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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.
I'm sure that with the Mylan CEO being the daughter of a U.S. senator, there will be a thorough investigation of all of this.
A democratic senator who is a reliable vote for the Republicans. Joe Manchin is the scum of the earth. Being a Democrat in West Virginia means you're a Republican, as we've seen with the sitting governor deciding to formally switch to the GOP.
There are no recall elections in West Virginia for statewide or federal office-holders.
You are welcome on my lawn.
An FDA warning letter is not simply a sternly worded "please stop" message or a slap on the wrist. The phrase "warning letter" suggests a much more benign action than is actually the case.
The purpose of these letters is is to document in clear terms (1) the scope of noncompliance, (2) whether any previous responses to the Agency were received, reviewed, and found adequate, and (3) any specific corrective and preventive actions the Agency expects the firm to complete and the timeframe in which such actions are to be completed. Failure to do so may result in further legal action without notice. So, a warning letter is basically the "last chance before we shut you down" communication. As a public document, it is also a notification to the public that there is an issue with a product. It's a necessary part of the legal paperwork FDA creates to justify enforcement action.
Usually, a company works with the Agency to negotiate a path forward to compliance. But if the violation is severe enough, FDA can and does act unilaterally. But you also have to remember that we are talking about a grossly underfunded government agency that has to oversee the safety of not only drugs, but medical devices, cosmetics, and the entire nation's food supply. (Seafood, for example, is a big one.) Frankly, it is amazing that they are able to do what they can with the paltry funding they get from a business-friendly Congress that largely views the Agency as bureaucratic red tape and an impediment to developing cutting edge medicines. Some people would have us do away with any regulation entirely and return to the days of thalidomide and arsenic and snake oil salesmen.
So if you want to put the blame on anyone here, blame the manufacturer for claiming to follow GMP but not actually spending the money to do it. Blame Wall Street for lobbying for lax regulation. Blame a Republican Congress that uses small government as an excuse to jeopardize public health and safety because their Big Business buddies aren't making enough profits.
The bottom line is that FDA doesn't have enough regulatory power, doesn't have the manpower, and doesn't have the money to investigate every single company's products and practices that fall in their scope. They largely rely on the industry to be honest with them and with the public. They also rely on patients to report ADRs or product failures, as was the case here with EpiPen. If there is an area where I feel the FDA is especially failing consumers, it is with the overuse of opioids. Too little is being done and the patient risk/benefit profile clearly does not justify the way these drugs are being marketed and prescribed.
It is sad that people continue to be harmed and die because of the willful negligence of profiteering corporations, but that's hardly a new story.