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FDA Slams EpiPen Maker For Doing Nothing While Hundreds Failed, People Died (arstechnica.com)
An anonymous reader quotes a report from Ars Technica: The manufacturer of EpiPen devices failed to address known malfunctions in its epinephrine auto-injectors even as hundreds of customer complaints rolled in and failures were linked to deaths, according to the Food and Drug Administration. The damning allegations came to light today when the FDA posted a warning letter it sent September 5 to the manufacturer, Meridian Medical Technologies, Inc. The company (which is owned by Pfizer) produces EpiPens for Mylan, which owns the devices and is notorious for dramatically raising prices by more than 400 percent in recent years. The auto-injectors are designed to be used during life-threatening allergic reactions to provide a quick shot of epinephrine. If they fail to fire, people experiencing a reaction can die or suffer serious illnesses. According to the FDA, that's exactly what happened for hundreds of customers. In the letter, the agency wrote: "In fact, your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died."
The agency goes on to lambast Meridian Medical for failing to investigate problems with the devices, recall bad batches, and follow-up on problems found. For instance, a customer made a complaint in April 2016 that an EpiPen failed. When Meridian disassembled the device, it found a deformed component that led to the problem -- the exact same defect it had found in February when another unit failed.
The agency goes on to lambast Meridian Medical for failing to investigate problems with the devices, recall bad batches, and follow-up on problems found. For instance, a customer made a complaint in April 2016 that an EpiPen failed. When Meridian disassembled the device, it found a deformed component that led to the problem -- the exact same defect it had found in February when another unit failed.
How to shake up the barrel!
This is a perfect example of the failure of government regulation in health care. If this had been a purely capitalistic system (not that I'm advocating pure capitalism for health care), anyone could manufacture an epi-pen type device. Once word got out that Mylan's product was failing and they weren't doing anything to fix the defect, people would stop buying them and switch to a competitor's product which was reported to be reliable on the net. Mylan's reputation would be tarnished as producing unreliable health products, and they possibly could have gone bankrupt as people stopped buying their other products as well based on their poor reputation.
The reason there's no competition and Mylan sells the only epi-pen on the market is because FDA regulations have made it prohibitively expensive for a competitor to introduce an alternative into the market. Since it's the FDA's fault there's only one product on the market, the onus is on the FDA to make sure it is reliable and effective. They failed to do that in a timely manner.