For some time there has been speculation that enforcement at FDA is up. But it should be noted that regulatory action letters come from several different parts of the agency and encompass much more than promotional communications.
For our purposes, it is the letters sent from the Office of Prescription Drug Promotion (OPDP) (formerly the Division of Drug Marketing, Advertising and Communications (DDMAC)), that are of most interest. Yes, DDMAC has been elevated to an “office” from a “division”. This probably has significance inside the agency. Outside, perhaps not so much.
Traditionally here at Eye on FDA, enforcement actions are tracked on a quarterly basis and compared to years gone by. One can readily see that from the long-term, the number of enforcement letters has dropped dramatically since last years of the Clinton Administration. During the Bush years, enforcement slowed to a trickle by comparison.
In the past few years, there has been a slight uptake, though the anomaly exists in 2009 when there were 14 letters issued in a single day for paid search ads. In 2010, there seemed to be a genuine increase in enforcement as reflected through the issuance of Warning Letters and Notice of Violation letters regarding medical product marketing. Still, the level did not approach the Clinton-era years – even when the agency decided to share its regulatory enforcement duties with the medical profession by introducing its “Bad-Ad” program launched in May 2010 (see Eye on FDA “Mad Doctors! FDA Deputizes Docs to do DDMAC Ad Reviews“). The agency even issued a report at the end of the year to tote its successes.
Still, even with the net cast wider, enforcement is on a downward trend for the year, with 21 letters issued during the first three quarters of this year (though more are still possible as there is often a lag time of several days before the agency posts the letters to the Web site). Annualizing the current rate would mean 28 letters for the year – back down to levels seen in the 00′s (before docs were doing ad reviews). Such a slowed down rate implies that industry has gotten increasingly adept at marketing within regulatory parameters leading one to the conclusion that perhaps DDMAC (now OPDP) will at last have time to get around to producing guidance on the Internet and social media, in the works for so long and so long overdue.