What’s Behind The Persistent Shortage Of Lifesaving EpiPens

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Mylan's EpiPen allergy shots are photographed in Princeton, Ill., on Aug. 26, 2016. MUST CRDIT: Bloomberg photo by Daniel Acker
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Mylan and Pfizer are still struggling with manufacturing issues for the EpiPen anti-allergy injector as the critical back-to-school season gets underway and a rival generic product hits the market.

EpiPens, which can help stop a severe or life-threatening allergic reaction, have been hard to get since at least May 2018, when the U.S. Food and Drug Administration said the device was in short supply. Former and current employees of Pfizer’s Meridian Medical Technologies Inc., which makes the product for Mylan, said supply has been unsteady since at least 2017, when inspectors began noticing defects.

Pfizer spokeswoman Amy Rose said the drugmaker is committed to resolving the supply problem.

“Our production output is improving,” Rose said. “However, we anticipate supply to be tight as we enter the peak demand season.”

Consumers have been forced to adjust to the shortage. While other options are available, patients switching to other devices face uneven distribution, the reluctance of insurers to pay for similar treatments and uneasiness with unfamiliar products.

Teva Pharmaceutical Industries Ltd., which already makes a generic EpiPen, began selling a copycat version of Mylan’s EpiPen Jr. for small children on Aug. 20.

“We will continue working to ensure availability of both strengths in the U.S. and plan to accelerate production to meet the urgent need for this medicine,” said Brendan O’Grady, Teva’s executive vice president and head of North American commercial, in a statement.

Each year in the U.S., 200,000 people require emergency medical care for allergic reactions to food, according to Food Allergy Research & Education, an advocacy group. More than 40% of children with food allergies have experienced a severe reaction such as anaphylaxis, the group said.

The EpiPen shortage can be traced at least in part to two factories in Missouri. The Mylan EpiPen, EpiPen Jr. and its generics are all manufactured in plants near St. Louis. The devices are produced at a plant in Brentwood and inspected at a facility in Westport.

The three-step inspection process begins with the devices being scanned by a machine for defects. The EpiPens then move along a conveyor belt while inspectors look at the devices under magnification. Lastly, the inspectors hold a handful of units to look for deficiencies.

A former employee, who left the company about two years ago, said workers were expected to successfully inspect about 4,000 EpiPens a day in 2016. About every day-and-a-half, the employee said, the plant was able to put out a new batch of EpiPens — as many as 90,000 devices.

But that changed in 2017 when inspectors began noticing chips in the glass cartridges of the devices, the inspector said. Other issues followed, the employee said, such as bent or broken needles.

An FDA warning letter was sent to Meridian in September 2017 that “summarizes significant violations of good manufacturing practice” found in inspections from Feb. 20 to March 24, 2017.

EpiPens, which contain the hormone epinephrine (also known as adrenaline), are used to stave off allergic reactions that can in some cases kill. Complaints of EpiPen failures skyrocketed between 2016 and 2017 and included deaths allegedly linked to device malfunctions.

After a series of changes to the process, the former employee said supply dropped to one new batch of EpiPens about every two to three days, and a current employee interviewed by Bloomberg said problems continue to plague the plant.

Rose, the Pfizer spokeswoman, declined to comment on the manufacturing process, saying the company’s production rates are proprietary.

A current inspector, who also requested anonymity, said batches of EpiPens have failed to eject and that entire lots of the devices were dumped in the trash.

At the end of November 2018, a little over a year after the FDA warning letter was issued, the Brentwood manufacturing plant was shut down for its typical two-week maintenance period.

While inspectors routinely have a backlog of work to do, the employee said, they ran out of product to inspect by the second week of December. The next week, supervisors indefinitely laid off all inspectors.

Meridian, meanwhile, is working to improve the conditions. The current inspector was brought back earlier this year, and there are now about 20 to 30 inspectors per shift. The inspector has trained at least five employees since being hired by Meridian.

“Further increasing our hiring and training of the specialized workforce at Meridian has been a priority of ours over the past couple of years,” said Rose.

Rose said output has improved recently, and added that Mylan’s customer-service team has been able to help locate EpiPens for patients.

Last month, Pfizer said it would combine its Upjohn unit, which sells older blockbuster medicines like Lipitor, with Mylan to create a new publicly traded company. Meridian isn’t currently part of Upjohn, but Mylan and Pfizer are discussing a transfer of the business to the new company, Rose said.

A representative for Mylan didn’t respond to requests for comment.

In the meantime, other companies like Teva are stepping up to the plate. In the company’s Aug. 7 earnings call, Chief Executive Officer Kare Schultz said because of Teva’s product line, “no one should be short on EpiPen this fall.”

“They’re coming in with big supply,” said Evercore ISI analyst Umer Raffat. “They wouldn’t just use the words ‘back to school’ if they weren’t prepared.”

(c) 2019, Bloomberg · Myah Ward  

{Matzav.com}

19 COMMENTS

  1. If, according to the CDC, allergic reactions is a side effect from vaccination that kills the immune system, wouldn’t it make sense to stop these fatal injections?

  2. So we have big Pharmaceutical companies lying once again. And these criminals are being supported by the dumb stupid taxpayers. The taxpayers are like sheep going to slaughter. They never make a peep. If a 20 year old congressperson says we have to pay, we pay. They know what’s best for us and where it’s best to steal our hard earned money. The American taxpayers are some of the dumbest people to walk the face of the earth.

  3. Here’s a link to a study explaining how vaccines create allergies.
    http://www.omicsgroup.org/journals/evidence-that-food-proteins-in-vaccines-cause-the-development-of-foodallergies-and-its-implications-for-vaccine-policy-2329-6631-1000137.pdf

    While many people think that vaccines are just a part of the virus in something like saline, that is far from the truth. Vaccines are a concoction of biologically active components, chemicals, and other materials including food proteins and it’s long been known that injected proteins can cause allergies.

  4. People are born with allergies, how can they be caused by vaccines if you get allergies before you’re ever vaccinated? That makes no sense!

    • People might be born with allergies but contracting the actual measles strengthens the immune system which fight allergies (and other diseases). In one of Rav Avrohom Mordechai Malach’s talks he mentioned a story of a child who refused to get the shot while all his siblings were vaccinated. This child was allergic to almost everything. One Shabbos they had a guest who – they later discovered – had measles and they were very concerned about their young son/brother who wasn’t vaccinated. Sure enough this child contracted the measles. The family went hysterical and were worried. But then, the father related, after his case of measles they noticed all his allergies gone!!! Don’t believe? Confirm it with Rav Malach.

      By the way, those born with allergies are because their mothers were vaccinated rather than having gotten the actual measles.

  5. MM – seems like you’re another one who prefers the illusionary coziness of being in the dark about vaccines. You won’t think it’s so “kooky” to reject vaccines when you turn on the light & READ the truth – the product inserts of corrupt pHARMa tellit like it is! The ONLY thing that vaccines prevent is excellent health! Wake up please – if you’re not part of the solution – you’re part of the problem!

    • You probably didn’t become “allergic” where you almost can’t breath when you smell it, but you became lactose intolerant with bloating, gas, stomach ache, etc.

  6. No…. I cant breathe , my lips and tongue swell and become numb, and I get very itchy.
    By the way, I vaccinate and I plan on faxing my kids. I’m just saying…..

  7. That’s the “Kookiest” thing I’ve heard so far!

    Check your facts. Measles doesn’t cure anything, especially from the maladies that plague your common sense!

    Sure, the world is flat, Elvis is still alive, men never landed on the moon, and the Big Pharma controls all the world’s Governments.

    GET A LIFE MAN!

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