Enforcement Update – FDA OPDP Sends Two More Letters

For those who like to keep up on the activity of the Office of Prescription Drug Promotion (OPDP) here is an update. While not shaping up to be another big year of enforcement, there has been a bit of activity lately that merits a look. So far this year, there have only been a total of five enforcement communications. The two most recent were issued in July and August respectively. Like the three before it, the letter issued in July was an Untitled (Notice of Violation/NOV) letter. However, the one issued in August was the first Warning Letter of the year.

The Untitled/NOV Letter. This letter was issued to CooperSurgical for a Direct-to-Consumer (DTC) television advertisement for an intrauterine contraceptive. FDA noted that the agency had received a complaint via the “Bad Ad Program” regarding the advertisement. Use of the contraceptive is associated with a number of contraindications listed in the PI, along with multiple warnings and a list of adverse reactions reported with the use of the product. It was the first letter for this manufacturer.

FDA expressed multiple issues associated with the DTC ad centered on the conveyance and balance between benefit and risk information and the concerns reflect past research performed by FDA regarding perceptions of such information in DTC formats. FDA claimed that while the ad had text that was superimposed with some risk information, it did not disclose all of the risk information from the PI. And in a voice over, the language stated that “If you experience pelvic pain…” rather than communicating that the product is associated with an increased risk of pelvic inflammatory disease.

What is perhaps most interesting was that FDA found that the presentation of risk information – by superimposed text and audio – was undermined by the simultaneous presentation of distracting visuals, scene changes and media which were unrelated to the actual risk information being discussed in the superimposed text. This, FDA said, would complicate the ability of the viewer to discern and understand the risk information. In 2016 FDA completed a study “Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertising Viewing” where one of the findings was that distracting elements during presentation of risk information could impact retention of risk information.

Moreover, FDA said the ad communicated risk information in the visual portion of the ad only, but did not include major side effects and contraindications in the audio. In some cases, unrelated risk information was being portrayed simultaneous to audio information. Finally, FDA took issue that the ad repeatedly stated that the product was free of hormones which, while true, the agency felt that the repeated and emphatic repetition of this fact minimized the risks the product does have in its use.

The Warning Letter. This was issued in August, the first of the year. This letter went to Metuchen Pharmaceuticals for a DTC Print Ad and Display Banners promoting a product treating erectile dysfunction. It was the first letter for this manufacturer. The violations FDA cited were the Lack of Adequate Directions for Use, Misleading Risk Presentation and Misleading Claims on Efficacy. Given the breadth and scope that FDA went into with this Warning Letter, only the highlights will be covered here.

First the risk issues – FDA stated that some of the banner communications conveyed benefit without any risk information about the product. At times, some side effects were included, but not the contraindications or warnings. Likewise the print ad was cited for not stating any contraindications. In short, this stands for the proposition that risk information has to be complete in any conveyance, and presentation of some of the information does not cut it for OPDP.

Next, FDA also cited language used that the product was being termed as “next generation” and that this characterization lent the impression that the product might be safer and more effective than existing treatments.

The agency also took issue with what it deemed was an efficacy claim centered on language that promoted the product as something you could use “whenever you want”. FDA stated that the efficacy of the product was not shown beyond two hours and that dosing was recommended no more than once per day. Therefore the “whenever you want” use implied a window of efficacy beyond the 2 hour time period on the recommended dosing.

Most interesting perhaps was the claim made in the advertisement that using this particular drug allowed for the treatment of erectile dysfunction while at the same time reducing risk of heart failure. The agency said that this suggested that the product was safe for all patients at risk for heart failure and that while there is evidence that the class of product was she for some types of heart disease and people with some types of heart disease were not included in clinical safety and efficacy studies. It is a lesson on how easy it might be for a claim of benefit to stray outside the strict boundaries of the label.

As noted in an earlier posting, along with guidance documents and prior warning and untitled letters, the research agenda executed by OPDP provides some insight and should inform best practices in the development of promotional materials. We are up to five letters this year. We’ll keep watch and report on any activity for the final quarter.

Photo by Goh Rhy Yan on Unsplash

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