Florida joins $60 million judgment against Pfizer, Inc.
Florida joins $60 million judgment against Pfizer, Inc.
OCTOBER 23, 2008 – Attorney General Bill McCollum yesterday announced that Florida has joined 32 other states and the District of Columbia in a $60 million settlement judgment against Pfizer, Inc., resolving a five-year investigation into the company’s marketing practices of certain pharmaceuticals. In addition to the financial aspects of the resolution, the settlement will largely
affect Pfizer’s marketing practices for its products. Florida was a member of the Executive Committee which negotiated the settlement.
"The comprehensive injunctive relief obtained in this case is outstanding and addresses all concerns identified over five years of investigation," said Attorney General McCollum.
The multistate investigation into Pfizer’s marketing practices focused primarily on the promotion of anti-inflammatory "Cox-2" prescription drugs Celebrex and Bextra, specifically on claims that Celebrex was safer and more effective than traditional – and less expensive – non-steroid anti-inflammatory prescriptions. The investigation, launched in 2003, also included Pharmacia, a company subsequently purchased by Pfizer.
As the investigation regarding Celebrex proceeded, additional concerns were raised about Bextra, another pharmaceutical manufactured by Pfizer. Ultimately, the investigation concluded that Pfizer engaged in an aggressive, deceptive and unlawful campaign to promote Bextra for "off-label" uses that had been expressly rejected by the Food and Drug Administration (FDA). While a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
Although significantly more expensive than traditional non-steroid anti-inflammatory prescriptions, Cox-2 drugs have not been shown to be more effective, and neither Celebrex nor Bextra were ever proven to significantly reduce serious side effects. Moreover, Cox-2 drugs can potentially increase the risk of serious cardiovascular side effects including heart attacks and strokes, and Bextra carries an additional risk of a serious and sometimes fatal skin condition. In 2005, Bextra was withdrawn from the market place and the FDA required a "black box" safety warning for Celebrex, the highest level of required disclosure.
Throughout the investigation, the states alleged that despite the fact that significant safety concerns led the FDA to reject a request to market Bextra for acute and surgical pain, Pfizer conducted a promotional campaign for those very uses. The company’s marketing tactics allegedly included co-opting influential doctors; distributing hundreds of thousands of samples of high-dose Bextra to doctors whose only possible use for high-dose Bextra was off-label; providing prizes and otherwise encouraging sales representatives to promote Bextra off-label; and using imagery and language in advertisements that implicitly promoted Bextra’s off-label usage.
The states also alleged these efforts continued even after Pfizer completed a study that confirmed the FDA’s reason for rejecting Bextra as a treatment for acute and surgical pain. This study ultimately contributed to the FDA’s decision to withdraw Bextra from the marketplace, even at the low doses that had been previously approved.
The judgment, which is pending judicial approval, contains injunctive terms addressing the concerns raised regarding both Celebrex and Bextra during the investigation. These terms were included to help prevent the following practices:
- Deceptive use of scientific data when marketing to doctors;
- "Ghost writing" of articles and studies or distributing off-label studies and articles in a promotional manner;
- Distributing samples with the intent to encourage off-label prescribing;
- Distributing information about an FDA-rejected off-label use unless Pfizer clearly discloses that the FDA rejected the use and provides the reason the use was rejected;
- Providing incentives to sales staff to increase off-label prescribing;
- Promoting drugs off-label for inclusion in hospital standing orders and protocols;
- Using grants to encourage use of Pfizer products; and
- Using patient testimonials to misrepresent a drug’s efficacy.
Additionally, the judgment requires Pfizer to submit all "direct-to-consumer" television advertisements to the FDA for approval and comply with any FDA comment before running the advertisement. The judgment also generally prohibits Pfizer from deceptive advertising or promotion of any Pfizer drug, requires Pfizer to register all clinical trials and post clinical trial results, and ensures that subjects in Pfizer-sponsored clinical trials give adequate informed consent. Florida’s share of the settlement is $3.4 million and will be used to fund future enforcement efforts and to reimburse the Attorney General’s Office for its fees and costs.
