The Washington Legal Foundation (WLF) this week urged the U.S. District Court for the District of Columbia to uphold First Amendment rights by limiting the authority of the Food and Drug Administration (FDA) to bar drug manufacturers from speaking truthfully about off-label uses of their products. In a brief filed in support of a motion by
Allergan, Inc. for a preliminary injunction against FDA enforcement action, WLF argued that FDA has not provided sufficient justification for interfering with such speech when directed to medical professionals.
WLF filed its brief on behalf of several organizations representing patients that have a significant interest in encouraging open communications between their doctors and Allergan – the National Spasmodic Torticollis Association and the National Spasmodic Dysphonia Association. WLF also filed its brief on behalf of itself and the Allied Educational Foundation. WLF filed its brief with the pro bono assistance of Coleen Klasmeier, Eric Shumsky, Paul Kalb, and Brad Berenson, attorneys with the Washington, D.C. office of Sidley Austin LLP.
“Off-label” uses of a drug or medical device are uses of an FDA-approved product that have not received explicit FDA approval. Although federal law prohibits the manufacturer from specifying on the label any uses of the product other than the precise uses approved by FDA, doctors are free to prescribe FDA-approved products for uses other than those specified on the product label. Indeed, the medical community’s knowledge regarding the safety and efficacy of FDA-approved products inevitably outpaces FDA-approved labeling, with the result that a large percentage of state-of-theart medical treatments involves off-label uses.
Allergan, Inc. is the manufacturer of Botox, a drug approved by FDA to treat several conditions, including cervical dystonia. Dystonias are involuntary muscle contractions, and Botox is injected into the affected muscles to relax them. FDA has not approved Botox for treatment of other dystonias, including spasmotic dysphonia – a neurological voice disorder that causes the vocal chord to spasm and thereby prevents speech by those with the condition. Off-label use of Botox is considered the standard of care for tr eating spasmodic dysphonia. Because spasmodic dysphonia is often diagnosed by a neurologist but is treated by an otolaryngologist, it tends to fall between specialties, and few doctors possess both detailed knowledge of the disease and the expertise regarding how to make injections into the larynx. Allergan employees are among the few individuals with that combined expertise, and thus treating physicians are dependent on Allergan for vital treatment information – such as proper dosaging. But because of FDA speech limitations, Allergan risks criminal prosecutions if it attempts to provide such information to doctors.
In its brief urging the court to enjoin FDA efforts to prohibit truthful speech by
Allergan employees, WLF argued that the First Amendment fully protects such speech.
WLF further argued that even if Allergan’s speech could be deemed commercial in nature (and thus entitled to a somewhat reduced level of constitutional protection), FDA’s speech restrictions still violate First Amendment norms. WLF argued that FDA has failed to demonstrate either that its speech restrictions directly advance any substantial government interests, or that the restrictions are narrowly tailored. WLF stated that FDA’s restrictions are a paternalistic effort to control the content of scientific discussion and a disservice to public health.
WLF noted that FDA is free to restrict Allergan’s speech to the extent that it believes that the speech is misleading, and to require Allergan to attach appropriate disclaimers to its speech – such as a warning that FDA has not approved the off-label uses that Allergan is discussing.
This is an important case in that if settled for the Allergan, many of the cases pending in state courts and by the IOG will be dismissed because they largely cover a very literal interpretation of restricting communications of “off label” information.