FDA Considers Off-Label Guidance
The FDA issued draft guidance, published in the Federal Register, describing appropriate practices for manufacturers to distribute materials describing unapproved uses for both devices and drugs that already have marketing clearance, but for different indications. A simultaneous goal of the guidance is to prevent off-label promotions by manufacturers, as described in a New York Times article describing the federal move.
The new rule indicates that compliance with the newly issue rule would not be considered promotion for unapproved uses. Articles must be peer-reviewed and published in journals with an editorial board comprised of experts. The rule replaces a provision that was incorporated in the FDA Modernization Act, which allowed distribution of some medical journal articles describing benefits of off-label use. Drug manufacturers are not held to the same standards as when they seek FDA approval for specific indications.
The FDA still retains the authority to examine materials distributed to determine if such comply with the new rule proposed. As well, manufacturers must maintain compliance with the Federal Food, Drug and Cosmetic Act. That requires that products are not adulterated or misbranded.
Representatives from the FDA note the potential benefits for patients when treatment is delivered off-label, particularly for those patients with rare conditions. In fact, the standard of care treatment for some diseases dictate use of therapies off-label; meaning delivery for non-indicated conditions. As well, this ruling could allow more rapid adoption of new therapies rather limiting clinicians until the FDA grants marketing clearance.
Members of Congress, among other critics of the proposal, are concerned that the proposed rule is too broad and does not follow the intent of the initial provision included in the Modernization Act. Some argue that this will expand sharing of materials detailing off-label use of both pharmaceuticals and devices.
The Public Citizen’s health research group cites that patients lives will be placed in the balance without adequate data assessing risks versus benefits. Others note that this new rule bows to the power of the pharmaceutical industry, without requiring strict standards proving both efficacy and safety.
Interestingly, data collected during 2006 suggests that wholly one-fifth of medications prescribed were for off-label indications.
February 22, 2008 Related topics: Legal & legislative, Quality, Safety, Errors, Pharmaceuticals