Attorney General Long Reaches Agreement with Pfizer Over Unlawful Marketing of Drugs
PIERRE, S.D.- Attorney General Larry Long today announced today a stipulated judgment with Pfizer Inc. resolving a five-year investigation by 33 states concerning the company’s promotion of the drugs Celebrex® and Bextra®. South Dakota’s share in the $60 million payment to the participating states is $589,168.00. The judgment will also largely restrict Pfizer’s ability to deceptively promote all Pfizer products.
The multistate investigation was initiated in 2003 to determine whether Pfizer and Pharmacia, another drug company, misrepresented that Celebrex was safer and more effective than traditional non-steroidal anti-inflammatory drugs such as Ibuprofen (Advil®) and naproxen (Aleve®).
As the investigation proceeded, additional concerns were raised regarding Bextra. Ultimately, the investigation concluded that Pfizer engaged in an aggressive, deceptive and unlawful campaign to promote Bextra “off label” for uses that had been expressly rejected by the FDA. “Off-label” uses are uses that are not approved by the FDA. While a physician is allowed to prescribe drugs for off-label uses, law prohibits pharmaceutical manufacturers from marketing their products for off-label uses. In 2005, due to safety concerns, Bextra was withdrawn from the market place and FDA required a safety warning for Celebrex.
In the complaint, Long alleges that despite the fact that significant safety concerns led FDA to reject a request to market high dose Bextra for acute and surgical pain, Pfizer conducted a systematic, multi-pronged “off-label” promotional campaign for these very indications FDA denied by:
- Co-opting influential doctors with paid consultancies and lavish weekends at high end resorts.
- Distributing hundreds of thousands of samples of high dose Bextra to specialties whose only possible use for high dose Bextra was off-label.
- Providing prizes and otherwise encouraging sales representatives to promote Bextra off label.
- Using supposedly non-promotional Continuing Medical Education to promote Bextra off-label.
- Using imagery and language in advertisements that implicity promoted Bextra off-label.
- Misrepresenting Bextra’s safety.
Long alleges these efforts continued even after Pfizer completed a study that confirmed FDA’s reason for rejecting the acute and surgical pain indications for Bextra. This study ultimately contributed to FDA’s decision to withdraw Bextra from the marketplace, even at the low doses that had been previously approved.
Included in the Judgment are terms that will help prevent:
- Deceptive use of scientific data when marketing to doctors.
- “Ghost writing” of articles and studies.
- Failing to adequately disclose conflicts of interest for Pfizer promotional speakers when these consultants also speak at supposedly independent Continuing Medical Education.
- Distributing samples with the intent to encourage off-label prescribing.
- Distributing information about an off-label use when FDA has rejected the off-label use unless Pfizer clearly discloses that FDA rejected the use and FDA’s reason for rejecting.
- Distributing off-label studies and articles in a promotional manner.
- Providing incentives to sales staff to increase off-label prescribing.
- Promoting drugs off label for inclusion in hospital standing orders and protocols.
- Using “mentorships” to pay physicians for time spent with Pfizer sales reps.
- Using grants to encourage use of Pfizer products.
- Using sales personnel to make grant decisions that are supposedly unrelated to promotion and marketing.
- Using patient testimonials to misrepresent a drugs efficacy.
In addition, the judgment requires Pfizer to submit all “direct-to-consumer” (DTC) television drug advertisements to FDA for approval and comply with any FDA comment before running the advertisement. Finally, the judgment generally prohibits Pfizer from deceptive and misleading advertising and promotion of any Pfizer drug, requires Pfizer to register all clinical trials, post clinical trial results, and ensure that subjects in Pfizer sponsored clinical trials give adequate informed consent.
Consumers wanting more information about this settlement may call the South Dakota Consumer Protection Division at 1-800-300-1986.