Response to DDMAC Warning Letter to Reliant Pharmaceuticals
- Case Date: 9/20/2006
- Project Name: Health Care Project
On September 20, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Reliant Pharmaceuticals, Inc. on September 14 regarding Reliant's allegedly improper promotion of Rythmol. DDMAC alleged that two promotional pieces for Rythmol were false and misleading because they failed to provide information regarding risks associated with use of Rythmol and improperly broadened the product's indicated uses. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate, in large part because Reliant's promotional material was not directed at anyone in a position to purchase Rythmol (i.e., patients or their doctors). Rather, the pieces were directed solely at pharmacists. WLF's response also noted that DDMAC was wrong in asserting that Reliant failed to disclose risk information; all the risk information cited by DDMAC was included in the FDA-approved prescribing information that accompanied the promotional materials.
|Awaiting FDA Response.|
More Information and Downloads:
Press Release: WLF Calls on DDMAC to Withdraw Warning Letter on Rythmol