Although drug makers are forbidden to promote, market or advertise drugs for any indication other than those approved by the FDA, that hasn't stopped physicians from legally writing "off-label" prescriptions. Rosenheck estimates roughly 60% of prescriptions for atypical antipsychotics have been written off-label.
In January, Eli Lilly & Co., which makes the atypical antipsychotic Zyprexa, was ordered by the Justice Department to pay more than $1.4 billion in penalties in connection with alleged illegal off-label marketing efforts. The company admitted no wrongdoing. The attorneys general of several states have sued the makers of Seroquel and Risperdal, alleging they've unlawfully marketed their medications to state Medicare and Medicaid agencies. The suits, still pending, allege that widespread prescribing of the drugs, encouraged by pharmaceutical companies that downplayed risks, caused harm to patients and unjustified cost to taxpayers.
One spokesperson for AstraZeneca, which makes Seroquel, says the company "fully supports the work of the FDA" in assessing the drug's benefits and risks in the treatment of depression and anxiety.
Responding to allegations made in several states' suits, another spokesman, Tony Jewell, said Seroquel's detailed package insert "has always provided adequate and appropriate information and warnings based on available data."
Currently, of all the atypical antipsychotics, only Abilify -- the drug that Leuchter's patients began asking about -- may legally be promoted as a treatment for psychiatric conditions other than schizophrenia and bipolar disorder. In November 2007, the FDA granted permission to its maker, Bristol-Myers Squibb, to promote the drug as a treatment for depression that has failed to respond to one or more antidepressants.
The FDA's decision on Abilify came without calling a hearing of its advisory panel on psychopharmacological drugs. In considering AstraZeneca's petition for Seroquel's new use, however, the FDA proceeded with greater caution, asking the committee to sift through the evidence and offer its recommendation.
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melissa.healy@latimes.com
