The FDA has blasted EpiPen manufacturers for doing nothing while users died or developed serious illnesses after using faulty products.
In a letter published this week, the agency said these deaths would have been preventable had the makers of EpiPen tested their products, or at least investigated malfunctioning reports more thoroughly.
Tens of thousands of EpiPens were recalled in March after reports from earlier this year saying the allergy-shot devices failed to work during emergencies.
It is the latest scandal for EpiPen distributor Mylan, which is known for raising the price of the life-saving devices more than 400 percent in just a few years.
Pfizer, which owns Mylan, has responded to the FDA’s accusations, saying that there is no evidence that their devices led to patient deaths.
EpiPens are used by people with severe allergies who inject themselves with the drug epinephrine during life-threatening allergy attacks.
When a person who has a severe reaction to a certain food, drug or other allergen comes into contact with it, they can shoot epinephrine into their thigh, which will temporarily offset the symptoms of their attack until they can get to a hospital.
Millions of Americans rely on EpiPens, which they carry with them at all times in case they undergo an attack.
EpiPens are made by Meridian Medical Technologies, which is owned by Pfizer.
The products are sold by a company called Mylan NV, which sparked outrage last year when it hiked the price of EpiPens up to $608 for a two pack of the devices.
This pricing was up 500 percent from the cost of a two pack ten years ago.
The company’s CEO defended the price increase, saying that Mylan was barely making a profit.
And this week, the FDA blamed Pfizer for not keeping its Brentwood, Missouri, manufacturing facility up to code in a warning letter to the company issued earlier this week.
‘You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illnesses,’ the FDA said.
One example of the pharmaceutical company’s failures was its choice not to investigate a batch of EpiPen products, even though it had discovered that one included in the batch would not properly fire and deliver the correct dose of epinephrine to its user.
Instead of testing the entire case of EpiPens in which the faulty one was found, the company only threw out the faulty one and one other from the lot.
‘You did not examine any units from the associated lot to determine whether additional units were affected by the same or similar manufacturing defects,’ the FDA explained.
And as a result, EpiPen users complained to Pfizer that their devices failed or were difficult to activate.
Pfizer was aware of these complaints but did nothing to address them, according to the letter.
‘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 warning said.
Pfizer responded to the FDA’s allegations, saying that they are confident their products are safe.
The company also said that the chance that an EpiPen is used incorrectly is great since most people who use them – to inject themselves – are not doctors.
Pfizer said: ‘Between 2015 and now we have shipped more than 30 million EpiPen Auto-Injectors globally. It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals.
‘We currently have no information to indicate that there was any causal connection between these product complaints and any patient deaths’
The company added that they do not anticipate any supply issues as a result of the FDA’s warning letter.