Md. Receives $42.9M from Pfizer Settlement

Unfair and deceptive marketing of Zyvox and Lyrica alleged

BALTIMORE (December 12, 2012)—Attorney General Douglas F. Gansler announced today that he, joined by 32 other attorneys general, has reached a $42.9 million consent judgment with Pfizer Inc to resolve allegations that Pfizer Inc unlawfully promoted its drugs, Zyvox® and Lyrica®. The pharmaceutical manufacturer is alleged to have engaged in unfair or deceptive trade practices in its promotion of Zyvox® by making misleading and unsubstantiated superiority claims. Pfizer is also alleged to have engaged in unfair or deceptive trade practices in promoting Lyrica® for off-label uses.

“Patients could face serious risks when major pharmaceutical companies claim that a drug has health benefits that are unproven,” said Attorney General Gansler. “This office will stay vigilant against the deceptive marketing of drugs that threatens the health and well-being of Marylanders.”

In its promotions, Pfizer is alleged to have broadened the indications of Lyrica and Zyvox®, an antibacterial agent approved to treat certain types of infections, including among other approved indications, nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus (“MRSA”) and complicated skin and skin structure infections due to MRSA. Lyrica® had been approved by the FDA for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN), post-herpetic neuralgia (PHN) and for adjunctive therapy for adult patients with partial onset seizures. In 2007, the FDA approved Lyrica® for the treatment of fibromyalgia.

As part of the Consent Judgment, Pfizer Inc agreed to reform how it markets and promotes Zyvox® and Lyrica®. Under the Consent Judgment, Pfizer Inc shall not:

-- Make any false, misleading, or deceptive claims when comparing the efficacy or safety of Zyvox® to vancomycin;

-- Promote any Pfizer product for off-label uses;

-- Fail to design financial incentives that ensure that its marketing personnel are not motivated to engage in the improper marketing of Zyvox® or Lyrica®; or

-- Fail to notify its sales force promptly of any warning letter received from the FDA that affects sales representatives in the promotion of Pfizer products.

Source: Office of Attorney General Douglas F. Gansler

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