Given the potential health risks of taking medication, regulations concerning advertising claims about drugs can be considerably more stringent than in other industries. When drug makers run afoul of those requirements, the penalties can be gigantic. New York Attorney General Erich Schneiderman’s office announced on Aug 6 that alongside 40 other states, NY has reached a settlement with Wyeth Pharmaceutical over alleged deceptive advertising practices related to one its flagship products.
In the deal, Wyeth, a subsidiary of Pfizer, has agreed to pay $35 million to settle allegations of improper marketing and promotion of the immunosuppressive drug Rapamune. Depending on the number of consumers impacted, states can expect to collect different totals; New York will recover $1.7 million. The settlement comes following a 2012 decision that left Wyeth on the hook for $491 million to settle civil and criminal liabilities over similar issues.
“There has to be one set of rules for everyone, no matter how rich or powerful, and that includes big pharmaceutical companies that make unapproved and unsubstantiated claims about products in order to boost profits,” said Schneiderman in a statement announcing the settlement. “Patients and consumers need to have confidence in the truthfulness of claims made to them by medical providers without having to worry about drug companies manipulating the doctor-patient relationship. Their health and well-being depend on it.”
Wyeth allegedly marketed Rapamune to aid in the treatment of heart, lung and kidney transplants, when it had only received Food and Drug Administration (FDA) clearance for uses associated with kidney transplants. The company was also charged with employing doctors to promote the use of the drug by releasing misleading studies and encouraging use of the drug not supported by its FDA approval. The Department of Justice is still investigating the marketing practices of Wyeth prior to its 2009 Pfizer back out.
For its part in the settlement, Pfizer has agreed to a number of terms, including ceasing promotion of its FDA-approved drugs for unlabeled uses, and seeking to influence the use and prescription of Rapamune.