OPDP issued its first (untitled) letter of 2018, 3 months ahead of the pace in 2017 when the first letter came out in May. The letter was sent to Collegium about their promotion of the extended release opioid product, Xtampza ER.
To summarize, the letter claimed that Collegium did not provide Important Safety Information WITH the claims in a booth panel or in a similar prominence, failed to provide appropriate materials facts (regarding abuse deterrence) and put some material facts in a position on the booth panel that were close to floor level and obscured by a table and chairs. The backdrop of this letter is that Xtampza ER is an opioid product and in light of the opioid epidemic in the country, serious risks of opioids need to be appropriately pointed out when opioid products are promoted.
There is some sentiment in the industry that a promotional booth at a conference is one large promotional piece and that each booth panel does not have to have fair balance if the booth, as a whole, is balanced. This letter seems to indicate that OPDP doesn't see it that way and that Collegium exacerbated the situation by having the fair balance in different prominence than the claims. OPDP also took particular exception to placing material facts near the floor of the exhibit panel, obscured by a table and chairs. Both the disconnect of the Important Safety Information from the claims and the obscuring of the material facts were probably considered by OPDP to be basic mistakes in promotion of a pharmaceutical. Reading between the lines of the letter it appears that OPDP is saying that these types of basic mistakes are even more objectionable when a company is promoting an opioid.
At this point I will interject my own opinion. Every company has key points they want to make in their promotional materials. These are points that in many cases differentiate their product from the competition. Some of those points may be in the gray area of what is allowed based on their product package insert. I think this letter points out that if you want to make those claims you should make sure that the rest of the promotional material is pristine in terms of things that could be construed as violations of the promotional regulations. This letter seems to say to me that OPDP thought Collegium was trying to get every little edge in their promotional claims, in some cases going so far as to do things that appeared to be silly, like putting material facts so low on the booth graphic they almost became footnotes. I think OPDP looks at promotional pieces as a whole. If that is true, trying to gain every little possible edge can create a straw-that-broke-the-camel's back situation compared to just making one or two appropriately balanced claims that fall in that gray area with the rest of the piece being on point relative to the regulations. I could easily be wrong but this is how I feel I have been successful in my career at helping companies create compliant promotional materials that are, at the same time, effective.
In addition to the above, the origin of the letter and the context of OPDP citing previous communications with Collegium are interesting.
1. The letter indicated that the violations were observed by an OPDP representative at a meeting in June, 2017. This shows that even in the new political administration where OPDP regulation may not be as important, OPDP is still going to meetings and looking for promotional violations. Additionally, the lag between when the violation occurred and when the letter issued fits with what I have seen for previous OPDP letters over the years, on average.
2. The letter referenced advisory comments that OPDP had provided to Collegium regarding other promotional materials for Xtampza ER. In those advisory comments OPDP asked Collegium
to modify those materials to correct many of the same issues that OPDP found with the booth panels. This is not the first time OPDP has referenced previous communications in an action letter but it again points out that refusing to heed OPDP advice can increase the risk of an OPDP letter regarding future promotional materials that have the same issues. Bottom line: if you choose to or are compelled to seek advisory comments from OPDP, it is wise to heed those recommendations. Failure to do so can just add more straws to that already weakened camel's back.
None of what I have said above is intended to condemn Collegium's internal review process, what they intended to do or what is done at OPDP. It is just my opinion on how this letter can be an example that can help companies do a better job of creating compliant and effective promotional materials.
