Senators write Mylan CEO to demand ‘urgent briefing’ on EpiPen price

By Eric Sagonowsky Aug 24, 2016 2:37pm

Mylan’s EpiPen dilemma won’t be fading soon. After a rush by lawmakers to castigate the company for ‘outrageous’ price increases, Senators Susan Collins (R-ME) and Claire McCaskill (D-MO) are ratcheting up the fight.

The Senators on Wednesday asked for an “urgent briefing” with Mylan CEO Heather Bresch within two weeks in order to learn more about what drove the company to increase EpiPen prices a total of 480% since it acquired the med in 2007. The Senate Special Committee on Aging chair and ranking member, respectively, are requesting EpiPen pricing and market share analyses plus “any information reviewed or generated by Mylan’s Board of Directors relating to the drug over the same period.”

In their letter to Bresch, Sens. Collins and McCaskill cited EpiPen price increases from about $100 for a 2-pack back in 2007 to more than $600 today. But, they said, “during the same time period, the profitability of the product appears to have skyrocketed, raising concerns that price increases were not driven by increased costs of production or product improvements.”

Mylan said it'll comply with the senators' request in a brief statement to FiercePharma on Wednesday.

The senators join a growing chorus of lawmakers decrying the price of the epinephrine injections as reports on the price hikes escalated in recent days. Senators including Amy Klobuchar (D-MN), Chuck Grassley (R-IA), Bernie Sanders (I-VT), and Richard Blumenthal (D-CT) have each joined in by either calling for an investigation, demanding Mylan lower the price or requesting new info. Democratic presidential candidate Hillary Clinton also weighed in, calling the episode "the latest troubling example of a company taking advantage of its consumers."

EpiPens can be the difference between life and death. There's no justification for these price hikes. https://t.co/O6RbVR6Qim -H
— Hillary Clinton (@HillaryClinton) August 24, 2016

In a recent statement, Mylan said “ensuring access to epinephrine--the only first-line treatment for anaphylaxis--is a core part of our mission.” The company stressed that nearly 80% of commercially insured patients on the company’s patient assistance program got the med at no cost in 2015, and its school access program has distributed 700,000 injectors to 65,000 schools since 2012.

But the key might be that EpiPen is "the only first-line treatment for anaphylaxis,” as Mylan said. The company has raised prices as would-be competitors fell by the wayside, including Sanofi, which pulled its rival Auvi-Q, and Teva, which has experienced “significant” delays with its competitor due to an FDA rejection.

Five senators hit on that point in a Thursday letter to the FDA, questioning the regulator about potential competition and whether the agency has considered if EpiPen could become an OTC product.

Sens. Collins and McCaskill weren’t impressed with Mylan’s take, though, writing in their letter that it appears Mylan’s “assistance may be both inadequate and presented in a manner that could be misleading to consumers.”

The senators’ focus on Mylan comes after their committee previously took Valeant to task for price increases on Isuprel and Nitropress. Following months of delays and requests for documents and exec testimony, the committee in April finally had a date with then-CEO J. Michael Pearson, when it grilled him for 9 hours about the increases. And earlier this summer, the group requested info from naloxone providers--Mylan included--about why the price had increased on a med used to reverse the effects of opioids.

Mylan's shares took another dive after Clinton weighed in Wednesday afternoon, moving down about 6%.

- here’s the letter
- and Hillary Clinton's statement
- and the Senators' letter

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