Our friends at the FDA Law Blog availed its readership recently of a May 3 webinar where officials from the Division of Drug Marketing, Advertising, and Communications (DDMAC) will devote 30 minutes of their valuable time to talk about “Warning Letters and Untitled Letters issued from January 2011 to April 2011.”  DDMAC has issued only four such letters during this time period, so we thought we would offer up some suggested questions which might help fill up any white noise spaces during the webinar.

By way of background, WLF raised some of these issues with DDMAC nearly five years ago in a Citizen Petition we filed urging a systematic review of how warning and untitled letters are issued so FDA would stop treading on First Amendment rights.  We have yet to receive an answer.

1. Your letters routinely require that company promotional statements be supported by “substantial evidence.” What does that standard require and from what source do you derive your authority to impose it?

DDMAC has developed a policy which essentially prohibits companies from making statements about their products based on anything other than the studies and information supporting FDA’s approval of the drug.  This makes FDA the ultimate arbiter of scientific truth, and keeps health care information out of the hands of patients and doctors in violation of the First Amendment.