> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Galt Marketing Email Gets FDA Warning
- URL: https://www.fdaweb.com/galt-marketing-email-gets-fda-warning/
- Published: 2019-09-27T12:00:00.000Z
- Updated: 2026-09-15T01:52:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145116

An email distribution by Galt Pharmaceuticals to health professionals has drawn an [FDA Warning Letter](https://www.fda.gov/media/131111/download?ref=fdaweb.com) on insomnia drug Doral (quazepam) tablets because it made misleading claims and representations about the drug’s risks. The CDER Office of Prescription Drug Promotion (OPDP) letter charged that the Doral email included numerous claims and presentations about the drug’s benefits, but it completely omitted warnings and precautions about benzodiazepine withdrawal syndrome. Additionally, while the email presented some risk information about the serious risks associated with Doral, it omitted certain material information pertaining to the risks. Specifically, the email failed to disclose information from the Warnings and Precautions, CNS-Depressant Effects and Daytime Impairment sections of the \[package insert\] that patients should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness...,” it said

The OPDP letter acknowledged that the email included the statement: “For a full list of warnings and precautions, please refer to the full prescribing information.” However, it said that this disclosure “does not mitigate the omission of the aforementioned risk information from the email. By omitting this material information related to serious risks associated with the drug, the email, similar to the professional sales aid at issue in the 2014 Untitled Letter, misleadingly suggests that Doral is safer than has been demonstrated.”

OPDP’s letter also told Galt to immediately stop using the email and other materials with similar violations. Because the violations it cited were serious and repeated, OPDP requested that the company submit a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the violative issues to those who received the email distribution.