Back when the Office of Prescription Drug Promotion (OPDP) issued regulatory action letters on a regular basis (either Warning Letters or Untitled Letters) regarding what the agency saw as infractions in the course of promotional speech, I would post a quarterly summary. While guidance documents provide contour, warning and untitled letters add body to what is known about some of the boundary lines for product promotion.
In the past, many years often saw robust enforcement with the issuance of scores of letters a year. But last year, there were so few letters (nine total) that a quarterly summary was pointless. Rather a single summary provided an overview of the letters that had been issues during the entire year. As you can see from the chart below, enforcement has dropped off dramatically.
This year is no better. This past quarter, OPDP issued a grand total of two letters, maintaining the pace of last year which also marked a record low in annual enforcement. As one can see, in 1998 the office issued over 150 letters. In 2010 it had dropped considerably to about one-third of that with 52. In 2014 and 2015, the number issued was only 9. And so far in 2016, after four and a half months, there are only 2.
The drop in enforcement naturally raises questions. Has industry gotten really really good with compliance? Has OPDP lost interest? In articles from January 2016 on the topic – here and here, FDA was quoted as saying that OPDP was using a “risk-based approach to carefully allocate its resources among these activities to have the greatest beneficial public health impact.” Furthermore an agency spokesperson wrote that “it is apparent that one cannot get a complete picture of OPDP’s program area by looking at a snapshot of time for enforcement letters.” Finally, the agency spokesperson stated that merely looking at one year “does not take into account the work that OPDP does on the other priorities to assist companies with compliance.”
That explanation may raise more questions than it answers. What is the “risk-based approach” and where is the activity that has the greatest public health impact? Is this to imply that other activities beyond enforcement may yield greater benefit? If so, in the interests of transparency, would we not be entitled to know what they are? And as to not getting a complete picture of OPDP’s program with a snapshot – two and a half years of data is hardly a snapshot – it is more like a real landscape portrait.
What that picture, combined with the scant information offered by OPDP’s spokesperson, is that enforcement appears to be a lower priority than in the past – or takes up resources needed elsewhere. Which is fine, but somewhere – in FDA-Track perhaps – we should get to know what they are.