Pfizer Cited by FDA for Not Reporting Drug Side Effects

Drug giant Pfizer has just been warned by the U.S. Food and Drug Administration (FDA) for not reporting some significant and unexpected possible side effects from some of its available medications, said Reuters. The warning letter, 12 pages in length, was sent to Jeffrey Kindler, Pfizer’s Chief Executive, added Reuters.

The FDA not only highlighted a variety of examples in which some of the firm’s most popular brand drugs—Viagra, an impotence medication; Lipitor, its cholesterol drug; and its seizure medication, <"">Lyrica—were involved, but it also cited delays in reporting of side effects going back to 2004 and that these delays have increased, reported Reuters, from four to nine percent since 2006. Pfizer was also cited for delays in advising the agency about thefts and noteworthy losses of its medications, said Reuters.

We recently wrote that a study revealed a link between Viagra and long-term hearing loss. Lipitor was the subject of a Congressional probe over how Pfizer was marketing the drug in television ads, and Lyrica was one of the drugs cited when Dr. Scott S. Reuben, former chief of acute pain at the Bay State Hospital in Springfield, Massachusetts, pleaded guilty to one count of health care fraud. The plea came after Dr. Reuben was charged in federal court with falsifying studies involving the post-surgical benefits of a variety of drugs, including Lyrica, by fabricating patient data for studies he submitted to, and that were ultimately published in, medical journals.

Concerning the current FDA letter, written by Ronald Pace, director of the FDA’s New York office and dated May 26, Pfizer was faulted for neither appropriately documenting nor investigating reports of problems in patients following drug approval, said Reuters. “FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated,” Pace wrote, quoted Reuters.

In his letter, Pace is seeking an immediate meeting between the FDA and Pfizer to discuss the violations; that the problems be resolved within 15 days—or an explanation if Pfizer needs an extension; and for submission of a revised plan, said Reuters. Pfizer confirmed the letter was received June 3.

The letter followed a six-week review into Pfizer’s New York headquarters last July and August in which the agency discovered what Reuters described as “system-wide lapses at the world’s largest drugmaker.” Reports from patients, said Pace, “contained serious and unexpected adverse events … that were not submitted until they were identified during the FDA inspection,” steps to correct the situation “have been shown to be ineffective,” he added, quoted Reuters.

Also, while Viagra and medications like it are known to lead to serious visual events, such as blindness, Pfizer never reported such cases within the agency mandated 15-day time frame, “by misclassifying and/or downgrading reports to non-serious without reasonable justification,” said the report. Regarding the drugmaker’s now withdrawn Bextra, a painkiller, Pfizer received a 60-day waiver to forward complaints, said Reuters; however, Pfizer missed even this larger window. According to the FDA, the drugmaker, at first, said problems were due to a then-new computerized reporting system and that staff had not received adequate training. In response to the FDA, Pfizer, in September of 2009, said it planned on enhancing training manuals, improving staff training, and other steps, said Reuters. Still, the FDA said it found Pfizer’s steps “inadequate,” reported Reuters. And, although Pfizer told the FDA it improved its reporting some time after May 2009, it did not provide information to confirm those improvements,
said the FDA and did not supply proof that it trained its employees, Reuters reported.

If Pfizer does not respond to the FDA’s request, the agency could take legal action with no notice, delay pending drug approvals, and issue penalties, said Pace.

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