Mylan is facing a U.S. antitrust investigation over whether it blocked generic competition to its controversial EpiPen epinephrine autoinjector, according to a Bloomberg report. The company has received a request for information from the Federal Trade Commission (FTC) as part of a preliminary inquiry.
The FTC is looking into whether Mylan’s practices violated antitrust laws, including whether minor changes it made to the EpiPen effectively shielded it from competition from lower-priced products. Another area of scrutiny is whether Mylan entered any agreements that delayed cheaper versions of the EpiPen from coming to market.
The FTC inquiry into the EpiPen is in its early stages and may not result in an enforcement action, the Bloomberg article points out.
Meanwhile, Mylan is also involved in a Justice Department criminal investigation into price-fixing by the generic-drug manufacturer, although it’s not clear whether the company will be a target of the probe.
Since acquiring the EpiPen in 2007, Mylan has raised the price several times to more than $600 for a two-pack from approximately $57 per shot. In recent years, the company stopped selling single EpiPens in favor of twin-packs and has promoted the product by getting schools to stock it for emergencies.
The pen now includes a nonremovable needle cap that prevents users from accidentally sticking themselves or others, Bloomberg says. That advancement and others were patented within the last eight years, and Mylan argues that they are critical to the pen’s safety and functionality. Mylan’s patent on the EpiPen will expire in 2025.
Source: Bloomberg; January 30, 2017.