The consumer advocacy group Public Citizen has filed a petition asking the U.S. Food and Drug Administration (FDA) to correct a labeling error for the sleep disorder drug Hetlioz. The drug was approved early last year to treat a rare condition known as non-24 sleep-wake disorder, where the body’s circadian rhythm is abnormal. According to Wall Street Journal Pharmalot, Public Citizen’s petition states that the FDA made a mistake by failing to mention that the drug is only for patients who are blind on the label.
WSJ Pharmalot reports that the agency became aware of this error at some point last year. Public Citizen’s petition says that instead of correcting the label, the FDA issued another approval letter stating that the original approval letter had an error. The agency then revised the approved use to match the incorrect label, the petition asserts.
Public Citizen’s petition calls on the FDA to change the labeling on Hetlioz to indicate that it is only approved for patients who are completely blind; this encompasses a population of about 100,000. Most patients who have the disorder are blind. However, Public Citizen is concerned that the current label will result in non-blind patients taking the drug.
Additionally, Public Citizen points out that clinical data submitted by the manufacturer, Vanda Pharmaceuticals, did not include non-blind patients. As such, the petition says, the agency violated the legal standard for approving a drug because there was no evidence to show that Hetlioz is safe or effective in non-blind patients with the disorder. The group wants the FDA to ask Vanda to conduct a safety trial.
“The actions taken by the FDA in response to the original mistake in approving [the] erroneous label are unacceptable and deeply disturbing,” Public Citizen’s Health Research Michael Carome said in a statement. “Because of its failures in this matter, the FDA has allowed a potentially dangerous medication to be given to people for whom there is a lack of substantial evidence that it is safe and effective.”
“The FDA’s retroactive decision to expand the approved indication… to non-blind individuals, rather than correct the agency’s embarrassing mistake in approving a drug label that had an incorrect indication, represents an unprecedented and disturbing failure on the part of the agency,” he states. “As a matter of principle, this inappropriate action by the FDA must not be allowed to stand.”