The FDA sent a warning letter to a small Atlanta-based drugmaker for sending an email to physicians with information about a pill that appeared to intentionally omit that it was a controlled substance.
The letter, dated Sept. 13, said Galt Pharmaceuticals' email made numerous mentions about the benefits of its Doral insomnia pill but failed to include a warning about the withdrawal syndrome associated with benzodiazepines like Doral, which is a Schedule IV controlled substance.
"It appears that Galt is intentionally attempting to promote Doral as a non-controlled product that is safer than over-the-counter medication," the FDA wrote in its letter. It added that the email is "extremely concerning from a public health perspective."
The email also claimed that Doral is the only marketed insomnia medication that addresses the three main components of the sleep disorder, but the FDA noted that claim is false as there are other medicines that combat all three.
Galt told STAT it submitted the promotional materials to the FDA Office of Prescription Drug Promotion for review more than a year ago and immediately withdrew the materials after receiving the letter.
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