The plaintiffs' claims are premised on the assertion that the ads imply that Celebrex is superior to other NSAIDs because it has fewer GI symptoms, a claim which the FDA expressly determined would be false and misleading.
Pfizer argues that particular ads identified in the complaint are consistent with the FDA-required label and therefore any claims based on those ads are preempted.
Pfizer is actually arguing, the judge said, that certain ads were not misleading as a matter of law, that the ads do not imply GI superiority or greater efficacy than other NSAIDs.
The court said it declined to make such a determination on the limited record and briefing currently before the Court.
Pfizer also argued that the FDA should initially decide whether the ads are misleading because plaintiffs' claims fall within the "primary jurisdiction" of the FDA.
The court determined that the false advertising claims do not implicate the primary jurisdiction doctrine. "The issue is not whether Celebrex has fewer GI complications than other over-counter NSAIDs;" the court stated, "the FDA has already determined that it does not."
"The issue," it explained, "is whether contrary to the FDA's findings, Pfizer nonetheless falsely claimed that Celebrex was superior."
Courts and juries frequently decide similar false advertising claims, the court noted.
In its conclusion, the court stated that, "Pfizer has not established that the FDA has determined that all of Pfizer's promotional material strikes a "fair balance" and are not false and misleading."
"Accordingly," the court ruled, "Pfizer's motion to dismiss the false advertising claims on conflict preemption grounds is denied."
There is certainly ample evidence to present to a jury to back up the claims that the Celebrex makers engaged in false advertising and over-promotion of Celebrex, within the walls of the various FDA offices alone.
First off, Pfizer's claim that Celebrex ads were preapproved by the FDA is dead in the water. On December 1, 2005, Tom Abrams, director of the DDMAC, said in an interview for Pharmaceutical Executive that although FDA regulations require companies to submit advertising material at the time of first use, his office receives an average of 53,000 promotional items a year and his staff of 35 cannot handle that volume of screening.
"DDMAC has limited resources and we use our limited resources as effectively as we can to do our job," he said.
In fact, Mr Abrams says the biggest misconception is that the FDA approves all ads before they are released, and most ads are launched without the agency reviewing them. In fact he states, "Often, we're seeing it at the same time as the American public."
According to Mr Abrams, when the FDA determines that an ad violates regulations, the agency sends the company either a notice of violation letter or a warning letter. Notice letters are issued for the least serious offenses and warning letters are issued for serious or repetitive violations and request that the company stop the promotion, and disseminate corrective messages.
FDA records show that Celebrex received seven citations for false or misleading promotions between 1997 and 2005. In 1997, before Celebrex even obtained FDA approval, the FDA accused Celebrex maker at the time, GD Searle, of touting the drug on the internet as "a breakthrough in arthritis therapy,'' and suggesting that it caused no gastrointestinal bleeding.
Pfizer argues that particular ads identified in the complaint are consistent with the FDA-required label and therefore any claims based on those ads are preempted.
Pfizer is actually arguing, the judge said, that certain ads were not misleading as a matter of law, that the ads do not imply GI superiority or greater efficacy than other NSAIDs.
The court said it declined to make such a determination on the limited record and briefing currently before the Court.
The court determined that the false advertising claims do not implicate the primary jurisdiction doctrine. "The issue is not whether Celebrex has fewer GI complications than other over-counter NSAIDs;" the court stated, "the FDA has already determined that it does not."
"The issue," it explained, "is whether contrary to the FDA's findings, Pfizer nonetheless falsely claimed that Celebrex was superior."
Courts and juries frequently decide similar false advertising claims, the court noted.
In its conclusion, the court stated that, "Pfizer has not established that the FDA has determined that all of Pfizer's promotional material strikes a "fair balance" and are not false and misleading."
"Accordingly," the court ruled, "Pfizer's motion to dismiss the false advertising claims on conflict preemption grounds is denied."
There is certainly ample evidence to present to a jury to back up the claims that the Celebrex makers engaged in false advertising and over-promotion of Celebrex, within the walls of the various FDA offices alone.
First off, Pfizer's claim that Celebrex ads were preapproved by the FDA is dead in the water. On December 1, 2005, Tom Abrams, director of the DDMAC, said in an interview for Pharmaceutical Executive that although FDA regulations require companies to submit advertising material at the time of first use, his office receives an average of 53,000 promotional items a year and his staff of 35 cannot handle that volume of screening.
"DDMAC has limited resources and we use our limited resources as effectively as we can to do our job," he said.
In fact, Mr Abrams says the biggest misconception is that the FDA approves all ads before they are released, and most ads are launched without the agency reviewing them. In fact he states, "Often, we're seeing it at the same time as the American public."
According to Mr Abrams, when the FDA determines that an ad violates regulations, the agency sends the company either a notice of violation letter or a warning letter. Notice letters are issued for the least serious offenses and warning letters are issued for serious or repetitive violations and request that the company stop the promotion, and disseminate corrective messages.
FDA records show that Celebrex received seven citations for false or misleading promotions between 1997 and 2005. In 1997, before Celebrex even obtained FDA approval, the FDA accused Celebrex maker at the time, GD Searle, of touting the drug on the internet as "a breakthrough in arthritis therapy,'' and suggesting that it caused no gastrointestinal bleeding.
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