Slashdot Mirror
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.
They were lucky it was not from the UN. In that case it would have been a strongly worded letter.
And then we would have hundreds of undependable knockoffs on the market...
No, what we would have is several free market options based on competition, rather than what we have which is a monopoly. It is sad that we have an idiot like Donald Trump as president instead of a real Republican like Theodore Roosevelt who would have not stood for this crap or the type of bullshit that piss ant Martin Shkreli tried to pull.
How far we have fallen as a society in just 100 years! I blame the educational system decline and corporate America getting out of control and having it's tendrils firmly embedded in the government.. Lobbying should be outlawed because of shit like this. We would need a constitutional Amendment to make it happen, but it will never happen because too many dollars are changing hands this way for too long.
Capitalism: bread waits for people. Socialism: people wait for bread.
And then you have the American system. Corporations using the government to bully the people into buying overpriced bread that nobody really wants. ;-)
This is very one-sided. In Pfizer's defense they have released a statement that they have always put profits, err patients, first. You can't expect them to spend a huge amount of money on a small product. They only sell about 1,000,000 of these per year, and the $200M profit barely covers their executive bonuses.