WASHINGTON– U.S. Sen. Chuck Grassley of Iowa today released the following statement on the Food and Drug Administration’s (FDA) approval of the first generic version of the EpiPen, an emergency auto-injector of epinephrine used to treat severe, life-threatening allergic reactions

“This announcement is great news for millions of Americans who depend on life-saving anti-allergy devices. Affordability often makes the difference for parents purchasing medications or treatments their children need. Many Americans simply can’t afford to pay hundreds or even thousands of dollars for their prescriptions. Competition lowers prices and increases options. Allowing generic drugs to go to market is the best way to make them more affordable and accessible.

“I’ve worked to pass bipartisan legislation that would improve market-based competition and curb the efforts of pharmaceutical companies to game the system and keep prescription drug prices artificially high. This announcement will help millions of Americans suffering from life-threatening allergies. I’ll continue my work to strengthen competition for prescription medications, hold the government and pharmaceutical companies accountable and increase transparency in drug pricing to make sure Americans are getting a fair shake.”

Grassley is a long advocate for lower prescription drug prices and has been a vocal critic of EpiPen’s exorbitantly high cost.

During the Obama administration, Iowans regularly contacted Grassley by phone, email and at his annual 99 county meetings about the difficulties they faced paying for the anti-allergy EpiPen device. After conducting oversight of the issue, Grassley learned that Mylan, EpiPen’s distributor, classified its popular anti-allergy medicine as a generic instead of as a brand name product in the Medicaid Drug Rebate program. That incorrect classification allowed it to issue smaller rebates to government programs, such as Medicaid. Worse, taxpayers were on the hook for exorbitant overpayments for the better part of a decade starting in 2006. The costly, anti-competitive practices were confirmed by the government’s internal watchdog when it found that taxpayers may have overpaid for the EpiPen by as much as $1.27 billion over 10 years. 

Grassley continually pressed for the accurate classification of prescription drugs under the Medicaid Drug Rebate Program. He sought answers from the Centers for Medicare and Medicaid Services (CMS) on whether it sought to recoup tax dollars overpaid for EpiPens from Mylan. He sent a follow-up letter after receiving no response from CMS, reiterating his initial request for information.

Grassley continued pressing for answers when news broke that EpiPen maker Mylan was in discussions with the Department of Justice (DOJ) to settle a case and repay the taxpayers for over-charging for EpiPen. Grassley sent a letter to then-President-elect Trump urging appropriate classification under the Medicaid Drug Rebate Program. That letter is available here. Grassley also sent a letter to the outgoing Administration on the issue, which is available here. His Oct. 3 letter to the prior administration on the EpiPen misclassification is available here. When the Department of Justice and EpiPen maker Mylan settled its case over the drug’s misclassification, Grassley issued a statement of disappointment, saying it shortchanged taxpayers.

On behalf of Iowans, Grassley also wrote to Iowa Attorney General Tom Miller seeking clarification regarding his office’s ability to determine the value of reimbursement to the state necessary to make Iowa whole from EpiPen’s apparent misclassification. A few months later, Grassley followed up with another letter seeking additional details and accompanying documentation regarding the state’s receiving $1.5 million as part of a DOJ settlement with Mylan.