OPDP Letters for Promotion of Investigational Compounds, Part 1

As many know, I have put together a data base for my use that tracks the letters sent by FDA’s Office of Prescription Drug Promotion (OPDP) since 2004 – tracking company, date, indication, product name, type of communications vehicle and type of violation, among other things – which allows me to sort on various fields or combination thereof.  One of the fields tracked is whether or not the communications vehicle involved in a violation was digital or not, which allowed me to produce the white paper in April on that topic.

Recently I had cause to go back and look for any warning or untitled letter sent because of a violation cited by FDA for promotion of an investigational product.  If you have ever wondered what would trigger a letter in this regard, it is a good idea to look back and see what has.  Here is a little overview of letters since 2004:

  • Number. There were a total of 8 letters relating to promotion of an investigational compound, involving 9 different communications vehicles
  • Indication. Interestingly 5 were in Oncology, 1 involved a cosmetic treatment, 1 treatment for ADHD and 1 treating diarrhea;
  • Type of Letter. Only 1 involved a warning letter – the rest were untitled (NOV) letters;
  • Digital or Non-Digital. Another point of interest – nearly all involved digital communications vehicles – 6 were Web pages, 1 was a brochure and 1 involved statements made by spoken word during media interviews (that one involved a clinical investigator)’;
  • Violations. Finally, none of the letters involved any other violation except the promotion of an investigational compound.

What comprises promotion of an investigational new drug?  ”A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.  This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media.  Rather, its intent is to restrict promotional claims of safety of effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”

In my next posting on this topic, I will try to summarize the language and circumstance that the agency cited that prompted the letter.

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4 Responses to OPDP Letters for Promotion of Investigational Compounds, Part 1

  1. Brian Reid says:

    This is brilliant stuff. Looking forward to your next post, but it sounds like the general takeaway is that the agency isn’t slapping wrists over press releases. Which, I hope, will make everyone breathe easier about accurately communicating scientific exchange.

    • Senak says:

      Thanks Brian! You are correct that a press release has not been the subject of one of these letters, at least within the period reviewed (since 2004) however, that doesn’t mean a press release is immune. As OPDP would say, it is not the medium, but the message. There was the example of the clinical investigator who made statements in the context of an interview that were perceived as promotional by the agency. Those quotes, if they had been in a press release, would likely provoke the same outcome. In Part 2 of this, we’ll examine the message more closely.

  2. Rob Wittenberg says:

    Love your blog. I’ve got my own database, too.
    Burzynski Research Institute, Inc. in Oct 2012, was cited for 2 websites (which included 3 embedded press releases) and 2 videos. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM326631.pdf

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