To put it mildly, enforcement by the Office of Prescription Drug Promotion (OPDP) has been lagging. Warning and Untitled letters from this office numbered in the triple digits twenty years ago. In the past three years, it did not break a dozen. Last year was poised to be the lightest on record, but in December OPDP suddenly came forth with several letters within a month. In the five months since, there has been an overwhelming lack of activity.
Today there was a blip. OPDP posted an Untitled Letter for a DTC Broadcast television advertisement to market a drug with an indication for weight loss. The letter noted that the drug has several warnings and contraindications noted in the label which also includes a boxed warning. In issuing the letter, the only violation that was the subject of the FDA’s enforcement was with regard to the minimization of risk information, which is by and far the most common violation of any cited by the agency when issuing such letters.
There are two issues with respect to risk that are of note. The list of contraindications spans a number of conditions and situations as well as a number of potential adverse reactions. FDA asserted that while contraindication was included as part of the ad, the full spectrum was not present. While there was a statement that the product was not something to be considered for use by everyone as well as one stating that “other side effects may occur” such umbrella statements were not deemed sufficient by the agency to cover the range of risks and contraindications from the label.
In addition, there was an issue with regard to risk presentation. In a March blog posting we looked at DTC advertising and some of the risks associated with it in light of research FDA has undertaken with regard to how risk is being conveyed. Specifically the agency has been on the hunt for anything that might compromise clarity and therefore comprehension on the part of the viewer. Here, among other things, the agency took issue with important risk information being conveyed visually while competing material is being conveyed orally.
The issuance of a letter involving a DTC advertisement is another indication that OPDP is still more focused on traditional communications vehicles than it is emergent digital platforms.
Two questions unrelated to the contents of the letter may naturally arise in the wake of this letter.
First – does the issuance of a letter after a five-month silence indicate a renewed effort at enforcement following the change in leadership at FDA? Since these letters take a good deal of time to generate and the change in hands has occurred only recently, that is doubtful. Also the flurry of activity in December did not indicate more letters forthcoming in their wake.
And secondly – why has OPDP had such a downturn in enforcement? The agency has stated that there are other forms of enforcement activity besides the issuance of letters, but provided no clue as to what that might be. Lacking transparency in that regard, the only quantifiable means we are left with is the issuance of letters. Stay tuned.
