Happy Birthday, Bad Ad! “Paging Dr. Nark” Program Bearing Fruit

In case you didn’t notice, FDA has been busy rolling out “results” of its BadAd program.

FDA launched the BadAd program exactly one year ago -- May 11, 2010 -- encouraging physicians to report pharma marketing and sales shenanigans to FDA. Here’s the FDA letter to healthcare professionals inviting them to participate in the program some have likened to hiring government spies. Here, also, is a presentation from FDA in April 2011 providing an explanation and update on the program. The program, by the way, was created by two former sales representatives with 11 years combined selling experience.

For awhile, we hadn’t seen the BadAd program bear any “fruit.” However, over the past several months, FDA has issued four letters to pharmaceutical companies, making it clear each time that these specific admonitions were a result of BadAd.

Here’s a quick recap and some commentary on the letters, issued to Hill Pharmaceuticals (for a website), Three Rivers (Dear HCP letter), Forest (sales rep verbal statement), and Warner Chilcott (YouTube video) ...

1. Hill Pharmaceuticals – Derma-Smoothe (website)
Dec. 2010 – In this inaugural BadAd letter, FDA cited Hill Pharmaceuticals for violative content on its Derma-Smoothe website. They said several pages on the site were false and misleading “because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product.”

It seemed an extreme example. FDA shared images of Hill's website (below), and if you haven't seen them, now you understand why FDA and anyone else would have an issue with it from both a regulatory and aesthetic viewpoint ...

John Mack features a quote from the president of Hill, and a survey on his blog.

I’d seen this news, but at the time I didn’t think much of BadAd. Then I saw the letters kept coming ...

2. Three Rivers – Infergen (HCP letter)

March 2011 - Kadmon’s Three Rivers Pharmaceuticals received a BadAd letter addressing a company “STATgram” communication for Infergen, a hepatitis C treatment. Infergen’s label carries a black-box warning. The violations included the usual suspects - risk was information minimized or omitted, claims were inflated, and the indication was broadened. These are the typical violations that pharma knows it shouldn’t do, and the letter didn’t particularly stand out as out of the ordinary.

3. Forest Laboratories – Savella (verbal statement)

May 2011 - Forest Labs received a letter last week for misleading claims about its fibromyalgia drug Savella. The letter stated Forest was promoting unapproved uses for the drug, making unsubstantiated superiority and mechanism of action claims and minimizing serious risks associated with Savella. The channel? Words out of a sales reps’ mouth.

This one was the most interesting to me. A physician reported to FDA that what a sales rep said verbally was in violation.

This is actually precisely where BadAd makes a lot sense for FDA, because FDA reviewers certainly cannot monitor every conversation that every sales rep has with a physician. But it does raise a situation of “he said, she said,” doesn’t it? I am not implying the reporting physician is lying. (In my opinion/experience, there’s a pretty good chance the rep was in violation and the physician was just reporting what he/she heard.) But it does raise the question ... Did the rep get a chance to address the situation before the letter was issued publicly? Was something the rep said possibly misinterpreted?

Forest certainly has its own issues with our federal government, including an attempt by FDA to oust their CEO. But I’d be concerned if we see more of these “he said/she said” types of letters. Where will it end?

How does FDA prove there was misbehavior in cases like this? John Mack listened to a recent FDA webinar on BadAd and quoted FDA's response to a similar question:

"We have a very high level of evidence that we require that often includes an affidavit ... and verification as well. So, we do have a very high ... standard of evidence that we require before taking enforcement action." No further details were given.

4. Warner Chilcott – Atelvia (YouTube video)
Announced just this week, Warner Chilcott  got the long arm and heavy hand of the BadAd program in yet another example of sales reps behaving badly (BadAdly?). This one involved a short video on Altevia (their osteoporosis drug) that was posted on YouTube. The video had violations all over the place, including superiority claims, omission of risk and safety, overstatement of efficacy, etc. The kicker? The letter states that the video was "posted by the sales representative on the website YouTube.com under the direction of a Warner Chilcott District Manager."

It looks like FDA caught their first example of bad “home-made promotional materials not submitted to FDA, as they stated was a goal.

Some will see this letter and think it was about YouTube. (FYI, this isn’t the first time FDA issued warnings for YouTube videos.)

This wasn’t about YouTube. It was about rogue reps and district managers making poor choices.

What’s actually most interesting to me about this letter is the physician must have been searching on YouTube for information about Atelvia.

Too bad WC didn’t instead have an approved YouTube page to provide responsible, compliant information in place of the rep’s home-baked video. And perhaps, if they’d had a YouTube presence, company officials would have been aware of the rogue rep video, (that's assuming they weren’t aware until FDA brought it to their attention).

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So that’s four letters in a year. Not bad, BadAd. Not bad. We’ll keep watching and waiting for what the next year may hold.