Pfizer Receives Stern Warning From FDA

Pfizer has received another warning from the FDA regarding significant violations surrounding operating practices. Companies are required to report any serious, adverse side effects reported by patients and/or doctors to the FDA within 15 days of receiving the information. The most recent twelve page warning letter stems from an inspection completed in July of 2009 that resulted in more than ten violations.

One issue that is cited in the warnings, is the failure of Pfizer to inform the FDA about reports of visual disturbances from users taking Viagra. Pfizer took it upon themselves to downgrade the reports to “non-serious without reasonable justification,” and virtually ignored. Reports of adverse side effects from the Pfizer drugs Lyrica and Lipitor were also uncovered during the inspection. The reports were not forwarded to the FDA until after the inspection took place.

In April, Pfizer received a letter outlining several significant violations associated with the trials of a pediatric antipsychotic drug, Geodon. The violations may result in the approval process for the drug being held up by the FDA. The letter sent to the Pfizer CEO included a situation about the company’s failure to report a drug sample theft and other missing drugs to the FDA.

Pfizer has responded to the recent warnings, and assures consumers they are working closely with the FDA in their reporting actions. Pfizer spokesperson Kristin Neese, also points out that the FDA warnings have nothing to do with the overall safety of any Pfizer drug. The company was issued similar warnings in 2004 and 2006.