Vanda Challenges FDA Over Limits on Off-Label Drug Communication

Vanda Pharmaceuticals is pushing back against the U.S. Food and Drug Administration (FDA), accusing the agency of stifling the dissemination of important medical information. The biotech company filed a lawsuit last week, aiming to secure the right to share data supporting off-label use of its sedative drug Hetlioz for treating jet lag.
The lawsuit, submitted on April 9 to the U.S. District Court for the Southern District of Texas, criticizes what Vanda describes as an overly restrictive regulatory framework. The company argues that the FDA is infringing on its First Amendment rights by limiting how pharmaceutical firms can inform healthcare professionals about alternative uses for approved medications, according to a report by Fierce Pharma.

Hetlioz, approved by the FDA in 2014 for non-24-hour sleep-wake disorder, later gained an additional approval to treat sleep disorders related to Smith-Magenis syndrome. Vanda now seeks to promote the drug for jet lag, an indication not currently authorized by the FDA.
While physicians are legally allowed to prescribe drugs for off-label uses, the FDA places tight controls on the type of information manufacturers can distribute regarding these unapproved applications. According to recent FDA guidance, companies must provide all necessary and accurate information to help healthcare providers evaluate the risks and benefits of such uses. However, the content must remain non-promotional, truthful, and not misleading. Communications must also clearly state that the use is not FDA-approved and disclose any known risks.
Vanda contends that these policies hinder innovation and delay the sharing of emerging clinical insights. In a press release, the company stated that the restrictions deter pharmaceutical companies from sharing valuable findings with physicians, fearing regulatory backlash. This, Vanda argues, ultimately harms patients by denying them access to potentially beneficial treatments.
In its legal filing, Vanda included clinical data demonstrating Hetlioz’s safety and effectiveness for jet lag patients, despite the lack of formal approval. The company is asking the court to affirm that this information is accurate and should be legally permissible to share.
This lawsuit adds to the growing tension between Vanda and the FDA. In 2019, the FDA declined to approve Hetlioz for jet lag, prompting Vanda to appeal. After receiving no response for over two years, the company sued the agency in 2022 for failing to meet required decision timelines.

The dispute doesn’t end there. In 2024, the FDA also rejected Vanda’s application for tradipitant, an NK-1R antagonist for gastroparesis. Vanda argued that the agency dismissed significant clinical evidence and missed its statutory 180-day decision deadline by over 185 days. The company took its case to then-FDA Commissioner Robert Califf in January, criticizing the agency for a lack of transparency and what it called a “culture of obfuscation and closemindedness.”
Shortly after Vanda’s letter, the FDA responded with its rationale for rejecting tradipitant and offered the opportunity for a hearing, signaling a small step toward dialogue amid the broader regulatory conflict.