“A recent court ruling that favored freedom of speech over the authority of the US Food and Drug Administration (FDA) to regulate off-label drug promotion may have profound implications for the way drugs are marketed and, ultimately, for patients’ interests.”
The off-label use of medication in the medical community is common practice. A doctor or even friends may recommend that you use a drug for ailments that may not be specifically associated with the drug in question and the drug’s efficacy to treat that particular ailment is clinically untested.
“Under the Food, Drug and Cosmetic Act (FDCA), which gives the FDA its regulatory authority, it is a crime to promote a drug for purposes not listed in its label.”
Alfred Caronia, a sales representative for Orphan Medical, recently promoted a drug, Xyrem, whose active ingredient is g-hydroxybutyrae or the date rape drug, for uses not approved by the FDA, such as for fibromyalgia, restless legs syndrome, chronic pain and Parkinson’s disease
What is astonishing is that In a 2-to-1 decision, the judges stated that banning off-label marketing violated the representative’s freedom of speech.
The decision may be appealed, but if it is not this will have serious repercussions. Researchers are currently supposed to test a drug’s efficacy in treating specific condition. Even if an FDA-approved drug may be useful in treating a condition if its efficacy in treating that specific condition is not clinically tested then it is illegal to promote it for a purpose not listed in its label.
Clinical trials have generated many “me too” drugs (new drugs which are slight variants of drugs that are already on the market), and have encouraged researchers to publish and make money off of drugs that are already on the market by testing their potential efficacy for other conditions, trends which do not encourage innovative, clinical trials for entirely new drugs. However, as this article shows, it is important to emphasize the need for drugs to undergo rigorous clinical trials for each specific purpose in order to ensure their safe consumption by patients.
nature1 (click to read the NatureMedicine editorial)