May 19, 2021

After Manchin Presses for Action, HHS Says Six Pharmaceutical Companies Violate Program That Provides Affordable Medications for Low-Income West Virginians

Washington, DC – After U.S. Senator Joe Manchin (D-WV) pressed the Health and Human Services (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.

“This determination by HHS is a step in the right direction for West Virginians who rely on the 340B program to access affordable medications through their healthcare providers,” said Senator Manchin. “These six companies blatantly violated the statutes they agreed to and have impacted many West Virginia families that were already struggling to find and pay for essential medications during the COVID-19 pandemic. It is unacceptable that these companies implemented these policies in the first place, and I will continue fighting to ensure these companies return to providing low-income families with vital life-saving medicines.”

The 340B Drug Pricing Program was created in 1992 to mandate drug companies who participate in the Medicaid program provide discounted drugs to certain healthcare providers that serve vulnerable populations. The 340B program provides much needed savings to health providers to stretch scarce federal resources as far as possible, allowing more patients to access affordable medication. The savings are passed on to patients through low-cost drugs and expanded access to essential patient care.

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, which have already been more difficult to purchase during the ongoing COVID-19 pandemic. These changes are also negatively affecting West Virginia health centers and healthcare providers who rely on this program to provide vulnerable West Virginians with quality, affordable care.

“On behalf of all West Virginia pharmacies and healthcare providers, I want to thank Senator Manchin and his staff for their work to address the 340B crisis. When patients who rely on life saving insulin suddenly find themselves unable to afford this medication at their local pharmacy due to a lack of 340B pricing, the impact is catastrophic for the patients’ health and the overall cost to the healthcare system. The refusal of manufacturers to obey the law and participate in the 340B program has devastated the safety net providers that care for those who need the most help in Appalachia,” said Lynne Fruth, President and Chairman of Fruth Pharmacy.

“We commend Senator Manchin for his leadership in encouraging the Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) to take decisive action against drug companies that violated the 340B drug program. The 340B program plays a critical role in helping eligible West Virginia hospitals provide a wide range of comprehensive services to vulnerable patients and communities, many of which have been the hardest hit by the COVID-19 pandemic. Senator Manchin’s involvement demonstrates his continued commitment to protecting West Virginia’s most vulnerable patients and preserving access to care in communities throughout the Mountain State,” said Jim Kaufman, President and CEO of the West Virginia Hospital Association.

“We are delighted that HHS Secretary Xavier Becerra, through HRSA, has taken bold steps to stop the attack by pharmaceutical companies on the 340B program,” said Sherri Ferrell, CEO of the West Virginia Primary Care Association. “The undermining of the 340B program by pharmaceutical companies and pharmacy benefit managers has taken its toll on West Virginia’s community health centers and their contract pharmacy partners. We are also thankful for the backing of the state’s Congressional delegation regarding the 340B program. The 340B program allows health centers to continue providing prescription drugs to those in need and to stretch scarce resources as far as possible to help the underserved.”

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 23rd, 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 15th, 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 letters from HHS to the pharmaceutical companies can be found here.