Mylan CEO faces grilling on Capitol Hill as senators unveil price-hike legislation

The EpiPen drama is moving into a congressional hearing room. Mylan CEO Heather Bresch is on the docket to testify next Wednesday for the House Committee on Oversight and Government Reform, where she’ll face questions about her company’s price hikes on the lifesaving epinephrine injector.

The FDA’s Doug Throckmorton will also appear, the committee said, to discuss ways to speed EpiPen alternatives to market.

The public hearing follows weeks of controversy over the cost of Mylan’s EpiPen, which steadily rose since Mylan took over marketing from Merck in 2007--to the point where its list price is now more than four times as expensive as it was in 2009, and more than 10 times the $57 cost when Merck unloaded the brand.

“We look forward to receiving answers next week from Mylan about its dramatic price hike for this life-saving medication,” Rep. Jason Chaffetz, committee chairman, and Ranking Member Elijah Cummings said in a statement. “We also plan to examine ways to encourage greater competition in the EpiPen market and to speed FDA’s approval of acceptable new generic applications.”

As with committee appearances by Valeant Pharmaceuticals executives and then-Turing CEO Martin Shkreli, America’s love-to-hate-him pharma bro, to answer similar questions, Bresch’s visit to Capitol Hill is likely to reignite public anger. And in this Presidential election year, the hearing could intensify calls for government action against drug-price increases.

Indeed, Sens. John McCain (R-AZ) and Tammy Baldwin (D-WI) now say they’re introducing a bill that would require companies to warn the Department of Health and Human Services of price hikes of more than 10%--and explain why the increases are necessary.

The McCain-Baldwin effort follows other legislative proposals, including a Senate bill introduced by Amy Klobuchar (D-MN) that would allow Medicare to directly negotiate prescription drug prices. Senate Republican Susan Collins (R-ME) and Democrat Claire McCaskill (D-MO) sponsored a measure that would speed development of generic copies to drugs that have little to no competition in the market.

And then there’s presidential candidate Hillary Clinton’s slate of proposals, already drawing fire in the pharma industry as a danger to innovation. Among her recommendations is a pricing panel that would regularly sift data for “outlier” price hikes and impose penalties on companies that can’t justify their increases.

Bresch has defended her company’s practices in multiple TV interviews by saying that payer rebates incentivize price increases and that pharmacy benefits managers, distributors and other “middlemen” account for more than half of EpiPen’s cost. To combat the bad publicity, Mylan has also increased its patient assistance and copay discounts, and announced it would roll out a generic at half of EpiPen’s list price.

Those moves, as well as Mylan’s explanations, have mostly fallen flat with politicians who’ve assaulted Bresch and her team amid the EpiPen furor. Several congressional committees are investigating, and federal agencies face calls for their own probes. Meanwhile, the letters and press releases from House members and senators continue to pile up.

Citing a 400% price increase on the epinephrine injection since 2009, Sen. Amy Klobuchar (D-MN) has called for the Senate Judiciary Committee and Federal Trade Commission to investigate the pricing practices. Sen. Chuck Grassley (R-IA) sought info on the topic--and has since complained about Mylan’s “incomplete” response. Sen. Bernie Sanders (I-VT), often an outspoken pharma critic, tweeted that "There's no reason an EpiPen, which costs Mylan just a few dollars to make, should cost families more than $600.”

Senators, representatives and committees in both houses started by demanding information on EpiPen pricing and marketing practices, urging the FDA to hustle competitors to market, and calling on the Federal Trade Commission to assess Mylan’s EpiPen monopoly.

Since then, they’ve asked the Centers for Medicare and Medicaid Services and the Department of Health and Human Services to look into how EpiPen price hikes have affected spending by Medicare, Medicaid and other federally-funded programs. Clinton also weighed in early on, calling the episode "the latest troubling example of a company taking advantage of its consumers."

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