Featured Company News - Pfizer Receives Warning Letter from FDA Highlighting Manufacturing Defects in the EpiPen Administered for Anaphylaxis
Research Desk Line-up: Alliqua BioMedical Post Earnings Coverage
LONDON, UK / ACCESSWIRE / September 11, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Pfizer Inc. (NYSE: PFE), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=PFE. The Company announced on September 08, 2017, that it received a warning letter from the US Food and Drug Administration (FDA) concerning the FDA's inspection of a Missouri manufacturing facility between February and March 2017. According to the warning letter, significant violations of current good manufacturing practices were observed. The manufacturing unit failed to thoroughly investigate multiple serious components and product failures, including the failures associated with patient deaths and severe illness. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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EpiPen
EpiPen, or the Epinephrine injection, is administered when a person has an allergic emergency, also known as anaphylaxis. Anaphylaxis occurs when the body perceives a trigger as a threat and starts forming antibodies to defend itself. These antibodies cause the release of certain molecules that indicate the immediate symptoms of the disease. Epinephrine, popularly known as "adrenaline," constricts the blood vessels to increase blood pressure, relaxes smooth muscles in the lungs to facilitate breathing, stimulates the heart, and works further to reduce the swelling that may occur around the face and lips.
The FDA Letter
The letter stated that, in February 2016, Meridian found that one unit of an EpiPen component that ensures the product delivers its dose of epinephrine did not work. The Company rejected the particular lot and another one, but later, continued to manufacture its products while the investigation continued through October 2016, according to the FDA letter. During the period, Meridian received hundreds of complaints where EpiPen failed to operate in emergencies, and where, in some situations, the error was fatal.
The letter also outlined the Company's failure to analyze sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Pfizer, in its defense, stated that between 2015 and now, it has shipped over 30 million EpiPen Auto-Injectors globally. According to the Company, it is not unusual to receive product complaints, especially when the EpiPen is administered by non-medically trained individuals. It further stated in an emailed statement that it currently has no information to indicate that there was any causal connection between these product complaints and any patient deaths.
The Mass Recall
The letter further stated that Pfizer did not thoroughly investigate the complaints, nor did it remove potentially defective products from the marketplace, even after it had identified a defect in one of the critical components used to manufacture the products and even after it had confirmed the same or similar component defect as the root cause of multiple complaints.
According to a May 2016 investigation into a customer complaint, a similar manufacturing defect was found from the February inspection, but the Company concluded that the defect was infrequent, and did not link the two issues to take market action. Of 172 complaint samples between 2014 and 2017 for products that did not activate correctly, Meridian disassembled and examined very few of them, according to the FDA.
Last Close Stock Review
On Friday, September 8, 2017, the stock closed the trading session at $34.10, marginally rising 0.32% from its previous closing price of $33.99. A total volume of 15.04 million shares have exchanged hands. Pfizer's stock price advanced 1.94% in the last one month and 4.06% in the past three months. Furthermore, since the start of the year, shares of the Company have gained 4.99%. The stock is trading at a PE ratio of 24.84 and has a dividend yield of 3.75%. The stock currently has a market cap of $203.17 billion.
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