The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) sent a Warning Letter to Galt Pharmaceuticals LLC regarding its marketing practices for Doral, a drug used to treat insomnia. The letter is in reference to a Galt email sent to healthcare professionals promoting the use of Doral, but which made allegedly false or misleading claims “about the risks associated with and efficacy of Doral,” thus making Doral misbranded. Doral, also known by its generic name quazepam, is a benzodiazepine and schedule IV controlled substance. Doral is contraindicated in patients with known hypersensitivity to benzodiazepines, and in those with concomitant opioid use.
Multiple companies have held the marketing authorization for Doral, with Sciecure Pharma, Inc. being the application holder immediately prior to Galt. In 2014, OPDP sent Sciecure an Untitled Letter for a Doral professional sales aid that “omitted important risk information, contained unsubstantiated superiority claims, and omitted material facts.” OPDP expresses concern in the present Warning Letter that Galt is continuing to promote Doral in “a similarly violative manner” as Sciecure.
Regarding the Galt violative promotional materials, OPDP notes that the email contains numerous claims about the benefits of Doral, but omits warnings and precautions, including those in reference to benzodiazepine withdrawal syndrome. The email also omits warnings about CNS-depressant and daytime impairment effects. In addition, the email fails to warn about anaphylactic reactions, abnormal thinking and behavior changes, the possibility of “sleep driving,” and worsening of depression and suicide ideation. The OPDP acknowledges that the email did include a statement referring providers to the full prescribing information, but indicated that this statement does not mitigate the omission of the risk information from the email.
OPDP also took issue with the claims about the abuse potential of sleep medications. Specifically, the professional email stated that Doral’s “relative likelihood of abuse is considerably lower” than other sleep aids, and made several other similar claims suggesting that Doral has a superior safety profile when compared to similar drugs. In support of this claim, Galt cited a particular study by Griffiths et al. that used an algorithm to calculate the likelihood of abuse and toxicity of various compounds. However, the FDA noted in its 2014 Untitled Letter to Sciencure that the Griffiths study “lacks actual abuse data in human subjects and has not been validated.”
OPDP also cited the Galt email for including false or misleading claims about efficacy, as it suggested that Doral is the only marketed medication indicated for treatment of insomnia “characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.” However, OPDP notes that there are other medications with indications for treating all of these conditions.
OPDP concluded the Warning Letter by requesting that Galt immediately cease introducing misbranded drug into commerce, and to provide a written response to the Warning Letter with a comprehensive plan for corrective messaging. Galt did subsequently provide such a letter to healthcare providers with the corrective messaging, a copy of which is available on its website.
Galt has a unique business model in that they franchise their sales operations, so that individuals or groups buy territories to sell Galt products, but don’t take on liability of ownership of the products.