Pfizer In Trouble Again, for Not Reporting Side Effects
Pfizer is in trouble again as the FDA has given written warning over the company’s failure to report serious and unexpected potential side effects from some of its drugs in a timely fashion.
The warning letter is the second issued by the FDA. In April, Pfizer was warned about "significant violations" involving pediatric trials of its antipsychotic drug Geodon.
In a 12-page letter addressed to Pfizer chief executive Jeffrey Kindler, the FDA stated that delays in reporting side effects date back from 2004 and have increased since then. The treatments cited in the letter include the cholesterol-lowering blockbuster Lipitor (atorvastatin) and the erectile dysfunction drug Viagra (sildenafil).
Ronald Pace, director of the FDA's New York office, told Pfizer in the letter dated May 26 that it had not properly documented or investigated reported problems in patients after the drugs were approved for use. "FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated," stated Pace.
There was a 6-week inspection of Pfizer's New York headquarters conducted by FDA in July and August of last year. It was reported that there where “system-wide lapses” by the world's largest drug maker. Pace added that the report of the patients contained serious and unexpected adverse events and no efforts were made towards fixing the problem.
According to the FDA, the company's delays in telling the agency about reported complaints have only grown. In fact, over 4 percent of Pfizer's 80,560 reports were sent late from March 2006 through December 2008 compared with 9 percent from December 2008 to June 2009.
Pace gave strong warning that he wrote in the letter to Pfizer that failure to fix the problems could result in legal action without notice and the FDA could delay action in approving the company's pending drugs, among other penalties.
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