Par Pharmaceutical, Inc. has filed a declaratory judgment action against the U.S. Food and Drug Administration (FDA) in a District of Columbia federal court, seeking an order barring the agency from enforcing regulations that criminalize off-label drug promotions on the ground that they violate First Amendment free speech rights. Par Pharm., Inc. v. United States, No. 11-01820 (U.S. Dist. Ct., D.D.C., filed October 14, 2011).  

According to the New Jersey-based generic and branded drug maker, FDA regulations pertaining to unapproved (off-label) uses of approved drugs place manufacturers in a Catch-22 situation: “changing the drug’s labeling to add directions for the off-label use violates the [Food, Drug, and Cosmetic] 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.’ The manufacturer’s truthful speech about on-label use of its drug thus violates at least one of these criminal provisions.”  

Noting that the Act “does not limit or interfere with the authority of healthcare professionals to prescribe or administer any FDA-approved drug to any patient to treat any condition or disease” and that off-label uses are “widespread, medically accepted and government-subsidized,” the complaint contends, “it is critical that healthcare professionals have access to accurate, comprehensive, and current information concerning off-label uses.”  

The complaint specifically addresses the company’s prescription drug Megace® ES, an appetite-stimulant hormone. According to Par Pharmaceutical, while FDA has approved the drug for AIDS-related wasting, the medical community “widely views” it “as one of the most effective treatments for wasting in geriatric and cancer patients.” The company is allegedly unable to conduct placebo-controlled clinical studies for this use because physicians contend that administering a placebo “would be contrary to the best interests of the patients, in light of [the drug’s] accepted off-label use.” Without such testing, the company cannot apply to the FDA for a new drug use to change the product’s labels and promotional materials and thus cannot market it for this widely approved use.

The company seeks a declaration that FDA’s interpretation of the “intended use” regulations “violate[s] the First Amendment as applied to Par’s truthful and non-misleading speech to healthcare professionals concerning on-label use of its approved drug in settings where the drug is prescribed for off-label use, and enjoining defendants from enforcing the regulations to prohibit Par’s speech.”