- Mylan is making further acts of contrition for the pricing of its EpiPen auto-injector, reaching a settlement with the U.S. Department of Justice for $465 million.
- The company admitted no fault, but paid the fine to settle the matter of whether the EpiPen was wrongly classified with the Centers for Medicaid and Medicare Services (CMS) under the Medicaid Rebate statute.
- Mylan contends that the epinephrine device was already classified as a non-innovator product before Mylan acquired the drug in 2007 "based on longstanding written guidance from the federal government."
The EpiPen has long been classified as a "non-innovator" drug under the Medicaid Rebate statute, leading to the program overpaying for the drug. EpiPen will now be classified as an "innovator" product.
"This agreement is another important step in Mylan's efforts to move forward and bring resolution to all EpiPen Auto-Injector related matters," said embroiled CEO Heather Bresch in a statement.
The company has been fending off accusations of price-gouging for its life-saving allergic reaction device for almost two months after it was revealed that Mylan raised the price of a two-pack from $100 several years go to more than $600 currently.
Mylan has acted quickly to staunch the bleeding – immediately responding with a $300 discount for uninsured and underinsured patients, as well as putting a branded generic into the works that will also be half the cost.
Yet, Bresch has still had to face concerns and questions from several members of Congress and was vilified for her handling of the situation during her appearance in front of the government body.
Mylan is just the latest company to come under fire for its drug pricing practices. Other companies like Valeant and Turing faced an onslaught of negative press after being confronted about their egregious price increases for older drugs.
Mylan noted in a filing with the Securities and Exchange Commission that the Division of Enforcement of the SEC is requesting documents regarding the company's exchanges with CMS over the classification of the EpiPen.