The Danger of Celebrity

Kim Kardashian's Instagram account joins a long line of celebrity endorsers whose communications have been cited by the FDA.

The following list is definitely incomplete, and I'd appreciate people adding to it in the comments, but this is just a smattering off the top of my head of the celebrity endorsers who have been cited in FDA enforcement:

Magic Johnson in 2009 for Kaletra

Ty Pennington in 2008 for Adderall

Eric Bergoust in 2002 for Tamiflu

Joan Lunden in 2000 for Claritin

Jackie Joyner-Kersee in 1997 for Flovent

Are celebrities dangerous?

Well, they are likely to be featured in high-profile campaigns, especially television advertising, and FDA has always made clear that from a public health perspective, they pay particular attention to high-profile campaigns because their broader reach translates into a greater public health impact.

In addition, celebrities can present a host of issues for otherwise-staid pharmaceutical company employees. There's certainly something thrilling about getting to meet them, and there might be a bit of reticence to tell them exactly what to say. Celebrities themselves are frequently going to have significant experience with endorsing products, and that experience can make them more dangerous. The rules of the road for pharmaceutical promotion are just different, and if a company doesn't have sufficient procedures in place to ensure compliance with scripts and specific language, then it's very easy to start weighing the costs of a reshoot against the risk of FDA enforcement. And once that Rubicon has been crossed, it's very difficult to return.

New Video Lecture Available

The Digital Health Coalition, where I serve as one of the Digital Scholars, has created a new online resource called the Digital Health Coalition Academy. At this online destination, they are providing a series of short videos about topics of interest to people working in the digital health space.

I am pleased that they asked me to create one of the inaugural presentations. I chose to update and slightly expand on the presentation I previously delivered at the FDLI enforcement conference. 

I've previously asked on this blog how much value people get from the slide decks I post on SlideShare when there's no corresponding audio because I sometimes post unaltered decks that were not created as standalone pieces, but were intended to be accompanied by my narrative.

I've also previously declared my intention to start making more video content available, and though this presentation isn't on my YouTube channel, which remains woefully inadequate, I hope the DHC partnership will jump start that process.

Please provide any feedback in the comments or privately about whether you find the presentation useful, especially whether it was significantly more valuable than just the slides alone on SlideShare.

Another Google Search Letter

Just 10 days after issuing its space-limited guidance that included a significant discussion of Google search ads, the Office of Prescription Drug Promotion (OPDP) issued a new letter to Gilead for a a paid search ad.

Here's the violative ad as posted by the FDA:

The infractions don't differ substantially from those cited in the landmark 2009 set of 14 letters for inappropriate paid search campaigns that in many ways began the current emphasis on the unique characteristics of space-limited contexts.

In those 2009 letters, multiple products were cited for three infractions:
1. Failure to use the required established name
2. Omission of risk information
3. Inadequate communication of indication

In addition, one product was cited for overstatement of efficacy.

The new letter includes again the omission of risk information and failure to use the required established name; however, this time the FDA cited a lack of adequate directions for use and a failure to submit under form 2253.

The failure to submit under 2253 is well understood.

The lack of adequate directions for use points to the inclusion of the word "prevention." Viread is currently approved for the treatment but not the prevention of hepatitis B.

As I mentioned previously, I'm working on a new article for the September issue of Regulatory Focus that will revisit Google paid search and pull together everything we have learned from the 2009 enforcement action, subsequent statements from the FDA, and the new draft guidance. This enforcement action definitely adds another piece to that puzzle.

Generics Marketing Receives Another Letter

The Office of Prescription Drug Promotion posted a new letter to its website for the marketing of a generic product (disulfarim tablets) by Alvogen.

Alec Gaffney provides a nice overview of the letter in Regulatory Focus.

Traditionally, generics marketing has not received as much attention from OPDP or its predecessor DDMAC. That has probably been true in large part because there was not as much marketing of generics.

But the post-blockbuster era in pharma meant that lots of drugs with extremely high sales volumes lost their patent exclusivity and generics companies have leapt in to more competitive markets attempting to distinguish themselves and promote their offerings.

FDA has not apparently believed there was any need to provide generics-specific guidance on marketing, as none of the generics guidances provided by the Agency have focused on marketing.

With the recent enforcement actions for generics marketing (in addition to disulfarim, see here, here, and here), and the soon-to-be-approved biosimilars with different possible approvals (interchangeability and biosimilarity), it would be good to hear more from FDA about how it views some of the unique aspects of marketing follow-on products.

OPDP Facebook Regulatory Alert

The Food and Drug Administration's Office of Prescription Drug Promotion released an untitled letter for inappropriate use of Facebook to promote a prescription drug. Digitas Health just released a Regulatory Alert to help other companies marketing prescription products learn from this action and ensure they don't face the same consequences. Here's the alert: http://www.scribd.com/doc/212262834/DH-Regulatory-Alert-OPDP-Issues-First-Letter-for-Facebook-Page-Activity