FDA Allows Drugmakers to Advise Doctors on Alternative Uses

Scott Kappes

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Today regulators from the FDA issued guidelines for medical device and pharmaceutical companies to advise physicians about non-FDA-approved uses for their products. The original proposal, which was finalized today, allows devices manufacturers and drug makers to distribute medical journal articles describing unapproved uses.

By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for unapproved uses, a practice known as "off-label" use.

The new guidelines allow manufacturers to distribute medical literature that may suggest that a drug or device may be useful for unapproved uses.

The agency stated that they understand that this process could benefit public by providing health care professionals with scientific data and medical information that may not have been available in the past.

The FDA also added a statement to the provision encouraging companies to seek FDA approval for unapproved uses they believe their products may be useful in treating.