FDA Guide Reshaping Off-Label Communications: Legal Analysis

An FDA guidance issued last year is reshaping how pharmaceutical and medical device companies can communicate scientific information about off-label uses of approved products, while also creating new compliance challenges for industry, according to a legal analysis by Suzanne Levy Friedman (Honigman partner) posted in Life Science Leader. The guidance, known as the Scientific Information on Unapproved Uses, or SIUU, framework, provides manufacturers with expanded flexibility to share scientific information with healthcare providers regarding uses not formally approved or cleared by FDA (see earlier story).

In the guest column, Friedman said the finalized policy marks one of the most significant liberalizations of FDA’s approach to off-label communications in decades. Among the most notable changes, the agency now explicitly allows sales and marketing personnel to share certain off-label scientific information during physician detailing visits and permits companies to post such materials on corporate Web sites under defined conditions.

The guidance also broadens the types of evidence that may qualify for dissemination under the agency’s “safe harbor,” moving beyond traditional peer-reviewed journal reprints to include additional scientifically sound data sources, Friedman says. Drugmakers and medical device manufacturers have long sought clearer rules governing off-label communications, an area that has generated legal and constitutional disputes for decades because physicians may legally prescribe products off-label even though manufacturers are generally prohibited from promoting unapproved uses.

Friedman noted that the new framework removes the term “clinically relevant” from the formal standard governing eligible source publications, a change industry groups had pushed for because they viewed the phrase as overly subjective and restrictive, she wrote. The guidance also permits “firm-generated presentations” based on qualifying scientific publications and acknowledges that sales representatives may communicate both promotional and non-promotional scientific content if appropriately trained. At the same time, FDA maintained significant guardrails intended to prevent scientific exchange from becoming disguised marketing.

The agency specifically warned against the use of celebrity endorsements, emotional appeals, promotional slogans, gifts and certain marketing-oriented “calls to value” in conjunction with off-label scientific communications.

Friedman wrote that while the guidance offers manufacturers more regulatory certainty after years of reliance on draft policies, companies still face substantial compliance risks if they fall outside the safe harbor.

She pointed to increased FDA enforcement activity beginning in late 2025 involving allegedly misleading off-label claims and promotional materials that exceeded the scope of approved indications or device clearances.

The article also warned that companies seeking to use the new flexibility will need extensive compliance systems, including updated disclosure practices, careful platform selection and specialized employee training programs.

“The policy finalized in 2025 is still more restrictive than many manufacturers would like,” Friedman wrote, “but it is also the clearest framework the industry has ever had.”