Congressional Committee Questions Mylan CEO Over EpiPen Controversy

September 21, 2016
Caroline Hroncich

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform on Sept. 21, 2016 to explain the company’s decision to increase the price of EpiPen more than 400%. The meeting comes after multiple members of Congress raised concerns about the price of the life-saving drug, which is used to treat anaphylaxis.

Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform on Sept. 21, 2016 to explain the company’s decision to increase the price of EpiPen more than 400%. The meeting comes after multiple members of Congress raised concerns about the price of the life-saving drug, which is used to treat anaphylaxis.

In her pre-released testimony, Bresch attempted to clarify exactly how much money Mylan makes off each EpiPen sale. Bresch said even though an EpiPen two-pack carries a $608 price tag after “rebates and various fees” Mylan only gets approximately $274. From that, Bresch said, Mylan pockets around $50 profit per pen or $100 for a two-pack. “The misconception about our profits is understandable, and at least partly due to the complex environment in which pharmaceutical prices are determined,” she said. “The pricing of a pharmaceutical product is opaque and frustrating, especially for patients.” Bresch estimates Mylan has spent approximately $1 billion on EpiPen since 2008.

Jason E. Chaffetz, United States representative for Utah and chairman of the committee, said Mylan’s argument isn’t convincing, since the five top executives at the company earned nearly $300 million dollars in the past five years. Bresch’s salary alone in 2015 topped off at $18 million. Representative Elijah Cummings also had choice words for the company, saying price increases were for the purpose of becoming “filthy rich” at the expense of constituents. Overall, the committee appeared to agree that the price of EpiPen was much too high, and requested additional information from Mylan on the company’s profit margins.

But Bresch says the company is taking steps to rectify the high price. Bresch said the company is launching a generic version of the EpiPen (priced at $300), increasing the EpiPen savings card program, and broadening eligibility for families to receive free EpiPens. She said the company is also working to extend the shelf life for EpiPen to approximately 24 months. In hindsight, Bresch said, she wishes the company had “better anticipated the magnitude and acceleration of the rising financial issues for a growing minority of patients who may have ended up paying the full [wholesale acquisition cost] price or more.”

Douglas C. Throckmorton, MD, deputy director for Regulatory Programs Center for Drug Evaluation and Research (CDER) also appeared before the committee to clarify the steps FDA is taking to make autoinjectors more readily available for patients. Throckmorton said FDA has approved four epinephrine autoinjectors, but there are only two currently on the market. EpiPen is a combination product, Throckmorton noted, and therefore can be more challenging than a typical drug product for pharma companies to produce. Throckmorton said FDA currently has 2300 generic drugs they are reviewing. He could not disclose how many of those generics are for epinephrine.

Mylan acquired EpiPen from Merck KGaA in 2007. In 2013, Congress required public elementary and secondary schools to keep the EpiPen on school property. According to a report in the New York Times, Mylan has also lobbied to get EpiPen on a list of preventative medical services. If Mylan is successful, this would eliminate out of pocket costs for patients, but would continue to allow the company to charge the $600 price tag.

Source: House Committee on Government Oversight and Reform