Re-classification drops EpiPen price

The announcement is music to the ears for consumers and taxpayers who picked up the tab for the escalating price of a popular, brand name allergy drug that rose more than 400 percent over a decade, 2006-2016.

During the Obama administration, Iowans contacted my office regarding hair-raising sticker shock for the anti-allergy EpiPen device, the most widely prescribed epinephrine auto-injector in the United States.

Patients at risk for severe allergic reactions to insect bites, bee stings, foods, medications, latex or other triggers depend on around-the-clock access to the brand name prescription drug for life-saving emergency treatment.

Based on their concerns about the cost of EpiPens, I started digging for answers. Through my oversight work, I discovered that Mylan, the EpiPen distributor, classified its popular anti-allergy drug as a generic instead of as a brand name product in the Medicaid Rebate program. That incorrect classification allowed it to issue smaller rebates to government programs.

The Health and Human Services Inspector General found that the misclassification may have resulted in taxpayers overpaying for the drug by as much as $1.3 billion over 10 years. As chairman of the Senate Judiciary Committee, I?m working on legislative reforms to plug loopholes that allow pharmaceutical companies to game the system and keep drug prices artificially high.

I?ll continue my work to strengthen competition for prescription medications, hold the government and pharmaceutical companies accountable and increase transparency in drug pricing.

I?m glad the Food and Drug Administration (FDA) in August issued its stamp of approval for the first generic version of the most widely prescribed epinephrine auto-injector. The announcement comes just as the new school year is set to begin for tens of millions of students. Parents across the country are stocking up on anti-allergy devices to ensure kids are protected at school, carpools and elsewhere.

Policymakers and regulators must continue to focus on improving market-based competition.

That includes thwarting efforts by pharmaceutical manufacturers who try to unlawfully extend their monopoly over certain drugs by delaying generic entry and access to pharmacy store shelves.

What are your concerns about proposed mergers in the pharmaceutical supply chain?


From my chairmanship of the Senate Judiciary Committee, I have long championed robust and rigorous enforcement of the nation?s anti-trust laws to ensure the free marketplace is working effectively.

America?s system of free enterprise has made the United States into the biggest, most productive economy in the world. Consolidation and vertical integration in the agriculture, telecommunications and pharmaceutical industries has been a growing concern for me and my constituents.

That?s why I have called upon the Department of Justice (DOJ) and Federal Trade Commission (FTC) to thoroughly scrutinize proposed buy-outs and mergers and overall industry consolidation to ensure America?s farmers, consumers and patients aren?t dealt an unfair hand in the aftermath of a transaction.

Consider the proposed merger between Cigna Corporation with Express Scripts Holding Company and CVS Health Corporation with Aetna, Incorporated. According to a new report from the Kaiser Family Foundation, if these two mergers are approved, just four entities would capture 71 percent of all Medicare Part D enrollees and 86 percent of stand-alone drug plan enrollees.

American consumers already swallow substantial increases in drug prices across the board.

As a federal lawmaker, I work to enact policies that will foster innovation in the U.S. health care delivery system to drive down drug prices and deliver better patient outcomes. Vertical integration isn?t necessarily a bad thing and can often lead to innovation, increased efficiencies and consumer benefits.  But if left unchecked, it may also lead to increased barriers that hinder efficiencies and competition. As one of Iowa?s U.S. senators, I pay special attention to the potential impact on underserved, rural areas.

I?ve asked the Antitrust Division at DOJ to carefully examine these proposed mergers and the FTC to assess overall pharmaceutical supply chain consolidation. The last thing consumers can afford is paying even higher prices when they go to fill their prescriptions.