Case Detail

Response to DDMAC Warning Letter to Mayne Pharma (USA), Inc.
(Regulatory Proceeding)
On February 10, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Mayne Pharma on February 1 regarding Mayne Pharma's allegedly improper distribution of a promotional mailer regarding M.V.I.-12, a multi-vitamin infusion without Vitamin K. DDMAC alleged that the promotional mailer was false and misleading because it omitted important risk information regarding the drug. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because Mayne Pharma included all necessary risk information in the "brief summary" portion of the advertisement. WLF argued that there is no requirement that a manufacturer repeat that same risk information in the "creative" portion of the advertisement. WLF's response took particular issue with DDMAC's demand that Mayne Pharma disseminate "corrective" promotional messages; WLF noted that FDA lacks statutory authority to require "corrective" messages, and that in any event such a demand violates the First Amendment.
Case Status:
Awaiting FDA Response.
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