The promotion of drugs by manufacturers for uses not previously approved by the FDA (aka off-label use) is controversial because it may lead to more patients being exposed to medicines with an uncertain risk-benefit profile. In an article published in the New England Journal of Medicine, Drs. Avorn, Kesselheim and Sarpartwari describe a 2015 federal judge ruling on a suit between Amarin pharmaceuticals and the FDA regarding the deliberate off-label promotion of a prescription fish oil product. Rather than addressing the practice of off-label prescribing itself, an issue not addressed in the suit, the case pertains to whether or not the FDA can restrict a manufacturer from marketing a drug to a prescriber for an unapproved use. Historically, the right of the FDA to regulate promotional materials has been based upon the government’s substantial interest in ensuring the safety and efficacy of prescription drugs available to the public. However, in recent years, both the courts and the agency itself have relaxed the FDA’s ability to restrict off label promotion, in part so that the government does not restrict “commercial free speech.” The authors discuss the potential negative impact of relaxing the FDA’s ability to police the marketing of drugs for unapproved uses, namely that larger numbers of patients will be exposed to increase risk without a rigorous evaluation of evidence supporting clinical benefit.
Read the full article here.