OFF-LABEL DRUG USE AND THE ROLE OF THE FDA

When discussing promotion of unapproved uses of drugs in terms of the First Amendment, five separate missions intersect, Richard Cooper of Williams & Connolly told the US Food and Drug Law Institute annual seminar (Marketletter June 6). They are:

- the Food and Drug Administration, trying to preserve its jurisdiction over the approval process which safeguards public health and safety; this has been lost, effectively, since off-label uses are common;

- investigators, who want all parties to have access to the discovery and confirmation of scientific truths. The scientific community can deal with bias and distinguish between scientific documents and promotional material;