Case Detail

Response to DDMAC Warning Letter to Abbott Laboratories
(Regulatory Proceeding)
On July 20, 2005, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to Abbott Laboratories (Abbott) on July 15, 2005 regarding Abbott's allegedly improper promotion of Survanta -- based on Abbott's distribution of a professional direct mailer regarding the drug. Survanta is a drug used to prevent and treat Respiratory Distress Syndrome in premature infants. DDMAC alleged that the direct mailer made unsubstantiated effectiveness claims about the drug and did not sufficiently discloses its risks. WLF's letter to DDMAC alleged that DDMAC's actions were unwarranted because Abbott's effectiveness claims were based on a clinical study whose findings DDMAC has no basis for challenging. WLF also faulted DDMAC for criticizing the prominence of Abbott's risk disclosures in the absence of any FDA guidance regarding the degree of prominence required.
Case Status:
Awaiting response.
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