Once a final monograph is in place, companies can make and market an over-the-counter product without the need for FDA pre-approval. These monographs define the safety, effectiveness and labeling of all marketed active ingredients. New drugs that don’t meet an existing monograph must go through the New Drug Application process.
In an industry where the “off-label” use of FDA-approved products is widespread, Anisfeld stresses the importance of understanding both the FDA approval process for drugs and devices, and the ease with which indicated uses can be identified. “It’s very tempting for a salesperson to try to stretch the use of a product beyond its approved indications,” he says. “But that means the doctor is taking full personal and legal responsibility for anything that happens to the patient. Ask the salesperson if the product is approved by the FDA for this indication. The accepted uses also are listed on the package insert.”
Annemarie Mannion is a Chicago-based freelance writer.