Vanda called the attention of FDA Commissioner Robert Califf to what it termed the “sentiment that the agency avoids public scrutiny of its decisions.”
Vanda Pharmaceuticals on Wednesday sent a letter to FDA Commissioner Robert Califf blasting what it called a “culture of obfuscation and closemindedness” at the agency.
The letter comes after the regulator in September 2024 rejected Vanda’s NK-1R blocker tradipitant for gastroparesis, a disorder characterized by delayed gastric emptying that can lead to malnutrition and other complications. At the time, the biotech said that the Complete Response Letter did not specify the reason for rejection, but contended that it “generally disregarded the evidence provided.”
Vanda called the FDA’s rejection “disappointing” while also criticizing the agency’s “delayed” action. According to the biotech, the FDA’s verdict was late by more than 185 days “and fails to satisfy the requirements specified by the Food Drug and Cosmetic Act,” which requires the agency to, within 180 days of a regulatory submission, issue an approval or otherwise offer the opportunity for a hearing.
“In this case, the FDA failed to do either,” Vanda said in its September news release, adding that the regulator has also denied repeated requests to convene an Advisory Committee to discuss tradipitant’s application.
In its letter to Califf on Wednesday, Vanda put much of the blame on the Commissioner’s shoulders, pointing to his prior public declaration that he would not interfere or overrule decisions made by lower-ranking officials of the agency except in cases of “corruption” or “temporary insanity.”
“Neither the public nor regulated entities like Vanda are able to determine what instances of ‘corruption’ or ‘temporary insanity’ would in your view merit overruling lower-level FDA employee decisions,” the letter stated. “As a political appointee and head of the agency, you are the only person accountable to the American public—a public that needs to know that the agency will follow the law and ensure courteous and civil behavior by agency employees.”
Vanda has been a consistent critic of the FDA. In September 2024, the company sued the regulator over what it claimed were constitutional violations with the agency’s new drug approval process, as per Bloomberg. A few months earlier, in February 2024, Vanda blasted the FDA’s decision to decline a proposed expansion for its drug Hetlioz into insomnia, noting that the “timing of the FDA’s communication is part of an ongoing violation of the Federal Food Drug and Cosmetic Act.”
“Vanda remains committed to its efforts to hold the FDA accountable to the law, ensuring predictable regulatory conduct,” the biotech’s news release stated at the time.
