Updated: Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan’s EpiPen

Posted 22 August 2016 By Zachary Brennan

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Sen. Amy Klobuchar (D-MN) this week called on the Senate Judiciary Committee to hold a hearing to investigate the more than 400% price increase of Mylan’s EpiPen, a potentially life-saving auto-injector for those suffering from severe allergies.

Klobuchar joined fellow Democrat on the Judiciary Committee, Sen. Richard Blumenthal (D-CT), as well as former presidential hopeful Sen. Bernie Sanders (D-VT) in expressing outrage over the price hikes. And on Wednesday, Democratic presidential nominee Hillary Clinton condemned Mylan for hiking the price of the EpiPen "to an all-time high."

Sens. Claire McCaskill (D-MO) and Susan Collins (R-ME) sent a letter on Wednesday to Mylan CEO Heather Bresch (daughter of West Virginia Sen. Joe Manchin (D)) requesting "any analysis used by Mylan relating to the pricing or market share of EpiPen since 2007, along with any information reviewed or generated by Mylan's Board of Directors relating to the drug over the same period," in addition to a briefing to the US Senate Committee on Aging some time in the next two weeks.

In addition, Sen. Chuck Grassley (R-IA), also a member of the Judiciary Committee, sent a letter on Monday to Bresch raising concerns about the price increases and requesting more information on how Mylan determined the price of EpiPens, as well as Mylan's advertising budget for EpiPen for the first half of 2016 and 2015.

"In the case of EpiPens, I am concerned that the substantial price increase could limit access to a much-needed medication. In addition, it could create an unsafe situation for patients as people, untrained in medical procedures, are incentivized to make their own kits from raw materials," Grassley wrote.

According to Klobuchar, in 2009, the price of a pack of two EpiPens (prescribed over 3.6 million times last year) made by the Pennsylvania-based company was $100, though Mylan, which has a virtual monopoly on the product, has since raised the price to $500, with some patients reportedly seeing prices as high as $600.

Mylan spokeswoman Lauren Kashtan told Focus, however, that in 2015, nearly 80% of commercially insured patients using a Mylan savings card received EpiPen Auto-Injector for free. The company also uses a school initiative that has distributed more than 700,000 free EpiPens,  and more than 65,000 schools, approximately half of all US schools, have participated in the program, she said. 

When Mylan bought EpiPen in 2007, the devices brought in about $200 million in annual sales, according to Bloomberg, whereas the auto-injector’s annual revenue now is more than $1 billion.

The price increase comes as Mylan has gained market share as Sanofi’s competitor Auvi-Q was recalled last year and Teva’s generic version of the EpiPen was rejected by FDA in March.

Klobuchar added: “Not only should the Judiciary Committee hold a hearing, the Federal Trade Commission should investigate these price increases immediately. The Commission should also report to Congress on why these outrageous price increases have become common and propose solutions that will better protect consumers within 90 days."

Andy Slavitt, acting administrator for the US Centers for Medicare and Medicaid Services (CMS), also tweeted (with a link to Forbes’ coverage of the EpiPen price hike) on Sunday: “We can make drug inflation more transparent & address unchecked increases without damaging innovation.”

“There's no reason an EpiPen, which costs Mylan just a few dollars to make, should cost families more than $600,” Sanders tweeted last week.

And on the House side, Rep. Grace Meng (D-NY) sent a letter on Tuesday to the House Committee on Oversight and Government Reform requesting a hearing on the price increases.

"The free market can be a wonderful engine for good in our society, and it has certainly led to the production of countless medical innovations," Meng wrote. "We must be vigilant, however, to not cross the line of price-gouging, especially when a product has been around for a generation and is incredibly cheap to produce."

Legislation

A couple of bills already introduced in 2015 could help to bring the price of the EpiPen down, though it’s unclear if any of those bills will make it into law as the November election looms.

The Medicare Prescription Drug Price Negotiation Act of 2015 would allow Slavitt’s CMS to negotiate for the best possible price of a drug, though Republicans and industry trade group PhRMA have opposed the measure.

Last September, Klobuchar and Grassley (R-IA) also reintroduced a bill that would prevent branded and generic drug companies from forging deals that delay the launch of generics. 

Editor's note: Article updated on 8/23/16 with details of Meng's letter to House oversight committee. Article updated on 8/24/16 with details of Hillary Clinton's comments and Sens. Collins and McCaskill's letter.

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Categories: Drugs, Medical Devices, Crisis management, Government affairs, Quality, News, US, FDA, FTC, Business and Leadership

Tags: EpiPen, Mylan, Andy Slavitt, Bernie Sanders

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