Whistleblower Attorneys Blog
Allergan recently brought an injunctive action against the FDA asserting the unconstitutionality of several of its provisions regulating off-label promotion. Advancing their First Amendment argument, Allergan employs many of the same arguments put forth in Caronia (for more information on this topic, see here). However, a primary difference distinguishing Allergan from Caronia lies within Allergan’s Risk Evaluation and Mitigation Strategy. As Allergan argues, providing warnings in compliance with the FDA’s requests constitutes government-compelled speech (warranting strict scrutiny).
More likely, however, the speech will be deemed commercial speech and will warrant application of the Central Hudson test, as applied in Washington Legal Foundation and Caronia. Even if this test is applied, Allergan argues the following:
• The FDA interprets statutory language too broadly, especially the definition of “labeling.” However, the FDA’s interpretation of labeling is based upon years of case law.
• Off-label speech regarding uses that are already prevalent and accepted in the medical community- so much so that Medicaid reimburses them- cannot be banned. This, too, is a tenuous argument because Medicaid reimbursement and FDA approval rely on entirely different criteria. Medicare and Medicaid use non-governmental drug compendia and peer-reviewed medical literature when deciding to reimburse off-label uses. The FDA, on the other hand, relies on controlled clinical studies to determine a drug’s safety and efficacy.
• Off-label promotion of a drug after it has been submitted for FDA approval for that off-label use should not be banned. Lastly, many drug companies confuse the government’s interest. While Allergan believes that this interest is served simply by applying for FDA approval, it is not simply the filing of the supplemental application that is the end in itself. Rather, it is the FDA approval process to evaluate the effectiveness and safety of the drugs for those uses.
• The FDA forces pharmaceutical companies into a Catch-22 situation: drug manufacturers who intend new uses of their drugs violate the FDCA if they do not add adequate directions for use on the drug’s labeling. However, if they do, they violate the prohibition against distribution of unapproved new drugs. While many drug manufacturers complain of this alleged “Catch-22” this supposed dilemma is simple impatience. Allergan wishes to begin promoting a new drug for a use before that use has been approved by the FDA.