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FDA: Warning letter to Pfizer re EpiPen cites laxity

As revealed in a recent Bloomberg article, there is a stark difference of opinion between health regulators at the U.S Food and Drug Administration and Pfizer, a global pharmaceutical company, regarding one of the latter's product offerings.

Namely, that is EpiPen, an automatic-injecting product that patients use when heightened allergy symptoms suddenly turn threatening.

According to hundreds of complaints received by patients, the pens haven't work when needed, instead proving to be defective in material ways. Reported problems with EpiPens have included the following:

  • Allegations that the drug in certain pens leaked out prior to use, leaving no medication left to administer during a time of need; and
  • Complaints of injectors simply not working

Reportedly, some patients have died from product glitches.

Pfizer representatives pointedly downplay the charges, with one official company statement stressing that most patients using EpiPens are not medically trained and might simply be using the product incorrectly.

The company states that it lacks any information "to indicate that there was any causal connection between these product complaints and any patient deaths."

The FDA is decidedly not on board with that corporate reaction. The agency recently issued a warning letter to the Pfizer unit that makes and distributes EpiPens, stating that it "failed to thoroughly investigate multiple serious component and product failures" that have been reported.

Among other things, the FDA points to Pfizer's alleged laxity in following through on complaints and its failure to remove claimed problem products from the market stream after being on notice that they could be threatening the public's health.

Regulators are demanding that Pfizer take corrective actions immediately.

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