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.
2. What is your legal basis for requiring targets of warning and untitled letters to engage in corrective speech?
In a January 4, 2011 warning letter, FDA required the company to “include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter.” This is another policy DDMAC has developed and consistently applied through its warning letters. In the January 4 letter, as in every other instance we’ve seen in our years of tracking DDMAC, the agency cited no authority for such a request.
3. Has DDMAC ever analyzed the impact of mandating double disclosure of risk information?
DDMAC letters routinely demand that full risk information about a promoted drug appear directly in conjunction with any references to the product and its use. For instance, last year in an untitled letter sent to Novartis, DDMAC objected to the company’s use of a “widget” on Facebook which included a hyperlink to the FDA-required risk information. DDMAC asserted the hyperlink was insufficient. DDMAC’s policy is inconsistent with the First Amendment, FDA’s own regulations, and FDA’s recognition in other contexts that excessive warnings can lead to information overload and consumers’ ignoring all warnings.
4. When will DDMAC issue guidance on the sharing of health care information through social media?
We’ve spoken out several times here at The Legal Pulse on FDA’s continued foot-dragging on social media guidance, and surely someone will ask this question during the half-hour webinar. No doubt, DDMAC will refer to its April 1 statement that “we’re still working on it” and move on to the next question. Everyone with an interest in bringing health care communication into the 21st century should ask FDA this question every chance they get.
5. When will FDA be issuing a report on how it has considered and implemented responses to its 2002 “Request for Comment on First Amendment Issues?”
Of course, we don’t expect an answer to this, but it’s been nine years and FDA’s respect for the First Amendment hasn’t improved much, if at all.