- Sen. Charles “Chuck” Grassley is demanding to know why CMS didn’t crack down on EpiPen maker Mylan years ago when they first learned the drug was misclassified.
- The HHS Office of Inspector warned CMS in 2009 that EpiPen was improperly classified as a generic drug, allowing Mylan to avoid paying rebates in the Medicaid Drug Rebate Program.
- Mylan announced last month that it would pay $465 million to settle the charges with the U.S. Department of Justice over improperly classifying its EpiPen Auto-Injector as a generic drug, though the company did not admit to any wrongdoing.
Grassley expressed his concerns in a letter to Inspector General Daniel Levinson, recounting the 2009 report. The report noted a total of eight misclassified drugs, including EpiPen, out of a group of 75 drugs.
The Senate Judiciary Committee, which Grassley chairs, has scheduled a Nov. 30 hearing on EpiPen and the settlement. Among those invited to testify are Levinson and representatives from CMS, DOJ and Mylan.
“The taxpayers deserve answers on what happened between 2009 and now,” Grassley said in a statement. “It appears the EpiPen was misclassified for years, and CMS was notified of the problem. If no one did anything about the misclassification, why not?”
The DOJ’s investigation into Mylan’s handling of the Medicaid rebates follows harsh criticism of the drug firm’s repeated price hikes for the EpiPen Auto-Injector, which is the most widely used treatment for severe food allergies and anaphylaxis. Since 2007, the cost for package of two EpiPens has risen from $100 to $600, putting the life-saving treatment out of reach for many individuals who need it. Mylan is now under SEC investigation.
Mylan acknowledged no wrongdoing in the settlement, but announced in a regulatory filing that EpiPen will be classified as a branded drug beginning April 1, 2017. The company has said a generic version is forthcoming.