Pfizer and Lilly Pay for Marketing Practices

New York (Oct. 22)-Pfizer completed agreements with 33 states and the District of Columbia to resolve claims primarily related to alleged promotional practices for its “Bextra” pain medication. Last week, the company agreed in principle to resolve the states’ claims by paying $60 million and adopting compliance measures that complement Pfizer’s previously established policies and procedures.

In the lawsuits, the states accused Pfizer of failing to properly research Bextra’s known risks; failing to properly test the drug; failing to warn doctors, patients, and others about the drug’s potential risks; and failing to withdraw the drug from the market after its dangers became widely known. Under the settlements, Pfizer denies the states’ allegations that its promotional practices violated state laws. In response to allegations contained in documents filed by the states, the company said:

• It shared safety and efficacy data for Bextra with the US Food and Drug Administration in a timely manner.

• The Bextra label described the drug’s approved indications, contained all of the scientific data the FDA deemed relevant, and was widely available to physicians.

• The studies discussed in the complaints and provided to physicians were principally written by doctors who did not work at Pfizer and were subjected to rigorous peer review before they were published in respected journals.

• The coronary artery bypass graft (CABG) studies cited in the complaints examined the investigational use of an intravenous form of Bextra and are not applicable to other treatment situations. The CABG studies’ safety findings were not replicated in other studies or other surgical settings. FDA acknowledged in 2005 that it could not determine the significance of the CABG data for patients in other contexts. FDA also said that the sum of the Bextra data did not demonstrate that the medicine posed a different level of cardiovascular risk than other prescription nonsteroidal anti-inflammatory drugs.

• Pfizer responded to physicians’ queries with truthful and relevant safety and efficacy data and included a copy of the Bextra label.

In a company press release, Amy W. Schulman, senior vice-president and general counsel of Pfizer, defended the drug. “Bextra brought effective pain relief to millions of arthritis patients who did not find relief with other treatment therapies. This medicine was rigorously studied and tested by the company and independent medical experts, and information about its benefits and risks was fully disclosed to the FDA.” Pfizer voluntarily withdrew Bextra from the United States market in 2005.

In a related story, Eli Lilly and Company (Indianapolis) announced on Oct. 21, 2008 that it is negotiating a resolution of the ongoing investigations, led by the US Attorney’s Office for the Eastern District of Pennsylvania, of past US marketing and promotional practices for its “Zyprexa” (olanzapine) antipsychotic medication. Lilly will record a charge of $1.415 billion ($1.29 per share) in the third quarter of 2008.

Lilly adopted an enhanced compliance program to ensure that its global marketing and promotional practices fully comply with relevant laws. The program includes the elements of compliance guidelines issued by the US Department of Health and Human Services’s Office of Inspector General for the pharmaceutical industry.

“The government's investigation of Zyprexa has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues,” said Robert A. Armitage, Lilly’s senior vice-president and general counsel, in a company press release.

If the ongoing discussions are successfully concluded, Lilly expects to settle the Zyprexa-related federal claims, as well as similar Medicaid-related claims of states participating in the settlement.

On Oct. 7, 2008, Lilly resolved a multistate investigation under the consumer-protection laws of 32 states and the District of Columbia related to the sales, marketing, and promotion of Zyprexa for $62 million. In March, Lilly entered into a $15-million settlement with the State of Alaska, which concluded an ongoing trial involving various issues surrounding Zyprexa.