US FDA Concern over "Therapeutic Class Wars"

The US Food and Drug Administration is becoming increasingly concerned with drug switch campaigns involving substitution of a different therapy which may rely on "an unsubstantiated assumption of comparable effectiveness," says an article in the New England Journal of Medicine, signed by FDA Commissioner David Kessler and four other agency officials, including Robert Temple, director of the Office of Drug Evaluation I, and Lucy Rose, director of the Division of Drug Marketing, Advertising and Communications.

Such switches are common in the case of providers of mail-order drugs who contract with companies to feature their drug at a lower price, it says. "From a therapeutic perspective, it is not always clear that such switches are in patients' best interests, because a switch may be based on little more than an unsubstantiated assumption of comparable effectiveness."

The article says a highly competitive marketplace for prescription drugs has been created by the preponderance of "me-too" drugs, with companies waging aggressive campaigns to change prescribers' habits and distinguish their drugs from competing ones even when they are virtually indistinguishable. Specifically, it discusses three increasingly widely-used techniques.