonough has been steadfastly committed to the Hannon Act’s implementation — demonstrating continuity through administrations of both parties. Bipartisan legislation addressing causes of veteran suicides, meanwhile, has been gaining momentum.

Unfortunately, though, a single provision in the 2022 Inflation Reduction Act threatens to undermine this progress. The law is inadvertently discouraging the development of next-generation psychiatric medications that could benefit countless veterans. The good news is that an easy, bipartisan fix is now in the works.

Mental health challenges remain heartbreakingly common among our nation’s heroes. Rates of post-traumatic stress disorder are higher among veterans than civilians. Gulf War veterans are twice as likely to suffer from depression as the general population. One study found the suicide rate among veterans is 1.5 times higher. Sadly, it is estimated that 17 veterans die by suicide every day, and over half of veterans living with mental illness aren’t receiving treatment.

These painful statistics reflect the unique stresses and traumas of military life. Combat exposure, family separation, reintegration into civilian life — each can take a heavy psychological toll. Along with this higher risk burden, social stigma around mental illness and access challenges frequently prevent veterans from getting the care they need.

Drug researchers have responded to mental illness with an expanding arsenal of treatment options. The United States is currently responsible for about half of all new medications developed worldwide.

But affordability is also an important issue. To address it, the IRA gave Medicare the authority to negotiate with drug makers for lower prices. To help ensure pharmaceutical developers have time to recoup their investment costs, lawmakers wisely granted newly approved medicines a period of exemption from price negotiations.

But oddly, this exemption period isn’t the same for all drug types. Under the law, new “large molecule” biologic medicines are exempt from government price negotiations for 13 years after FDA approval, whereas small-molecule drugs receive only nine years of exemption.

Typically, years 10-13 following FDA approval account for revenues equal to those generated in years one through nine. This means that the IRA’s nine-year exemption period for small molecules simply isn’t enough time for most firms to earn back their research and development costs, which can top $2 billion per new drug approval.

Unsurprisingly, this disparity is already leading drug companies to deprioritize or abandon small-molecule treatments. In a recent survey of over two dozen prominent biopharmaceutical firms, 63% said they plan to shift investment away from small molecules because of the IRA. Every shelved R&D project represents a potential breakthrough that will never reach patients.

This alarming trend could have serious consequences for veterans seeking treatment options for mental illness. Small molecules have a key advantage when it comes to treating mental health conditions: they’re tiny enough to cross the blood-brain barrier. That’s why small molecules make up virtually all psychiatric medications, from antipsychotics to antidepressants. And it’s why many of the most promising new mental health drugs — for conditions like treatment-resistant depression, PTSD, addiction and anxiety —predominantly belong to this category.

The IRA’s bias against small molecules will also worsen existing inequities in care access. Small-molecule medications usually come as easy-to-use pills, while biologics typically require injections or IVs administered by a health care professional. Treatment via biologics imposes an additional burden on rural and low-income veterans who don’t live near medical facilities.

I believe policymakers who crafted the IRA were genuinely trying to help patients, not introduce new barriers to treatment. But when confronted with the reality of these unintended consequences on patient access to small-molecule medicines, they have a responsibility to take corrective action.

Thankfully, a straightforward, bipartisan fix has already emerged. The Ensuring Pathways to Innovative Cures (EPIC) Act would align price negotiation timelines for small molecules and biologics, giving each category 13 years of post-approval protection.

As millions of veterans struggle with mental health or behavioral conditions, we need to protect their access to innovative therapies. That starts with passing the EPIC Act.

Anthony J. Principi served as secretary of Veterans Affairs from 2001-2005.

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