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Case Detail


Response to DDMAC Untitled Letter to Scios
(Regulatory Proceeding)
On November 15, 2007, WLF called on DDMAC to withdraw a letter sent to Scios Inc. regarding Scios's allegedly improper promotion of Natrecor. DDMAC alleged that a mouse pad and pen containing the Natrecor name improperly omitted risk information and did not qualify as "reminder labeling" (which is exempt from the risk-disclosure requirement). WLF responded that DDMAC failed to demonstrate that Scios had actually communicated any specific uses for Natrecor. The material included a picture of a seriously ill hospital patient partially submerged in water. DDMAC alleged that the picture conveyed to readers that Natrecor was indicated for treatment of congestive heart failure; it argued that because the mouse pad and pen disclosed Natrecor's approved use, Scios was required to list all risk information. WLF responded that DDMAC, before concluding that an ad conveys information about a drug's approved use, must gather some evidence to support that conclusion, such as consumer survey data.
Case Status:
Awaiting FDA response.
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