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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 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.

  • Perhaps these senators need to ask one of their own, Joe Manchin (WV-D), if he has had any “discussions” with FDA officials about Epipen competitors. After all, his daughter is the CEO of Mylan.

  • It’s not just Epi-pens, it’s a lot of name brand pharmaceuticals that have a long life of exclusivity in sales of a particular drug under a particular name during which the company can charge astronomically high prices. We’re all aware that the medications to treat AIDS cost very little to produce yet the prices are somehow jacked up 5000% in some places. The reasons given? Research and development. But 5000%??? Doesn’t this make the drug Daraprim too expensive for people in such poverty they couldn’t afford it? and in countries where 1 person in 8 has AIDS?
    Another area of this gouging is in veterinary medications. For example, the treatment of choice for Equine Protozoal Myeloencephalitis (EPM), a devastating neurological condition caused by ingestion of spores containing the protozoa responsible, is called Marquis, the brand name for ponazuril, the only medication out there with treatment success rates of up to 70%. The cost per month can be nearly $1000 per horse and they may need up to three months of treatment. When Bayer sold the rights to the drug to Merial, everyone thought there would be a drop in price and a generic form available. Guess again.
    While corporate greed can be blamed for a big part of this, we know when there are no alternatives, drug companies can and do charge anything they want for even life saving drugs and in the case of Epi-pen, it’s the squash on competitors that prevents generics from being more widely available. Thus the people getting their devices from Canada, some even going to Ebay.
    Big pharma has us all by the short hairs… we and our animals need certain medications, even cancer meds are extraordinarily high priced, and there is no ‘conscience’ really. Yes, Astra-Zeneca does offer to help offset prices by small percentages, but not nearly enough. When you look at the profit vs production costs, it simply can’t be justified in my opinion. Yes, just my opinion.

    • As a physician, I don’t get to hold patients up with a “like it or lump it” attitude. (nor would I) The ‘free market’ doesn’t apply to me, and I don’t get to say ,” That’s $1000 a visit or you can die….your choice.”
      So why does Big Pharma get to extort massive profits from the sick.
      Only in America. Disgraceful

  • You can’t make make chicken salad out of you know what. Don’t blame FDA. They have reviewed the submissions in a timely fashion and have twice issued Complete Response Letters to Adamis over major deficiencies in their regulatory submissions for approval of the epinephrine prefilled syringe (ePFS). Furthermore, because of the delays in approval of the ePFS Watson has pulled out of its deal to copromote the device. Thetefore even if the ePFS is approved soon Adamis will have to find a marketing partner to launch the ePFS into a market where Mylan has 85% market share. Good luck with that one.

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