As the calendar turned to fall OPDP issued two warning letters.
One letter went to Nalpropion regarding their promotion of Contrave. Several things stood out about this letter:
1. The letter referenced a previous untitled letter from OPDP to Orexigen, the previous NDA holder, regarding the inappropriate promotion of Contrave (2017). A search revealed that Nalpropion purchased most of Orexigen's assets in June, 2018 and the current OPDP letter was issued just a little over two years later. The take home message here is one that has played out previously in a number of OPDP letters when a drug on FDA's radar is sold by a company and the next company may not know of or consider the previous regulatory history of that drug: If you buy the drug from another company you inherit all the regulatory history, including history with OPDP. One thing I think ad/promo professionals should do in cases where their company acquires pharmaceuticals and/or medical devices is to explore the regulatory history like original labeling discussions, FDA reviewer communications, submissions of promotional materials for advisory comments and other FDA communications. In one case I have heard of a company was promoting its drug appropriately and had generated a number of compliant, internally approved promotional materials. When the drug was purchased the purchasing company created a promotional campaign using a number of the claims that were not allowed by the ad/promo review team at the first company. The result was an OPDP letter not long after the new marketing campaign went live. So it might also be a good idea if your company purchases a drug to review the approved promotional materials that were obtained with the drug. If a claim you think was obvious is not present, there is probably a good reason for that.
2. The letter referenced the use of a sponsored weblink to promote Contrave. As with previous OPDP letters on the same subject, this letter pointed to 2 issues:
(a) Sponsored weblinks don't give you much, if any, room for safety information. The letter reiterates that links to that information are NOT sufficient when the ad actually makes claims, as this one does. There are mechanisms for including safety information if you can add fields to the meta data in your web search result to include safety information. Do a Google search for "Enbrel" and if you scroll down the search results you can see an example of how to do this by increasing the number of sub-headings you populate in your search result meta data. I don't know if Nalpropion was offered that opportunity when they purchased the sponsored weblink space but, if it was an option and they had taken that option, they might have avoided an OPDP letter if they had done this as a means to include safety information.
(b) Sponsored weblinks don't give you much text to work with and so it is very easy to overstate safety and/or efficacy by summarizing in order to meet character limitations. Using only the space they used in their sponsored ad there is no way to fit in all the necessary information, including limitations to Contrave's indication to help with weight loss. If Nalpropion had limited their ad to say "See how Contrave can help you with weight loss. Click here (leading to product website)" instead of "Lose 2-4x more weight on average..." they might have avoided this letter as Contrave is approved for use in conjunction with diet and exercise.
Also, as FDA considered this a serious health risk (Warning letter) Nalpropion will have to do corrective advertising. As this was a sponsored weblink and it may not be readily known who saw this ad, it could be quite challenging for Nalpropion to execute this corrective messaging. Also, if you read text OPDP is requiring to be included, it would be difficult to imagine doing it all in a corrective sponsored weblink.
Finally, it is important to note that OPDP said that this letter, in part, was written to Nalpropion because of the FDA's Bad Ad program, which encourages HCPs to report false or misleading drug promotion.
The other letter was addressed to Nephron Pharmaceuticals for their e-mails regarding Budesonide.
The letter said that Nephron had issued e-mails talking about the use of Budesonide to treat Covid-19 symptoms. The issue, of course, is that Budesonide is not indicated for this use.
There are several points about this letter that I want to highlight:
1. I do not see any reference to these e-mails being submitted to OPDP as promotional labeling.
2. The e-mails were apparently sent by the CEO and at least one of the sales reps, making it appear like promoting Budesonide in this way was a corporate strategy, not just a sales rep doing this on their own.
3. The title of the OPDP letter included the language "(COVID Related)"
4. This was also a Bad Ad letter
5. This was also a Warning Letter requiring corrective action by the company.
This is the first OPDP letter I have run across that referred to COVID and I wonder if there was a reason for them to have added this to the title of their warning letter. It is not hard to understand that this could be a sensitive area with FDA and that, potentially, they wanted to address this with companies that are thinking about promoting or actually promoting their drugs as treatments for COVID-19. Similar letters went out during the anthrax mail situation where companies were purporting their medications to treat anthrax and FDA sent out a number of letters saying that these products were not approved for those uses. I was wondering when the first OPDP letter would come out relative to a company promoting its drug as a cure or symptomatic treatment for COVID-19. Now we have it. When you add to the nature of the promotion that no safety information was included, it is interesting to consider why a company would knowingly sent out communications like this.
One thought that crossed my mind was whether these communications were sent out thinking they were covered under the Caronia court case First Amendment rights. The letter would seem to indicate that these claims did not result from any scientific publications but rather the support was from anecdotal reports, some of which were from YouTube videos. It will be interesting to see if any future letters come out about promotion of drugs off-label to treat COVID-19 or if companies will see this letter and not promote their products in this way.
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