WLF Supports Allergan’s Challenge to FDA’s Policies on Off-Label Speech

December 2, 2009

By Carrie S. Martin –      

On November 19, the Washington Legal Foundation (“WLF”), along with three other organizations, filed an amicus curiae brief in support of Allergan, Inc.’s First Amendment challenge to FDA’s ban on “truthful, accurate and nonmisleading speech” proactively disseminated to health care professionals (“HCPs”) about off-label uses of FDA-approved prescription drugs.  

On October 1, Allergan filed a Complaint and a Motion for Preliminary Injunction in the United States District Court for the District of Columbia to prevent the FDA and the federal government from enforcing regulations and policies that would prohibit Allergan from proactively sharing information with HCPs on an off-label use of BOTOX (botulinumtoxin type A) for injection to treat spasticity in certain patients.  Allergan stressed that it was “not seek[ing] to engage in direct-to-consumer communications about the off-label use of Botox,” but instead wanted to inform HCPs about safety data regarding the use by distributing safety information to physicians who treat spasticity through “medical and scientific representatives,” distributing printed and electronic information to physicians, and making formal presentations at scientific meetings and conventions, among other things.  As Allergan points out, this speech currently runs afoul of FDA regulations and government policies and renders a company vulnerable to criminal prosecution and civil penalties.
Such policies and regulations regarding off-label communications, according to Allergan, violate the First Amendment and are patently inconsistent with the Federal Food, Drug, and Cosmetic Act (“FDC Act”).  In addition, the regulations and policies “impair[] public health and safety” by prohibiting the company from disseminating information about risks of serious adverse events to physicians already using Botox for this off-label use. 

Allergan attributes the overly restrictive regulatory landscape to the expansion of several related and intertwined regulations and policies.  Among them is the “radical[] expan[sion]” of the regulatory definition of “labeling” to include any material that contains company-generated and distributed information about a drug, whether or not it physically “accompan[ies]” it, 21 C.F.R. § 202.1(l)(2), which in turns makes it unlawful for a pharmaceutical company to distribute material about an off-label use under the FDC Act, because such information renders the drug a “new drug.”  In addition, because the federal government considers all speech about an off-label use “false or misleading,” such speech misbrands a drug under section 502(a) of the FDC Act. 

WLF’s brief supplements Allergan’s complaint by expounding on two topics: (1) the importance of off-label uses to the practice of medicine and how overregulation of off-label speech is contrary to public health; and (2) the “three foundational First Amendment principles” necessary to resolve Allergan’s claims.  With regard to the first topic, the brief stresses that manufacturers are in the best position to provide important off-label information because they – simply put – have the best access to and understanding of that information and the resources to disseminate it.  In addition, the amici curiae argue that this information is critical to HCPs, because, among other reasons, off-label uses of prescription drugs often constitute the standard of care. 

With regard to the “foundational First Amendment principles,” the brief notes that the First Amendment is always implicated when the government limits truthful, accurate and non-misleading speech, including when such speech is from a manufacturer regarding off-label uses of approved drug products.  Furthermore, the speech at issue here—truthful, nonmisleading speech from a prescription drug manufacturer to HCPs about the safety and efficacy of an off-label use of a prescription drug – is not commercial, but rather scientific speech that receives “strict scrutiny” in a First Amendment analysis.  According to the brief, the fact that the manufacturer may benefit financially from that speech does not automatically make it commercial speech.  And even if the speech was commercial, which receives intermediate scrutiny, the WLF brief argues that the government’s restrictive policies and regulations would still be found unconstitutional, because the “First Amendment forbids the government from paternalistically limiting the flow of information to the marketplace concerning lawful transactions in lawful products.”  

A hearing on Allergan’s Motion for Preliminary Injunction has been set for March 2010.  Regardless of the outcome, it is likely that this fight – given its history and its potential impact on manufacturers and the federal government – will not end until it reaches the steps of the United States Supreme Court.

Categories: Drug Development