The FDA has already admitted that it made a mistake with its initial approval letter for Vanda Pharmaceuticals' sleep disorder drug early last year, a consumer advocacy group says. And now, that group is demanding the agency do a better job fixing it.
Public Citizen is taking issue with the label for Hetlioz, which now reads that the med is indicated for use in patients with non-24-hour sleep-wake disorder. That label was supposed to restrict use to blind patients with non-24, and by accidentally omitting the restriction, the FDA opened the door for use of the drug in a wide range of sleep disorder in nonblind patients, it says.
"We are requesting the re-insertion of the phrase 'in blind patients without light perception' to the 'Indications and Usage' section," the organization wrote in a Thursday petition.
The agency did acknowledge that slip, Public Citizen notes, in a letter that appears to have been issued sometime after the therapy's go-ahead. But instead of requiring Vanda to change Hetlioz's label, it modified the treatment's approved use to "match the one found in the erroneous label," making it available to a patient population in which Vanda hadn't studied the drug.
"Rather than take appropriate action by simply correcting the label, the FDA compounded its original mistake," Public Citizen wrote.
As FDA spokeswoman Sandy Walsh told Reuters, 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 didn't say whether or not the FDA had done so to authorize use of Hetlioz in patients who aren't blind.
The FDA green-lighted Hetlioz under its orphan drug pathway, the news service points out, which offers incentives to drugmakers who develop treatments for diseases that affect fewer than 200,000 people. Non-24 disorder afflicts about 100,000 blind patients, the U.S. regulators estimate.
Hetlioz raked in sales of $12.8 million in 2014, helping Vanda post a 40.25% profit margin for the year--good for No.10 among all drugmakers.
Special Report: Top 20 orphan drugs by 2018