September 21, 2016

Udall Presses FDA to Expedite Alternative Treatments to EpiPen in Wake of ‘Astronomical' Price Hikes

At hearing, tells stories of New Mexicans struggling to afford the life-saving medical product; 'No one should have to go without a medically necessary product because of how much it costs'

WASHINGTON - Today, at a hearing of the Appropriations Subcommittee overseeing the Food and Drug Administration (FDA), U.S. Senator Tom Udall pressed the agency to safely expedite alternative treatments to the EpiPen Auto-Injector, which delivers a life-saving dose of epinephrine in the event of a severe allergic reaction. Mylan, the EpiPen manufacturer, has raised the price to over $600 for a package of two in just the last seven years, causing an outcry among people in New Mexico and across the country who have been directed by their doctors to carry the EpiPen.

The Senate hearing came the same day that Mylan's CEO Heather Bresch told members of a U.S. House of Representatives committee that her company has no plans to lower prices. Udall said he has been inundated with letters and calls from anxious New Mexico families who can no longer afford EpiPens due to these unconscionable price increases. And he shared some of their stories today while questioning Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, urging her agency to step in and provide relief.

"I've heard from worried parents across the state like Paige Vest from Truth or Consequences, New Mexico. Paige's daughter suffers from a severe peanut and tree allergy-she needs to carry an EpiPen with her at all times to prevent a possible life threatening reaction," Udall said. "Paige wrote to me about her family's struggle to pay for the medication. She even had to change jobs in order to get insurance that would help cover the cost.

"Linda Thompson, from El Prado, New Mexico, wrote to me that because of rising costs in recent years, she has stopped buying and carrying an EpiPen," Udall continued. "She is forced to go against the advice of her doctor who prescribed the EpiPen after a severe reaction to a bee sting...No one should have to go without a medically necessary product because of how much it costs," Udall concluded.

Udall has publicly criticized the company's decision to repeatedly and significantly raise the price for the EpiPen. In August, he sent a letter to Heather Bresch criticizing Mylan's business practices and questioning the efficacy of the patient assistance programs the company recently expanded. And last week, he and other members of the N.M. Congressional delegation sent a letter to FDA Commissioner Robert Califf calling on the FDA to utilize all available resources to build a robust pipeline of EpiPen alternatives to provide options for families struggling to afford this critical medical product.

Click here to watch a video of his remarks and questions.

Below are Udall's remarks as prepared for delivery:

Thank you, Chairman Moran and Ranking Member Merkley.

Dr. Woodcock, it seems like every few months we hear about another pharmaceutical company raising the cost of a certain drug or device to a new astronomical price.

The EpiPen auto injector is the most recent to draw national attention. The EpiPen has become so expensive that families in New Mexico and across the country are struggling to afford it, even though their doctors say they must carry it in the event of an allergic reaction. But Mylan, the manufacturer, has increased the price of EpiPens in the United States by over 480%, since 2009.

I've received messages from constituents in New Mexico who are directly impacted. I've heard from worried parents across the state like Paige Vest from Truth or Consequences, New Mexico. Paige's daughter suffers from a severe peanut and tree nut allergy-she needs to carry an EpiPen with her at all times to prevent a possible life threatening reaction. Paige wrote to me about her family's struggles to pay for the medication. She even had to change jobs in order to get insurance that would help cover the cost.

I'm also worried about the impact these price increases will have on families who can no longer afford the EpiPen.

Linda Thompson, from El Prado, New Mexico, wrote to me that because of rising costs in recent years, she has stopped buying and carrying an EpiPen. She is forced to go against the advice of her doctor, who prescribed the EpiPen after a severe reaction to bee sting.

No one should have to go without a medically necessary product because of how much it costs-and that's why I wrote to Commissioner Califf last week, along with members of the New Mexico congressional delegation, requesting that the FDA utilize all available resources to build a robust pipeline of EpiPen alternatives.