The Canonsburg, Pa.-based company reportedly responded to the allegations that it improperly fought off competition, saying “any suggestion that Mylan took any inappropriate or unlawful actions to prevent generic competition is without merit.”
Mylan has repeatedly challenged rival Teva Pharmaceutical’s efforts to gain regulatory approval for its generic EpiPen device, asserting that Teva’s version is not an exact copy – it has 2 caps, which is not identical to Mylan’s single-cap device. The company argued that because of the design difference, a distressed patient may not be able to quickly use Teva’s version if they were trained to use Mylan’s device.
Last year, the FDA rejected Teva’s application for approval.
The FTC’s preliminary probe is reportedly focused on whether small changes the company made to the EpiPen to extend its patent effectively prevented competition from lower-priced products. The FTC is also looking into whether Mylan inked any agreements that delayed cheaper versions of its device from coming to the market.
MYL shares dropped in afternoon trading activity yesterday, but recovered and closed down -0.9%. In morning activity today, the company’s shares were trading at $37.32 apiece, up +2.7%.
Mylan has been under fire since August when reports revealed it hiked the price of its EpiPen device 500% since it acquired the auto-injector in 2007. In response to widespread criticism from politicians and lawmakers, Mylan said in August that it would launch a discounted generic version of the device and expand its patient assistance program.
In mid-December, the company announced that its generic EpiPen will sell for $300 per two-pack, which is a 50% discount compared to the price of the brand name device.
The company said in October last year that it agreed to pay $465 million to settle claims that it underpaid Medicaid for its EpiPen auto-injector by misclassifying the device as a generic. The Centers for Medicare & Medicaid Services said it spent $797 million on the emergency allergy treatment between 2011 and 2015, including rebates.