Par filed a Complaint for Declaratory and Injunctive Relief against the United States, the U.S. Food & Drug Administration (FDA), the Commissioner of the FDA, and the Secretary of the Department of Health & Human Services seeking a declaratory judgment that the application of FDA off-label marketing regulations to Par’s marketing of Magace® ES violates the First Amendment.  Par believes that those regulations unlawfully prevent it from engaging in truthful speech regarding approved uses of Magace® ES with healthcare providers that may prescribe the drug for off-label uses.  There is no dispute that physicians are legally permitted to prescribe a drug for off-label uses.  Moreover, Par alleges that Magace® ES is prescribed more often for off-label uses.  However, as Par notes, the Government has prosecuted manufacturers under the federal False Claims Act for marketing a drug in settings where it was likely to be prescribed for off-label uses.  For example, the Government brought actions against Eli Lilly in connection with its marketing of Zyprexa and Pharmacia regarding its marketing of Bextra.  Presently, Par believes it is under investigation for its sales and marketing practices of Magace® ES as it received a subpoena in March 2009.  (Click here for our prior post regarding potential FCA exposure based on allegations of off-label marketing.)  Par alleges:  “The ongoing threat of prosecution for alleged ‘off-label promotion’ based on Par’s truthful and non-misleading speech to healthcare professionals concerning the FDA-approved use of Par’s FDA-approved prescription drug currently chills Par’s speech.” 

Par alleges that the FDA's “intended use” regulations of 21 C.F.R. §§ 201.100 and 201.128 are broad enough to reach a manufacturer’s speech “concerning exclusively the FDA-approved, on-label uses of a prescription drug” if the speech occurs “in a setting where physicians exercising independent medical judgment prescribe the drug off-label.”  In such a situation, a manufacturer would be required to provide “adequate directions” on the labeling for the off-label use, which of course is impermissible (since only information regarding FDA-approved uses may be on the labeling).  Par claims that the FDA regulations create a Catch-22 for a manufacturer that speaks about an on-label use to a medical provider that prescribes the drug for an off-label use:  “[Changing the drug’s labeling to add directions for the off-label use violates the Act’s criminal ‘new drug’ rule, but based on the government’s view of the FDA’s ‘intended use’ regulations, not changing the labeling to add those directions violates the Act’s ‘misbranding’ rule.”

Par states that this Catch-22 prevents it from marketing Magace® ES, which is approved for treating loss of appetite, malnutrition, and weight loss in patients with AIDS, called “AIDS-related wasting.”  Par contends that, while the drug is prescribed for AIDS-related wasting, the majority of the prescriptions are for off-label uses, frequently for geriatric and cancer patients.  Par seeks a declaratory judgment that would allow it to market Magace® ES for on-label uses in long-term care and oncology settings where Par knows that physicians may prescribe it for off-label uses.