FDA Warns Pfizer for Failing to Report Side Effects

The FDA sent a 12 page letter to Pfizer recently warning them that they have failed to comply with FDA regulations requiring them to report side effects for some of their drugs. The warning comes after an audit of it's New York headquarters last summer.

With some of their drug's Adverse Event Reports (AER), like Viagra, Pfizer was "misclassifying and/or downgrading" them to "non serious or without reasonable justification" in order to avoid having to file them within the 15 day deadline.

The data show that 9% of Adverse Event Reports were not filed on time between December 2008 and June 2009. 33% of Adverse Events were not filed one time for specific drugs, such as metformin, the letter also indicates. Even when Pfizer had been granted waivers by FDA for more time to file reports, which was the case for Bextra, Pfizer was still late in filing the AERs.

If you have been injured by one of Pfizer's drugs contact Rheingold, Giuffra, Ruffo & Plotkin LLP to speak with an attorney.
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