FDA implicates Pfizer as EpiPen backfires, pharma firm ordered to investigate patient claims

The Food and Drug Administration has allegedly accused the pharma giant, Pfizer, of disregarding patient claims of EpiPen’s malfunctioning, despite repeated complaints being filed. If reports are to be believed, EpiPen’s supposed functionality failure has led to numerous patients suffering from a severe illness, and in some somber cases, which have come to the fore, a certain number of patients have even succumbed to death. Complaints filed against the drug categorically state that the anti-allergy device has failed to be operational during life-threatening emergencies.

For the uninitiated, Pfizer, one of the renowned names in the pharmaceutical industry, is reputed for manufacturing the EpiPen. The device is apparently designed to treat allergic reactions for the Pennsylvania headquartered specialty pharmaceuticals producer, Mylan. Back in 2010, Pfizer procured the EpiPen when it purchased King Pharmaceuticals, while Mylan officially held the exclusive marketing rights to the dispenser. Half a decade hence, Pfizer reported that the company had earned around USD 339 million via EpiPen sales. Whether the valuation could be totally credited to EpiPen or some other determinant is still unknown. Pfizer manufactures EpiPen through one of its subsidiaries, the Meridian Medical Technologies, while declaring that the terms of the device supply agreement are to be kept confidential.

Now, with the slew of complaints that have been filed in recent months, the FDA, has declared to legally charge the company of failing to conduct a systematic investigation. FDA’s accusatory latter states that the organization’s data alone depicts that the company indeed received hundreds of complaints regarding the misfiring of EpiPen in life-threatening situations. The latter also claims that Meridian Medical Technologies, EpiPen’s contract manufacturer has not satisfactorily scrutinized the most pivotal functionality of the device, which includes firing and delivering an adequate dose of epinephrine to eliminate an allergic reaction.

Pfizer has however, refuted FDA’s claims regarding EpiPen. One of the pharma giant’s spokespeople has categorically claimed that the company is rather confident as far as the efficiency and safety parameters of EpiPen’s site production is considered. Another fact that has been brought to light through this statement is that Pfizer has shipped more than 30 million EpiPens since 2015. The firm’s representatives have also affirmed that product complaints are certainly not uncommon, when the device is operated by medically untrained individuals.

Nonetheless, the FDA stands firm on its accusations regarding EpiPen. In the light of the grave scenario inclusive of patient complaints, FDA has ordered Pfizer to investigate the matter further and undertake the required remedial course of action ASAP. How much this indictment may affect the pharma giant’s reputation and product sales is difficult to decipher as of now. It remains to be seen if Pfizer gets to the root of the matter and settles the matter, while keeping the legal and ethical principles in mind.

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her belt, she has dabbled with website content writing, content auditing, tech w...

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