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