- Members of two U.S. congressional committees, Sen. Ron Wyden of Oregon and Rep. Frank Pallone of New Jersey, have sought an investigation into whether Mylan inappropriately classified its EpiPen as generic under the Medicaid rebate program.
- Mylan has already been in a storm of controversy for having incrementally raised the price of the EpiPen from under $100 in 2007 to now over $600, drawing political scrutiny and calls for increased industry oversight.
- The price scrutiny led to questions about how the increased cost would impact state Medicaid programs, which in turn led to questions about how and why the brand-name product is getting away with calling itself generic and thereby paying the far lower 13% rebate of the average manufacturer price to Medicaid rather than the minimum 23.1% rebate required of branded products, The New York Times reported.
The classification reportedly originated from a decades-old agreement from a Medicaid official that a generic designation was appropriate because the EpiPen uses the generic drug epinephrine, the New York Times reported. However, the EpiPen also relies on its patented auto-injector.
Mylan did not elaborate on the reasoning for the classification, though it responded to the latest controversy with a statement that the company "has complied with all laws and regulations regarding the Medicaid rebate classification." It added that it will work to comply with a new rule in Medicaid rebate law requiring submission of an application for non-innovator status, by April 1, 2017. "It would be premature to comment further on this issue until CMS makes its decision on our application," the company said.
Matt Salo, the executive director of the National Association of Medicaid Directors, told Reuters that the classification could be costing Medicaid programs tens of millions of dollars.
The issue could have a broader reach if it turns out that the EpiPen is not the only product with a questionable classification, and raises questions about the government's oversight, Sen. Amy Klobuchar of Minnesota told the Times.