FDA suggests protocol for off-label data

The Food and Drug Administration this month proposed a new protocol that would enable medical drug and device companies to release off-label information about their commercial drugs, biologics, and medical devices. The agency's proposal could make it easier for companies to inform physicians about new potential uses for products before those applications receive regulatory approval.

The FDA's proposal arises out of the 1997 Food and Drug Administration Modernization Act (FDAMA), and stipulates the particular type of unapproved-use data that can be released. If the new rules are adopted, companies will be able to disseminate information about their products' off-label uses, provided the information pertains to products already approved, licensed, or cleared by the FDA.

Data will be presented in unedited peer-reviewed medical journal articles describing clinical investigations that medical experts consider reliable, and must not mislead the public or pose a threat to public health. The information must also be obtained with permission from other manufacturers who have conducted clinical research. Companies will be required to state clearly that the product's new use is not FDA-approved.

Under the new protocol, a copy of the information will be submitted to the FDA 60 days before the company releases it to the public. The FDA could order the company to stop distributing the information if the agency determined that the off-label use was not effective or posed a health risk. The FDA's proposed rules are open to public comment through late July.