Mylan faces more EpiPen scrutiny as House committee demands info

EpiPen box

If Mylan was hoping that its new EpiPen copay assistance and authorized generic would stave off government probing, then it’s hoping in vain.

Another congressional commitee has piled on to Mylan and its EpiPen price hikes. The House Committee on Oversight and Government Reform called on CEO Heather Bresch Monday to account for her company’s actions--and hand over documents Mylan might prefer to keep under wraps.

Chairman Jason Chaffetz and Ranking Member Elijah Cummings demanded information on EpiPen’s pricing history, production costs, ad spending, profit margins. The basic nuts and bolts. And in a request that may make Bresch rue the day that she mentioned Mylan’s lobbying on EpiPen’s behalf, they also called for Mylan’s quarterly lobbying disclosures going back to 2007.

Chaffetz and Cummings’ demands follow a flurry of letters from Capitol Hill last week: Sen. Amy Klobuchar urged the Federal Trade Commission to investigate and demanded the Senate Judiciary Committee investigate.

Klobuchar joined with Sens. Charles Grassley, Patrick Leahy, Richard Blumenthal and Ron Johnson to ask FDA Commissioner Robert Cailiff why EpiPen has no competition--and suggested over-the-counter might be one way to go.

Then Sens. Clair McCaskill and Susan Collins, who head up the Senate Special Committee on Aging, demanded an “emergency briefing” from Bresch about the 400%-plus price hikes that lit up social media, and then lit a fire under Mylan and its leadership.

Now, it’s Chaffetz and Cummings, with their list of demands. In addition to the numbers, the committee wants any internal analyses about EpiPen’s future sales, communications about assistance programs going back to 2012, contracts and communications with manufacturers and distributors about EpiPen pricing, and so on.

That didn’t take long: Recall that when Valeant Pharmaceuticals’ big price hikes on Isuprel and Nitropress went public, Cummings and Sen. Bernie Sanders were leading the charge for more information. Months went by before other key committees got interested, and weeks more before all the demands for probes and hearings made their way into then-CEO Michael Pearson’s hands.

The difference in this case lies in the drugs themselves: EpiPen--a brand so common it’s used like Kleenex, one that millions of children carry in their backpacks and millions of parents must buy for back-to-school. Isuprel and Nitropress? Who’d ever heard of them before Valeant’s price hikes made waves?

In a follow-up letter issued Monday--after Mylan came up with an authorized generic for EpiPen at half price, seemingly overnight--Blumenthal called investigations into Mylan’s EpiPen policies “vitally necessary,” despite Mylan’s moves to make peace. And he raised one overriding question. Why does a scandal have to erupt before drugmakers roll back big price increases?

“A system in which public outrage is required to address these kind of unjust situations is not efficient,” Blumenthal said, in something of an understatement, given the tax dollars to be spent on hearings and the like. “When it comes to affording life-saving products for their families, consumers should not have to depend on the benevolence of monopolists.”

EpiPen may not have a monopoly for much longer: The FDA is likely to be motivated to help Teva address the questions that kept its alternative off the market. The small drugmaker looking to revive Auvi-Q certainly knows there’s a market crying out for its product. And other alternatives are in the works as well.

Meanwhile, Mylan will need to brace itself for public hearings and document dumps, and more media scrutiny. The company’s defense is just beginning. Oh, and by the way. The company spent at least $1.55 million on lobbying last year, according to data accumulated by the Center for Responsive Politics. So far this year? $875,000.

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