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FDA, pharmaceutical company at odds over well-known allergy shot

Daniels, Porco & Lusardi, LLP, is a New York health care law firm that traces its roots back decades and has collective on-point experience over relevant client matters that spans well more than a century. As such, the firm's attorneys candidly know a thing or two about the close regulatory scrutiny that health care-related businesses routinely face.

It is, in a word, exacting.

Industry participants ranging widely from hospital administrators, individual doctors/physician groups and nurses to medical device makers, pharmacists, surgical center principals and more are regularly challenged by -- as we note on our website -- "layers of regulatory and compliance issues that must be faced."

A recent article in the national press serves as a reminder that pharmaceutical companies, too, face stiff regulatory oversight and compliance hurdles, on a daily basis.

That media piece casts a spotlight on Pfizer, specifically its subsidiary that makes EpiPens, patient-carried self-injecting shots that can quickly alleviate dangerous allergy symptoms.

A spate of consumer complaints regarding that product now has Pfizer executives squarely in the crosshairs of FDA regulators, who contend -- via a recently issued warning letter -- that the company hasn't been duly responsive to allegations of defective injectors and inadvertently leaking pens.

The FDA is demanding immediate corrective action from the global drug company.

In response, Pfizer has underscored the commonality of consumer complaints relating to the administration of injectable drugs "by non-medically trained individuals." The company says it lacks any data that would reasonably indicate "any causal connection" between the reported complaints and cited patient harms.

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