Placed a call yesterday to Thomas W. Abrams, Director, Division of Drug Marketing, Advertising and Communications of the FDA. He returned my call shortly thereafter. I asked him when he was going to make public Purdue Pharma’s reply to the FDA’s 7 page Warning Letter. He very nicely told me that the FDA wouldn’t be making Purdue’s reply public – “It comes under the Freedom of Information Act.” Asked him when “they” would be making it available and he told me that he didn’t know and portions of Purdue’s reply “may not be released.”

Since he was being so accommodating, I asked him why after 10 Warning Letters to Purdue Pharma since 1993 was the FDA not taking action against Purdue Pharma. He then told me proudly that Purdue only received 1 Warning Letter for OxyContin – the one dated January 17, 2003 – the letter to Purdue Pharma requiring the black box insert was not considered a Warning Letter – the other Warning Letters were issued to Purdue Pharma for M.S. Contin – another Schedule II narcotic Purdue markets. Mentioned to him that all 10 Warning Letters to Purdue Pharma from the FDA were issued because of their deceptive marketing practices for a Schedule II narcotic. Asked him how many more Warning Letters would be issued to Purdue Pharma for their marketing before some action was going to be taken against them. Advised him that Purdue Pharma did not seem to be complying with the FDA if they’d gotten 10 warning letters for deceptive marketing. The conversation ended abruptly with Mr. Abrams saying “Thank you very much – good bye.”

Marianne Skolek