Is FDA Promoting Off-Label Uses?

Attorney James Beck (Reed Smith) says that with its announcement of the availability of CURE ID, an Internet-based repository of physician information on off-label success stories, FDA appears to be getting into the off-label promotion business itself. Writing in the Drug and Device Law blog, Beck says FDA explained that CURE ID “will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs.”

He quotes an agency news release that “repurposing approved drugs for new clinical indications can potentially offer an efficient drug-development pathway.” Beck also notes that FDA will use CURE ID to promote the novel uses to the medical community, as a forum for doctors to come together to discuss promising off-label uses.

“Thus,” Beck writes, “FDA not only recognizes the clinical benefits of off-label use itself, but it recognizes — and intends to encourage — the promotion of such uses to the medical community generally. So we extend a rather belated ‘welcome to the club’ to FDA. FDA’s jumping aboard the truthful off-label promotion bandwagon can only benefit the public health.”

He points out that the FDA statement on CURE ID is silent as to the role of the only entities — drug manufacturers — that the agency formally regulates. He says that companies are obligated to report adverse events that occur in connection with off-label use of their products, and should be equally required, or at least encouraged, to report successes as well. “A reporting system that focuses solely on risks, while ignoring benefits (whether the use is on- or off-label) would inevitably produce skewed results that inhibit medical innovation,” he concludes. “After all, the same ‘emerging signals’ that might reflect risk, can just as well reflect benefits.”

Beck says that with the agency now engaging in truthful off-label promotion itself, he is waiting for it to formally remove its ban on regulated entities doing the same. “Not only is CURE ID beneficial to the public health, but it also starkly demonstrates how the current regime is a speaker-based prior restraint against the First Amendment-protected scientific speech of manufacturers,” he says.