This is BAD news for all us who have been waiting since November 2009 for the FDA to issues specific guidelines for use of the Internet and social media in promoting Rx drugs.
In its proposal (find my highlighted, annotated pdf version here), the FDA states:
"This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development [my emphasis]."While it's interesting that the FDA now admits original regulations are not adequate in the "shifting dynamic" of today's Internet communication channels, FDA is essentially TABLING Internet guidance by proposing these studies. It's a classic bureaucratic delaying maneuver!
The first leg of the delay will be the 60 days beginning today necessary for the FDA to collect comments to its proposal via the Federal Register page linked to above. Then, FDA will have to review all comments regarding this proposal. Then, if FDA is not seriously challenged on the need for such studies (IS THERE REALLY A NEED?), it will implement the studies. After that it may or may not publish the results of the studies and Tom Abrams will go around the industry conference circuit presenting the results of the study while promising "to have these guidances out as soon as possible."
Enough studies and hearings already!
I urge all who are interested to submit comments to the docket (here) and tell the FDA that these studies are NOT needed and that it should get off its ass and provide the industry with useful guidance.
P.S. Also, tell FDA it's time for Abrams to retire! (see "Is It Time for Abrams to Leave?").
Agreed. Just tell us what they want to do, have public comment period, tweak, then DO it.
ReplyDeleteWe asked on Shrink Rap if DTC advertising should be continued or discontinued. 45% said discontinue. 13% said continue. 6% indicated no opinion. (The balance did not answer this part.) I was surprised to see so many saying to end DTC.
I don't know, John. I would rather see the FDA keep their nose out of it than implement some ridiculously unworkable policy. That said, if they modeled their future policy off of some of the other government policies already in existence, that would be ok. It does make them look pretty silly to take so long about it, but I don't want to force them if they are feeling hesitant.
ReplyDeleteDear Perplexity,
ReplyDeleteI think everyone would agree that it would be better for the FDA to do nothing than to "implement some ridiculously unworkable policy."
There may, however, be ANOTHER reason for FDA's delay in issuing guidance. See my post: "How FDA, in Cahoots with DOJ, Brought Google Down" (http://bit.ly/GOOG14)