Garrett Calls on FDA to Answer Questions About EpiPen Monopoly


Date: Sept. 21, 2016
Location: Washington, DC

Rep. Scott Garrett (NJ-05) called on the Food and Drug Administration (FDA) to express concerns over the near monopoly currently held by Mylan Pharmaceuticals on the EpiPen (epinephrine injection) which is used in the treatment of severe allergic reactions. The price of these life-saving devices has skyrocketed recently, making them unaffordable for many Americans families.

"Like many government bureaucracies, the Food and Drug Administration stifles innovation and creates unnecessary roadblocks that end up hurting the American people," said Garrett. "In this case, their short-sightedness has made a common treatment that millions of Americans rely on prohibitively expensive. The FDA has a job to protect Americans and ensure the food and drugs we use are safe, but they also need to make sure their actions don't hurt the very people they're trying to protect."

The letter, signed by a number of Members of Congress, asks the FDA to allow other companies to make alternatives to the EpiPen product by streamlining the FDA review process. Specifically, the letter asks:

If the FDA can clarify whether any barriers exist to the approval of safe alternative products to EpiPens.
How many alternatives to Mylan's EpiPen are currently being reviewed by the FDA
Where these alternatives are in the review process