Case Detail

Response to DDMAC Untitled Letter to Palatin Technologies, Inc.
(Regulatory Proceeding)
On March 8, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to Palatin Technologies, Inc. on February 16 regarding Palatin's allegedly improper promotion of NeutroSpec, a radioactive drug that has proven effective in diagnosing appendicitis. DDMAC alleged that exhibit panels for NeutroSpec, displayed at an April 2005 medical conference, were false and misleading because they omitted important risk information regarding the drug. WLF's letter to DDMAC alleged that DDMAC's actions did not constitute an appropriate use of limited agency resources -- given that the promotional material at issue has not been used in many months and NeutroSpec is no longer being marketed. WLF questioned why DDMAC is only now issuing its letter, 10 months after the display of the exhibit panels in question. WLF's response took particular issue with DDMAC's issuance of an untitled letter in the absence of evidence that NeutroSpec has harmed any patients.
Case Status:
Awaiting FDA Response.
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