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Manchin’s Continued Pressure Leads To Action Against Pharmaceutical Companies On Behalf Of Low-Income West Virginians

Source: United States Senator for West Virginia Joe Manchin

September 23, 2021

Washington, DC – After months of pressure from U.S. Senator Joe Manchin (D-WV), the Health Resources and Services Administration (HRSA) alerted six pharmaceutical manufacturers that due to their violations of the 340B Drug Pricing Program requirements – which continue to harm low-income West Virginians by preventing them from accessing safe and affordable medications – HRSA has contacted the Department of Health and Human Services (HHS) Office of the Inspector General in accordance with the 340B Ceiling Price and Civil Monetary Penalties Final Rule. Since the manufacturers still refuse to comply with the 340B Drug Pricing Program, the HHS Office of the Inspector General may now assess whether financial penalties are warranted.

“I thank HRSA for their continued efforts to correct the unacceptable behaviors of six pharmaceutical manufacturers who are blatantly violating the statutes they agreed to under the 340B Drug Pricing Program. Many West Virginians rely on this program to get their vital medications at an affordable price. This urgent issue must be fixed, and I will continue to work with HRSA to ensure low-income West Virginia families have the life-saving medications they need,” said Senator Manchin.

The 340B Drug Pricing Program was created in 1992 to require drug companies who participate in the Medicaid program to provide discounted drugs to certain healthcare providers that serve vulnerable populations. During the COVID-19 pandemic, at least six drug companies have taken steps to deny access to discounted drugs for 340B covered entities that use contract pharmacies, which HHS has determined is in violation of the 340B statute. These actions are restricting access to medications for patients who need them the most, especially as the ongoing COVID-19 pandemic presents additional barriers for access to vital medications and care. These changes are also negatively affecting West Virginia health centers and healthcare providers, who use the much-needed savings from the 340B Drug Pricing Program to stretch scarce federal resources and to pass benefits onto patients in the form of low-cost drugs and expanded access to essential patient care.

On June 9, 2021, Senator Manchin questioned HHS Secretary Xavier Becerra on the importance of ensuring low-income West Virginians have access to affordable medications through the 340B Drug Pricing Program.
On May 19, 2021, after Senator Manchin pressed HHS to protect access to safe and affordable medications for low income West Virginians, HHS determined six pharmaceutical companies are violating the 340B Drug Pricing Program, which ensures access to medications for low-income West Virginians and Americans.
On March 1, 2021, Senator Manchin requested that then HHS Secretary nominee Becerra enforce the 340B statute and require pharmaceutical companies provide the mandated discounts for covered entities.
On September 23, 2020, HHS began an investigation of Eli Lilly and Company, one of the many drug makers who made changes to restrict access to the 340B Drug Pricing Program for safety net health providers. This decision came after Senator Manchin sent a letter pressing HHS to protect access to the program.
On September 15, 2020, Senator Manchin pressed HHS Secretary Alex Azar to respond to recent changes by drug companies to restrict access to the 340B Drug Pricing Program for safety net health providers.
The new letters from HHS to the pharmaceutical companies can be found here.