Mylan Pharmaceuticals, generics specialist headquartered in both the US and the UK, has paid $465m to the US government to settle claims that it improperly classified its EpiPen Auto-Injector as a generic product to gain rebates from the public health insurer Medicaid, while at the same time billing it as a brand-name drug for other purposes. The classification as a generic meant it coould grant lower rebates to the insurer.

Mylan has neither admitted nor denied liability. The company has come under scrutiny of late, most recently in the US Congress, for raising the price of the allergic shock treatment nearly 500% since 2007. The current price of the device is $608 for a two-pack. In a statement, Heather Bresch, Mylan’s CEO, called the settlement “another important step” in the company’s efforts to resolve questions surrounding the EpiPen Auto-Injector and all matters related to the device. According to a regulatory filing, the EpiPen will be classified as a branded drug from Apr. 1, 2017.

"The agreement,” Bresch added, is in addition to the “significant steps” Mylan has taken in relation to EpiPen Auto-Injector over the past several weeks. These include the pending launch of a generic version and expansion of patient access programs for the product. “Entering into this settlement is the right course of action at this time for the company, its stakeholders and the Medicaid program," she said.

Not all US lawmakers were satisfied with the deal. "This settlement is a shadow of what it should be –lacking real accountability for Mylan’s apparent lawbreaking," said Senator Richard Blumenthal of Connecticut. Blumenthal said Congress should investigate whether Mylan violated the law.