Reviewing the Rising Price of EpiPens

Full House Committee on Oversight and Government Reform
Full House Committee on Oversight and Government Reform
Hearing Date: September 21, 2016 2:00 pm 2154 Rayburn HOB

House Committee on Oversight and Government Reform will hold a bipartisan hearing with officials from Mylan, which dramatically increased its prices for EpiPens.
 
“There is justified outrage from families and schools across the country struggling to afford the high cost of EpiPens.  We look forward to receiving answers next week from Mylan about its dramatic price hike for this life-saving medication.  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,” Chaffetz and Cummings said in a joint statement.  “Our goal is to work together to ensure that critical medications, like the EpiPen, are accessible and affordable for all of our constituents.”
Ranking Member Cummings called for the hearing on August 25, 2016, and other Members of Congress also requested a hearing on this issue, including Rep. Grace Meng, Rep. Stephen Lynch, Rep. Tammy Duckworth, and Rep. Peter Welch.
Two weeks ago, Chaffetz and Cummings sent a bipartisan letter to Heather Bresch, the CEO of Mylan, requesting documents and communications regarding the increasing price of EpiPens, including documents relating to the company’s revenues from sales of EpiPens since 2007, manufacturing costs, and the amount of money the company receives from federal government health care programs.  The company has indicated that it will begin producing documents this week.

TAKEAWAYS:

  • Despite promises the Affordable Care Act (ACA) would lower health care costs, the ACA has exacerbated the costs of prescription drugs as consumers shift to high-deductible plans.
  • The price for a two-pack of EpiPens has increased more than 500 percent in the last decade, rising from $100 to more than $600.
  • A lack of transparency exists in the drug-pricing market and Mylan’s finances and figures did not add up under scrutiny.
  • The epinephrine auto-injector market lacks the competition necessary to lower costs for consumers. FDA could not reveal how many applications for new entrants into the epinephrine auto-injector market are pending or how long those applications have been in process.

PURPOSE:

  • To examine the steep price increases in the EpiPen product.
  • To examine the FDA’s role in promoting competition in this market and impediments to the timely review and approval of new entrants

BACKGROUND:

  • Mylan’s Epipen has a dominant market share of epinephrine auto-injectors and additional entrants face a complex regulatory framework at FDA.
  • Generic drugs play an important role in offering affordable alternatives to costlier brand named drugs like the EpiPen.

KEY VIDEOS:

Oversight and Government Reform Committee Chairman Jason Chaffetz (R-UT): “It’s unprecedented to raise the price 500 percent, so you’re raising it to lower it but your net revenue goes up.”

Rep. Mick Mulvaney (R-SC): “So if you can really charge $600 for it and people will pay for it, why aren’t more people rushing in to make this stuff, so they get a piece of this huge market? Because it’s too hard to get the darn stuff approved and that’s what I wish we were talking about.” 

Rep. Tim Walberg (R-MI):  “Won’t this in fact just shift the full cost of EpiPens to government payers such as Medicaid, Medicare, health insurers, employers, eventually leading to an overall increase in premiums and other co-pays of consumers?” 

Witnesses and testimonies

Name Title Organization Panel Document
Heather Bresch Chief Executive Officer Mylan, Inc. Document
Dr. Doug Throckmorton Deputy Director, Center for Drug Evaluation and Research Food and Drug Administration Document