WASHINGTON (AP) – Federal regulators have warned Pfizer Inc. for failing to promptly report complaints with its drugs that may have involved serious injury.
In a warning letter obtained by The Associated Press, the Food and Drug Administration cites a number of product complaints which were not reported to government regulators within the required 15 days.
In some cases, Pfizer failed to report the adverse events all together, including reports of serious side effects with the cholesterol drug Lipitor and the antiseizure drug Lyrica.
FDA inspectors found the unreported complaints during a routine inspection at the company’s New York headquarters last summer. The problems outlined in the May 26 warning letter are not new. Inspectors cited the company for similar violations in 2004 and 2006.
Pfizer previously told regulators it would revamp its file tracking system and retrain employees, but the FDA states that those efforts “have been shown to be ineffective.”
Between March 2006 and July 2009 about 13 percent of the Pfizer’s adverse-event reports were submitted late, according to the FDA.
In one case, Pfizer repeatedly failed to meet the FDA’s deadline for reporting vision problems with Viagra, the blockbuster erectile dysfunction drug. Pfizer staffers classified seven such complaints as “non-serious,” even though Viagra has been associated with sudden vision loss.
Pfizer responded to the FDA’s citations in September, saying it has reduced late submissions since updating its computer systems in May 2009. But the FDA says that the company has not provided metrics to support that claim.
The warning letter demands that Pfizer submit a plan for correcting the problems within 15 business days.
Pfizer said in a statement it would work with the FDA to address the issues cited in the 12-page letter.
“We are committed to full compliance and timely and accurate submission of individual adverse-event reports,” states the company.
The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing, marketing and testing. The letters are not legally binding, but the agency can take companies to court if they are ignored.
Date: June 9, 2010
Source: Associated Press
Filed Under: Drug Discovery