The Health Resources and Services Administration sent letters to drugmakers AbbVie and Amgen on Oct. 17 warning that they are in violation of a federal program by overcharging drug sales.
The HRSA, an HHS subagency, said the companies are surpassing the ceiling prices for drugs dictated by the 340B statute, a federal program that aims to cut certain outpatient drug costs for some hospitals and specialized clinics.
A spokesperson for Thousand Oaks, Calif.-based Amgen told Becker's the company is committed to the 340B program and said the drugmaker is concerned with "program integrity."
"In the decade since the HRSA expanded its contract pharmacy policy, the number of contract pharmacy arrangements in the 340B program has grown by a staggering 4,000 percent," the spokesperson said. "More than 50 percent of the profits generated by contract pharmacies are retained by for-profit companies, diverting resources from federal grantees and other covered entities that provide care to uninsured and vulnerable patients."
North Chicago, Ill.-based AbbVie did not immediately respond to Becker's request for comment.
The HRSA has sent similar warning letters to multiple pharmaceutical companies, including AstraZeneca, Eli Lilly and Sanofi. Several court decisions have been favorable to drugmakers, ruling the 340B statute does not apply to contract pharmacies.
AbbVie and Amgen have until Nov. 18 to plan to "restart selling, without restriction, 340B covered outpatient drugs at the 340B price to covered entities with contract pharmacy arrangements," the HRSA said in both letters.