While anger is directed at Mylan Pharmaceuticals over the rising cost of its EpiPen device, some lawmakers wonder whether the US Food and Drug Administration should share some of the blame for the high prices paid by consumers. How so? They want to know if the agency made it possible for Mylan to dominate the market and charge whatever price it wants.
Specifically, five US senators wrote the FDA Thursday to express concerns the agency may have helped stifle competition. And in their letter to FDA Commissioner Dr. Robert Califf, the lawmakers worry the FDA is not doing enough to ensure that competitive versions are available, especially given that epinephrine — the main ingredient in EpiPen — has been on a drug shortage list since 2012.
The letter was sent by Senator Chuck Grassley (R-Iowa); Senator Amy Klobuchar (D-Minn.); Senator Richard Blumenthal (D-Conn.); Senator Patrick Leahy (D-Vt.); and Senator Ron Johnson (R-Wis.). An FDA spokeswoman wrote us that the agency is “reviewing the questions posed in the letter and will respond directly to the Congressional members.”
The issue is being raised largely in response to recent developments. Last year, Sanofi (SNY) withdrew a rival product called Auvi-Q, which was introduced in 2013, after 26 cases in which the device delivered an inaccurate dose. Earlier this year, the FDA rejected a generic EpiPen developed by Teva Pharmaceuticals and then required Adamis to expand studies for its own device.
The controversy over EpiPen erupted with the back-to-school season as many parents suddenly found the device cost more than ever before. The list price is $600, although insurance coverage varies. And while acute allergic attacks may not happen frequently, a stockpile is necessary. However, the EpiPen expires after a year, which means hoarding a lot of devices to avoid further price hikes is not an option.
“With the tripling of the number of people diagnosed with peanut allergies in the past 20 years, what steps has FDA taken to ensure that there is an adequate supply of self-injectable epinephrine?” the lawmakers wrote. “What steps, if any, has the FDA taken to ensure an efficient and safe approval process for competitive alternatives to the EpiPen is not hampered by backlogs?”
The senators also asked Califf to explain whether the FDA has explored whether an over-the-counter version of EpiPen could be made available.
The FDA Office of Generic Drugs, by the way, does have a policy to expedite reviews certain generic drug applications, and will move applications to the head of the line when a generic is not currently approved.
We should note there is one rival product available called Adrenaclick. But while not as expensive as EpiPen, Wall Street analysts say the product is not widely covered by insurers. And with nearly 90 percent market share, EpiPen is so ubiquitous that many people may not feel comfortable switching to an unfamiliar device when faced with a life-threatening situation.
This post was updated to reflect a comment from the FDA.