First Letter for 2020

OPDP has issued it's first letter for 2020, this one to Outlook Pharmaceuticals.

This letter incorporates two themes OPDP has addressed in the past: (1) having paid search ads with claims but no fair balance and (2) Having an ad for an ADHD drug without risk of suicide in teenagers.

In 2008 OPDP sent out letters to 4 manufacturers of drugs to treat ADHD.   These letters all had one similar theme: No or limited mention of suicidality risks of these medications, especially in teenagers and the elderly.

In 2009 OPDP sent out letters to 14 companies for having claims in their sponsored ads without any fair balance.   This set out a series of events that led to Google actually getting involved and working with industry to come up with standards for these sponsored pharmaceutical ads.   What wasn't addressed was that companies could partially defeat this objection by OPDP by just putting the same information in the html backbone of their website so that Google and other search engines would be more likely to pull that information up as the search result for that particular drug.  In fact, in the screenshots of the sponsored ads for some of those 14 drugs some of the same claims were present in these so-called "organic" (not sponsored) search results.

OPDP later cited another company for placing similarly structured weblinks within a product website for another drug, again without presenting any fair balance for those drugs.

The most recent letter to Outlook Pharmaceuticals has claims without any fair balance which, in turn, means that they failed to mention anything about the suicide risks of their drug.

It should be noted that in my research over the last several years I have encountered a number of companies, especially those with their first drugs, who use sponsored ad search results to give the indication or drug class of their drug.   In most cases these are just statements or summaries of their indication and DO NOT contain any claim language.   Even some of the larger companies who led the way in removing claim language in their sponsored ads are now, years later, putting those claims in their sponsored ads.

As OPDP has done many times in the past, if they want to refresh industry on a subject they find a relatively to very onerous example of something they have sent letters for in the past and send out another letter or two.

The bottom line here is that paying attention to what OPDP has said not to do, even if it is warning or untitled letters from over a decade ago, is something that can keep you out of trouble.   At the same time, following what larger pharmaceutical companies do and accepting that as industry standard and, therefore, a low-risk practice is a good way to get into trouble with OPDP.