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E&C; Release: As EpiPen Costs Soar, E&C; Leaders Press FDA for Answers on Agency's Regulatory Process for Generic Drugs

8/29/16

 
 

E&C Release: As EpiPen Costs Soar, E&C Leaders Press FDA for Answers on Agency’s Regulatory Process for Generic Drugs

For Immediate Release: August 29, 2016
Contact: Carly Atchison 202.225.2301

Washington, D.C. - Today, the House Energy & Commerce Committee issued the following press release:

As EpiPen Costs Soar, E&C Leaders Press FDA for Answers on Agency’s Regulatory Process for Generic Drugs

In Light of Patients Facing Higher Costs for EpiPens, E&C Presses FDA On What Policies Are Thwarting Competition in the Market

WASHINGTON, DC – Following concerns about soaring out-of-pocket costs for EpiPens, Energy and Commerce Committee leaders today sent a letter to FDA Commissioner Dr. Robert Califf regarding generic drugs at FDA and ensuring we have a competitive prescription drug market. The letter identifies a series of questions focused on the issues involved in bringing competitors to the EpiPen onto the market. The letter was sent by full committee Chairman Fred Upton (R-MI), Health Subcommittee Chairman Joseph Pitts (R-PA), and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA).

“In 2012, the Energy and Commerce Committee led the effort to pass the first generic drug user fee authorization (GDUFA) program,” wrote Upton, Pitts, and Murphy. “The goal of the legislation was to expedite the review of abbreviated new drug applications (ANDAs) and clear the backlog of applications at the agency. Improving the generic drug review process will promote competition and ultimately lower the cost of prescription drugs for America’s patients.”

“We are concerned about the lack of generic competition in the epinephrine auto-injector market,” continued the leaders, posing a series of questions about how FDA’s policies can inhibit competition in the generic drug market.

Last week, committee leaders raised concerns about the soaring costs of life-saving EpiPens. “EpiPens are a critical and often only option for saving kids from the brink of death during severe allergic reactions. And the soaring costs that patients are now facing for Epi-Pen Auto-Injectors is cause for alarm,” said Upton.

ClickHERE to read a copy of the letter.

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Murphy Press | Congressman Tim Murphy (PA-18)
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