OPDP says sales aid for insomnia drug omits risk info
OPDP slammed drugmaker Sciecure Pharma with an Untitled Letter, sent on October 29, over a professional sales aid for its insomnia drug Doral it argued is light on fair balance. The sales aid “is misleading because it omits important risk information associated with Doral, contains unsubstantiated superiority claims, and omits material facts," OPDP wrote.
Regulators charged Sciecure with constructing a one-sided argument in the drug's four- page sales aid, saying “[it] includes numerous claims and presentations regarding the benefits of using Doral for the treatment of insomnia, yet omits all of the contraindications…”
OPDP review officers Melina McLawhorn and Mathilda Fienkeng characterized the sales aid's note to “please see full accompanying full prescribing information,” as insufficient, writing that this “does not mitigate the omission of the…risk information. The sales aid misleadingly suggests that Doral is safer than has been demonstrated.”
The drugmaker also omitted material facts regarding the drug's dosage and administration, according to regulators. The sales aid displayed the image of a prescription pad with the following claim, “Doral 15mg @ bedtime,” OPDP cited. Doral's dosage and administration section recommends to start patients at 7.5mg, and to use the lowest effective dose.