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.

Comments

A warning letter

[willoughby]

Yeah, that'll teach 'em.

Re:A warning letter

[arbiter1]

Opens the door for massive lawsuit by families that were effected. In the end if it happen, be very expensive

Re:A warning letter

[Anonymous Coward]

They were lucky it was not from the UN. In that case it would have been a strongly worded letter.

Re:A warning letter

[wickerprints]

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.

Re:A warning letter

[Rockoon]

This.

The FDA caused the problem to begin with by changing the standards and requiring all delivery systems to be re-certified. Most of the alternatives were phased out because re-certification is too expensive.

One can argue that Mylan caused the problem by lobbying the FDA to change the standards as it knew that its competitors couldnt afford to re-certify, but it was the FDA that held the power to do it or not do it, and they went ahead and did it.

The FDA was good up until the thalidomide incident. Thalidomide was causing birth defects all across Europe but not in America because Europe only required Efficacy standards while America only required Safety standards. The one thing Thalidomide had going for it was Efficacy (the stuff worked as advertised.) After the thalidomide fiasco, the FDA took the European scandal opportunity to increase the scope of its power and influence by petitioned congress to add Efficacy testing. It made no sense but the reasons for expanding government power rarely does.

So now getting anything passed the FDA is insanely expensive, so expensive that real life saving drugs and devices never see the light of day. So now any change to standards for particular devices or drugs regardless of for Safety or Efficacy always removes players from the market purely for financial reasons. Every time, just like this time.

Fuck the FDA.

Re: A warning letter

[Anonymous Coward]

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.

Re:A warning letter

[hawguy]

After the thalidomide fiasco, the FDA took the European scandal opportunity to increase the scope of its power and influence by petitioned congress to add Efficacy testing. It made no sense but the reasons for expanding government power rarely does.

Isn't it easier to prove efficacy than to prove safety?

To prove that something works you just have to show that people had an improvement in the condition being treated. You don't need to follow up every side effect and see if it was caused by your drug.

In any case, why is efficacy testing a bad thing? Shouldn't a drug be proven to actually treat the condition it's supposed to be treating?

The cost to bring a drug to market is excessive, but that doesn't mean that drugs should be sold without any proof that they work.

Thorough Investigation

[ThisIsNotAName]

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.

Re:Thorough Investigation

[ThisIsNotAName]

I intended to end that with a </s>.
*sigh*

Invalidate their patents, dismantle both companies

[Anonymous Coward]

This is really simple.

Both companies should be ban hammered into the oblivion for public defrauding and endangerment. Make a good fucking example of 'em so the others fall in line.

Oh, what am I saying- these companies own the American government. The only thing the FDA can do is send nasty letters. The moment they consider doing anything serious, money will be exchanged behind the scenes, and the whole thing will go away quietly.

Nice country ya'll got there. At least you got your freedom though, right? Freedom to pay exorbitant prices for life saving medication and freedom to die when that medication fails to work.

Slam bam thank you ma'am.

[fustakrakich]

Yeah, that'll teach 'em.

Well sure, if it's a firmly worded letter.

This is all bullshit. Unless their patents and copyrights and corporate charter are revoked, it's just silly nonsense that will make no difference. There's no point in getting worked up over it.

Let's see a negligient homicide charge!

[chromaexcursion]

How to shake up the barrel!

Re:Let's see a negligient homicide charge!

[drew_kime]

Exactly. Elements of involuntary manslaughter (AKA negligent homicide):

1. Someone was killed as a result of the defendant's actions.
2. The act either was inherently dangerous to others or done with reckless disregard for human life.
3. The defendant knew or should have known his or her conduct was a threat to the lives of others.

Re:NOTHING IS EVER GOING TO HAPPEN TO THAT COMPANY

[PopeRatzo]

The CEO is the daughter of a democrat senator.

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.

Re:I am shocked - Shocked!

[fuzzyfuzzyfungus]

It's not as though this is a surprise or anything; but it's a pitiful follow-up to their, um, 'optimistic' pricing practices.

The whole selling point of their product is reliable delivery even by an unskilled user under duress. The epinephrine is a cheap generic; the autoinjector is $600 of mechanism wrapped around it.

For that kind of money you deserve excellence; and they don't even appear to be delivering enough to avoid credible charges of negligence. That's just pitiful.

Re:I am shocked - Shocked!

[Anonymous Coward]

And then we would have hundreds of undependable knockoffs on the market...

The Netherlands had a recall

[Skinkie]

In The Netherlands there was a recall for two bad EpiPen batches last year. Hence I wonder why the same isn't done in the USA. But for better reasons I switched manufacturer: If you compare EpiPen, Jext and Emerade, you will find that the needle length of Emerade is significantly longer. Therefore penetrating the skin deeper and overcome first world problem: fat. The drug is then delivered in the muscle, where it is supposed to be. Next to that, the operation of the Emerade is more successful without advanced patient instruction and practice.

Re:I am shocked - Shocked!

[Anonymous Coward]

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.

Re:I am shocked - Shocked!

[DNS-and-BIND]

You are correct to point out the many problems with capitalism . Dealing with an excess of plenty is a challenge, and it will be a challenge going into the future. Under socialism, there wouldn't be any products at all.

Capitalism: bread waits for people. Socialism: people wait for bread.

Re:I am shocked - Shocked!

[aix tom]

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. ;-)

Re:NOTHING IS EVER GOING TO HAPPEN TO THAT COMPANY

[Hognoxious]

I bet his family name was originally along the lines of McIninch, because he certainly seems like a true Scotsman.

Re:Misplaced ire

[Khyber]

"NOBODY died on account of this product"

There are dozens of reported cases where the pen failed to deliver or trigger and the person died as a result, both in the USA and EU. Only the EU forced a recall of the faulty injectors. Perhaps you should actually look into these cases before spouting off about that which you know nothing of.

Re:Counterpoint

[sjames]

Nonsense. They are perfectly free to recall bad batches that were clearly NOT made to the specs and standards that have been approved and replace those units with some that have.

The letter states that they failed to do that.