FDA Warning to Pfizer over Failing to Report Side Effects
In a letter dated May 26, the FDA laid out serious warnings to pharmaceutical company Pfizer Inc. over its continued lack of action after patients reported problems with the company's drugs already on the market. Citing some of Pfizer's best known products such as Viagra, Lipitor and the seizure medicine Lyrica, the FDA warning stated the drug company had not properly documented or investigated reported problems with its approved medications.
According to a report by Reuters, the letter came from Ronald Pace, the director of the FDA's New York office. The letter said, "FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated." The patient reports "contained serious and unexpected adverse events... that were not submitted until they were identified during the FDA inspection," Pace wrote. Efforts to fix the problem "have been shown to be ineffective."
In the past, Reuters reports, the pharmaceutical company has said the problems in the lack of reporting were the fault of a new computer system and a failure to train the staff properly. Pfizer said it would improve training, update its user manuals and take additional steps. The FDA now says these actions were inadequate.
A specific example cited by the FDA regarding on-going reporting issues concerns one of Pfizer's best known drugs, Viagra. Viagra and similar medications are now known to cause serious visual problems, including blindness. However, Pfizer avoided reporting cases related to the drug within the FDA required 15-day deadline "by misclassifying and/or downgrading reports to non-serious without reasonable justification."
In a company statement, Pfizer said it would work with the FDA to satisfy the agency "and to assure optimal surveillance and reporting of post-marketing adverse events."
Reuters reports Director Pace's letter also stated that a failure to fix the problems identified by the agency could result in legal action without notice and the FDA might also delay action in approving the company's pending drugs, among other penalties.
- FDA warns Pfizer for not reporting side effects (Reuters)
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- Pfizer Hit with Largest Criminal Fine in US History (FindLaw's Blotter)
- Pharmaceutical Litigation (provided by Abraham, Watkins, Nichols, Sorrels, Agosto & Friend)