Heather Bresch

EpiPen pricing and retirement

In 2016, Mylan’s pricing of the EpiPen, used to treat anaphylaxis (severe allergic reactions), was severely criticized. Mylan had secured the rights to the nearly 50-year-old EpiPen as part of the Merck KGaA deal in 2007. At that time annual sales were around $200 million.

Bresch launched an advertising campaign to increase awareness of “EpiPen” as a treatment for anaphylaxis; the company also successfully lobbied the FDA to broaden the label to include risk of anaphylaxis and in parallel, successfully lobbied Congress to generate legislation making EpiPens available in schools and other public places. The company hired the same lobbyists that Medtronic had used for its defibrillator legislation.

From 2007 to 2016, Mylan increased the price of EpiPens by 461 percent, from about $100 for a package of two pens to about $600. By the first half of 2015, Mylan had an 85% market share of such devices in the U.S., and in that year sales reached around $1.5 billion and accounted for 40% of Mylan’s profit.

The price increase was met with widespread criticism of Bresch and Mylan. Bresch explained at the 2016 Forbes Healthcare Summit that Mylan’s price increases were justified by the many improvements she claimed the company had made to the product.

Amid this backlash, Bresch led Mylan to introduce a generic version of the device which sells for half the price of the brand-name device. The generic version in 2016 remained more expensive than the original brand version of EpiPen prior to Mylan’s purchase of the rights, even when accounting for inflation.

In July 2019, Bresch announced that she would retire in 2020 after Mylan merged with Upjohn. The merger was completed in November 2020 and Bresch stepped down. The new company was named Viatris. According to the Pittsburgh Business Journal, when she left Mylan, she was the second most highly paid executive in the area of Pittsburgh, and received a “golden parachute” estimated at $30.8 million.

In 2021, a case was ongoing to determine whether Mylan had attempted to monopolize the EpiPen market, with both Mylan N.V. and Bresch being sued on racketeering claims and anti-trust claims. The lawsuit, which consolidated several consumer cases, was moved to federal court in Kansas City in 2017. In February 2020, the lawsuit moved ahead as a nationwide class action.

On June 24, 2021, a federal judge tossed the racketeering claims and some of the antitrust claims, also dropping RICO claims against Bresch. The case went on trial on September 7, 2021. On September 7, 2021, Ryan Grim of The Intercept reported that during an ongoing racketeering case involving Mylan and Bresch, “newly released court documents show [Bresch] discussing a deal with Pfizer to eliminate a chief competitor to EpiPen, clearing the way for major price hikes.”

The 2010 and 2011 email discussions, unsealed by the judge, showed Bresch’s assistant discussing divesting from Adrenaclick after the closure of the Pfizer/King deal. They “also show Bresch approving a scheme to force customers, captured by the company’s monopoly, to purchase two EpiPens at once, regardless of medical need.”