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FDA Mistakenly Expands Approval for Sleep Drug

Jun 15, 2015

When the Food and Drug Administration (FDA) gave approval for Hetlioz (tasimelteon), a drug to treat non-24 sleep-wake disorder, a rare condition, the agency may have inadvertently omitted language from the label indicating that the drug is intended only for patients who are totally blind.

When the FDA became aware of the mistake, it issued a new approval letter. Though the second letter said the original letter contained an error, it did not revise the product labeling but instead changed the description of approved use to match the incorrect labeling, according to the Wall Street Journal.

The consumer advocacy group Public Citizen pointed out the errors and has now petitioned the FDA to correct the label to indicate that the drug is intended only for totally blind patients with the disorder, a population of approximately 100,000, according to the drug maker. Public Citizen is concerned that existing labeling may encourage use of Hetlioz in people who are not blind and have some other type of sleep disorder, according to the WSJ Pharmalot blog.

In its letter to the FDA, Public Citizen asks that Vanda Pharmaceuticals, which manufactures the drug, be required to conduct a large "adequately powered" postmarket clinical trial in totally blind subjects "to obtain more robust safety data in this patient population." In the preapproval safety database, just 139 subjects received tasimelteon for more than 26 weeks and only 183 totally blind subjects with non-24 sleep-wake disorder received the drug at all for any duration. Non-24-hour sleep-wake disorder is a chronic condition for which tasimelteon would be taken for years. The trial should therefore place subjects on tasimelteon for at least two years in order to gain more insight on the long-term risks, Public Citizen explains.

Public Citizen argues the FDA violated legal standards for drug approval because clinical data submitted by Vanda did not include studies of people who have non-24 sleep-wake disorder but are not blind. Vanda applied to market the drug only to people with the disorder and who are blind. Public Citizen maintains there is no evidence the drug is safe and effective for people who have the disorder and are not blind. Further, Public Citizen says the product labeling should include data about toxic effects that was seen in animal studies, according to the WSJ. Public Citizen asks that the "carcinogenesis," "mutagenesis," and "pregnancy" sections of the prescribing information be updated to indicate risks missing from the current label.

The FDA said the agency will review Public Citizen's petition and respond directly to the organization, the WSJ reports. Dr. Michael Carome, who heads Public Citizen's Health Research Group, said, "The actions taken by the FDA in response to the original mistake in approving [the] erroneous label are unacceptable and deeply disturbing." According to Carome, 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."

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