It has been widely reported that as far as the FDA is concerned it's the message not the medium when it comes to regulating pharmaceutical use of the Internet (see, for example, "A Conversation with the FDA Associate Commissioner for Public Affairs"). This is turning out not to be entirely accurate.
In 14 recent warning letters, FDA challenged the conventional wisdom of consultants to the drug industry about application of the so-called "one-click rule" to Google Adwords. Clicking is unique to messages delivered via the Internet or other interactive media.
The "one-click rule" states it's OK on an Rx product Web site to merely provide a link to the package insert or brief summary. The "rule" was an interpretation of FDA thinking by consultants to the drug industry and was never something the FDA ever claimed as a rule it would use to regulate drug information on the Internet. When I challenged the existence of any such rule, these consultants backed off and called it "received precedence" rather than a rule (see "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!").
With these additional FDA letters there is much more "received precedence" to indicate that the rule or whatever does NOT apply to Google Adwords (see "The 'One-Click Rule': Rant or No Rant?" for more on that).
The Wall Street Journal reported that "The Food and Drug Administration warned 14 major pharmaceutical companies about brief Internet ads that accompany searches on Google and other search engines, saying the ads were misleading because they didn't include risk information." (See "FDA Warns Drug Firms Over Internet Ads").
The ads in question were similar to this Lunesta Google Adword that I first talked about in 2006 with my infamous "Girl from Google" post (see ad below). Google actually advised their pharma clients to create such ads.
In my 2006 blog post, I warned pharmaceutical marketers to be wary about using such tactics and called these ads "bAdwords."
My argument was simply that an AdWord could be said to comply with the one-click "rule" only if within the AdWord text there was a direct link to the package insert (PI) or brief summary. In most Adwords there is a link to the product Web site where the consumer would have to click on a second link to get to the PI. I didn't think two clicks would pass muster with the FDA. After 2 and half years I am proven correct.
One FDA letter went to Biogen Idec Inc. over its multiple sclerosis drug Tysabri (find letter here). "Biogen's ad includes a link to the Web site for the drug," said the WSJ article, "which does contain the relevant risk information. The FDA said the link 'does not mitigate the misleading omission of risk information from these promotional materials.'" See violative Tysabi Adwords below. On the left is the sample provided by FDA. On the right is the one I just found myself.
You can see how easy it is for pharmaceutical marketers to follow bad advice from consultants in the absence of CLEAR GUIDELINES from the FDA. Instead of regulating through "received precedence" the FDA should follow common regulatory practice and issue PUBLIC guidance on the use of the Internet for promoting drugs and devices.
BTW, I HAVE ONE BIG QUESTION. WHY DID IT TAKE THE FDA THIS LONG TO GO AFTER VIOLATIVE ADWORDS WHEN I WARNED THEM ABOUT THIS IN AS FAR BACK AS 2006? IMHO, with the new administration, all the FDA "chickens" who "left the coop" so to speak under Bush's lackeys are coming home to roost!
How the FDA develops this guidance is as important as the guidance itself!
To help determine what the best procedure is, I have developed a survey that presents several different procedures the FDA could use to develop guidance for the use of the Internet and specifically social media for the promotion of drugs and other medical products it regulates.
The options are:
- Before issuing and draft guidance, FDA should convene a public hearing in which ALL the stakeholders can put on record their suggestions and concerns.
- FDA should consult privately with drug companies and then issue draft guidance open for public comments according to normal rulemaking procedures.
- FDA, without ANY prior consultation with drug companies, should issue draft guidance open for public (including industry) comments as per normal rulemaking procedure.
- If FDA solicits public comments -- no matter in what fashion -- it should publish ALL the comments it receives.
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