Avanthi OPDP Letter

Just as you might have thought that the OPDP calendar year was going to go out like a lamb, the Office sent out their 4th letter (3rd warning letter) of the year, this one to Avanthi for their promotion of Lomaira (TM) at two meetings in early 2017.   Lomaira is manufactured by KVK Tech which has the same address as Avanthi Inc.   The relationship appears complicated as each of Avanthi and KVK Tech have separate ANDAs for this drug and it is unclear if KVK Tech was involved in the creation or use of these graphics, as well.

Warning Letter

Promotional material

The letter cites Avanthi for not providing ANY risk information on this graphic used at these two meetings.   It is not clear if these graphics are from booth panels for Lomaira for an Avanthi/KVK Tech booth at these meetings but it is reasonable to assume that this is the case. The company is also cited for not being clear about what Lomaira was indicated for, as the indication limited Lomaira to short term use in patients with certain body mass indices and/or co-morbid conditions.  As a warning letter it asked Avanthi to provide corrective information to all those who may have seen the booth panels which, for two national meetings of this size, would be quite extensive and expensive remediation. 

Given what is presented in the letter, it appears OPDP is standing on strong ground in citing Avanthi.  Clearly, limitations of the product are not captured on the graphic cited by OPDP and no ISI is presented on the graphic nor is the language on the graphic moderated in any way to take into account the approved product labeling. 

Interestingly, however, is that there is a product website for HCPs, https://www.lomaira.com/hcp/, which contains the same graphic but has the Important Safety Information (ISI) and other balancing information on the same webpage.  OPDP did not cite any of the information on this product website nor on a separate website, https://lomairaonline.com/ which may or may not be associated with Avanthi or KVK Tech but contains the same graphic and has claims about Lomaira but no safety information.  The boilerplate language in the OPDP letter covers OPDP from having to mention other uses of the supposed violative material but, generally, companies receiving OPDP letters immediately remove violative material from all sources following receipt of such a letter.  In this case, KVK Tech chose NOT to remove the graphic from its product website, possibly because the website contains the balancing information that the graphic at these conventions didn't have.   That is, they may have felt that the graphic was OK if the appropriate balancing information was presented in prominence similar to the graphic.

An interesting point that is worth consideration is whether Avanthi/KVK Tech had a booth at these meetings.  If not and this graphic was just presented in some rotating/flashing billboard in the main hall then OPDP's points are well-taken.  However, if this graphic was a booth panel at a product promotional booth at these meetings then the question remains why was there not ISI or balancing language associated with this graphic?  I have seen companies in the past use, for whatever reason, free standing ISI placards next to promotional graphics in a booth.  While I have seen these used they can be problematic as someone may forget to bring them or place them appropriately, they may be moved away from the graphic for some reason or they even may be obscured by desks, plants, etc., the latter having been cited before in OPDP letters.  Also, I have seen (very rarely) booths where the ISI is not on every booth graphic, which made me think that the company felt that the booth was one big promotional material and that they only needed to have ISI visible in the same prominence in some places in the booth to cover the claims they made throughout the booth. This would assume, of course, that the booth was always used in tact at all meetings.   It would be interesting if, indeed, these were booth graphics, to see what the overall layout of the booth was like and what the thinking of Avanthi/KVK Tech was in how they set up the booth and whether they had ISI. 

It would also be interesting to see who owns www.lomairaonline.com as, from the OPDP letter, one might have expected that website to be changed due to the OPDP letter and the lack of ISI/fair balance on that website.