FDA cites Pfizer for delaying side effect warnings

Pfizer (NYSE: PFE) is in trouble today with the announcement that the FDA has sent it warning letter citing the pharma giant for dragging its heels on reporting side effects associated with several currently marketed drugs. 

In a scathing, 12-page letter, the agency says Pfizer has sat on side effect data going back as far as 2004 on several of products, including Viagra, Lipitor and Lyrica. It also scolds the company for neglecting to tell the agency about missing samples, some of which may have been stolen. The May 26 warning was issued in response to a six-week audit of Pfizer's New York headquarters last summer, Pharmalot reports.

In one instance, Pfizer failed to report cases of visual problems within the required deadline that might have been related to Viagra "by misclassifying and/or downgrading reports to non-serious without reasonable justification," the agency says. Pfizer faces litigation over Viagra and visual side effects, as Pharmalot notes.

The agency requested an immediate meeting and asked for the problems to be fixed within 15 days, or an explanation provided if it would take longer, Reuters reports. Pfizer also must submit a revised plan to fix the problems.

The drugmaker has issued a statment in its defense, saying it provides "complete and accurate data" to determine the benefits and risks of its drugs, although that's not the same thing as saying all adverse events are reported on time. The drugmaker then promised to " assure optimal surveillance and reporting of post-marketing adverse events...We are committed to full compliance and timely and accurate submission of individual adverse event reports." 

- read this Reuters item
- see Pharmalot's take

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