Pfizer under the Spotlight of FDA


Pfizer is in trouble after it was accused by the Food and Drug administration of refusing to investigate complaints. The FDA said that it had received some disturbing information about the EpiPen manufacturer where they refused to look into complaints about their products. As a result, patients became severely ill, and a few lost their lives when the device failed to function. For starters, Pfizer specializes in the manufacture of a gadget known as EpiPen that is used to treat allergic reactions. The manufacturer produces the devices for a drug maker known as Mylan. This warning was brought to light through a letter that was written to a unit of Pfizer known as Meridian Medical Technologies. The letter that was issued on Tuesday notes that the company failed to investigate on a crucial component that is used by the device to ensure that it fires the right epinephrine dose. In the letter, the FDA makes it clear that the company refused to carry out a proper investigation despite receiving a number of complaints. The FDA noted that they had data that showed that the company received hundreds of complaints about the issue. As a result, the device failed to operate in what the FDA referred to as life threatening emergencies. This led to death in several cases.

Pfizer responded through Km Bencker who is the spokeswoman by saying that the company was very confident in the efficiency and safety of the products they produce. She further noted that the company had produced over 30 million EpiPens over the last three years. She said that the company had not received complaints about their product especially from people who are not medically trained. According to the company, they have no information related to the malfunctioning of their device and death of a user. As for Theresa Eisenman who is the FDA spokesman, she refused to offer information about the number of people who had died as a result. The letter written by the FDA showed that Mylan and Pfizer had recalled close to 13 lots of the products this year alone. This happened for products that had been sold in overseas markets as well as in the United States. However, this only happened after the FDA inspected the way these products were operating. Mylan also responded to the allegations through their spokeswoman. The company said that they are committed to safety and quality when it comes to their products.


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