Consumer watchdog highlights FDA failures

Consumer watchdog Public Citizen has criticised the FDA for incorrectly expanding the use of Vanda Pharma’s sleep disorder drug Hetlioz – and not correcting its mistake.

The FDA has previously admitted that it made an error with an initial approval letter for the firm’s drug early last year, and now the consumer advocacy group is advising the agency needs to work harder to make amends.

The FDA approved Hetlioz (tasimelteon) in January last year to treat Non-24-hour sleep-wake disorder in blind patients. However, that is not what was put on the drug’s label, which says it is indicated for use in patients with Non-24, not blind patients with Non-24.

By accidentally omitting the restriction Public Citizen says the FDA has opened the door for use of the drug in a wide range of sleep disorder in non-blind patients.

“The FDA has violated the legal standard required for drug approval. The FDA’s actions in response to the original mistake in approving tasimelteon’s erroneous label are unacceptable and deeply disturbing,” says Dr Michael Carome, director of Public Citizen’s Health Research Group.

“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. It is time the FDA fixes the errors and explains its actions surrounding this approval.”

It also notes that the FDA omitted from the label some evidence of harmful effects, including carcinogenic and reproductive toxicity findings, seen in the animal studies conducted before approval.

An FDA pharmacology reviewer noted these findings, but felt that because tasimelteon was to be targeted to the limited population of totally blind patients, the toxicities would not preclude approval as long as they were ‘fully disclosed in the label’, which they were not adds Public Citizen.

Speaking to Reuters an FDA spokeswoman said that there are circumstances in which the agency can approve a med for an unstudied group – under a rule allowing approval based on animal data, for example.

But she did not say whether or not the FDA had done so to authorise use of Hetlioz in patients who aren’t blind.

The consumer watchdog is now submitting a public records request seeking all documents related to the FDA’s actions in the matter, including all documentation of pertinent communications with Vanda.

Brett Wells

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