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The new and now deadly measles outbreak in Texas is a reminder to us all that health care challenges can confront us when we least expect them.
Unfortunately, challenges to American health care will only increase if Congress fails to act on a provision in the Inflation Reduction Act (IRA) that is undermining medical research and innovation and putting the development of cures and treatments at risk.
Enacted in 2021, the IRA mandates a flawed drug-pricing model that is subjecting certain types of medicines to government price controls years sooner than other medications and treatments. The types of medicines that are being arbitrarily penalized in this way are those that come in the form of pills and capsules, which account for more than 90 percent of prescriptions in the United States and treat conditions and diseases that many patients live with – such as heart disease, cancer, depression and other neurological disorders.
This penalty for pill and capsule type medicines – what is now known as the “pill penalty” – means these small molecule drugs are subject to government price controls years sooner than large molecule drugs. Large molecule drugs are those that are generally injected or infused in a doctor’s office or other health care setting.
No surprise, but this pill penalty is already wreaking havoc. A new study by the Information Technology and Innovation Foundation found that this disparity in the IRA is undermining research and development (R&D) of new medical innovations, which could mean fewer or slowed advances to treat medical conditions that affect countless Americans, including those ranging from Parkinson’s to high blood pressure.
Similar negative effects of the pill penalty have been documented in numerous studies in recent years. For example, a University of Chicago study found that 188 fewer pill-type medicines will come to market because of the pill penalty.[1] Further, R&D funding for these types of drugs has dropped 70 percent since the IRA took effect.[2]
In addition to limiting development of new medicines, the pill penalty also undermines research into additional ways or “indications” an FDA-approved drug can help patients.
More than 50 percent of all pill medications receive at least one post-FDA approval indication and most of these occur, on average, 7.5 years after initial FDA approval. This means that if a medicine has been selected for government price-setting, there is less incentive under the IRA to explore additional ways that drug could help patients.[3]
Thankfully, there is hope.
Legislation now pending in Congress would fix this shortcoming in the IRA. The bipartisan Ensuring Pathways to Innovative Cures (EPIC) Act would encourage medical innovation and R&D by ensuring that pill-type “small molecule” medicines remain exempt from government price controls for 13 years, instead of the current nine years mandated by the IRA.[4] This would put small molecule research and innovation on a level playing field with large molecule drugs, which are governed by a 13-year exemption.
By undermining and stalling research, the pill penalty harms manufacturing and the jobs that manufacturing supports. The pill penalty undercuts medical progress, meaning the breakthroughs and options patients need and hope for will be restricted, and that means health outcomes will be worsened.
Given the health care challenges we face, fixing this harmful result of the IRA should be a top priority for Congress. We urge all Texas Congressional members to co-sponsor and support the EPIC Act to fix the pill penalty, spur innovation and help patients.
Editor’s Note: The above guest column was penned by Victoria Ford, MPA, president and CEO of the Texas Healthcare and Bioscience Institute (THBI). The column appears in the Rio Grande Guardian with the permission of the author.
[4]https://www.weworkforhealth.org/_files/ugd/b11210_230e6d57ca2640e09c7c4a3fe98f5e8c.pdf
The post Ford: Federal EPIC Act is Critical for Patients, Innovation appeared first on Rio Grande Guardian.
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