At just before 5pm last Friday (April 3), the FDA posted 14 DDMAC warning letters. They can all be found here:
Click Here to Read the Letters
First of all, kudos to the agency for posting them so swiftly. The letters were all released on April 2 and posted on April 3.
DDMAC, timely? What’s wrong with this picture? Or, if you prefer, what’s right?
The next item to consider is the contents of the letters. They all deal with the same topic, “sponsored” Google links.
DDMAC consistent? What’s wrong with this picture? Of, if you prefer …
Consistent because all of the letters not only deal with the same issue of sponsored links, but address them in more or less the same way. Let’s take the letter to Bayer for example:
Here’s how the letter begins:
“The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Levitra, YAZ, and Mirena, but fail to communicate any risk information associated with the use of these drugs. In addition, the sponsored links for YAZ and Mirena inadequately communicate the drugs’ indications, and the sponsored links for Mirena overstate the efficacy of the drug. Furthermore, all of the sponsored links fail to use the required established name. Thus, the sponsored links misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations. See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).”
While the particulars for each of the other 13 letters differ, the basic theme is the same, that the “sponsored links” are not in compliance because they are “misleading” – making “representations and/or suggestions” that DDMAC feels are out of compliance, and fail to present the appropriate risk information.
Now, as all you weathered FDA cowhands know – when it comes to DDMAC letters (and every other piece of FDA communication) – it’s very important to understand what’s in the letter as well as what is not.
These letters are about sponsored links. What does that mean? Sponsored links, as the DDMAC letters illustrate, are those links in the “sponsored” section of a web search (in the case of Google, these are the search results that appear on the upper right hand side of the page). Never more than a few lines, they are teasers. And, not to put too fine a point on it – they are paid for product marketing messages. They are advertisements.
The DDMAC letter to sanofis-aventis is particularly instructive on this point:
“Omission of Risk Information
Promotional materials, other than reminder pieces, which include the name of the drug product but do not include indications or other representations or suggestions relative to the drug product (see 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)), are required to disclose risk and other information about the drug. Such materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the
materials. The sponsored links present the following claims (emphasis in original):
* PLAVIX Medication Lowers Risks of Future Heart Attack or Stroke from PAD. See how prescription PLAVIX medication may help patients with recent heart attack, recent stroke, or established P.A.D. at PADfacts.com … “
So, DDMAC is making the point that sponsored links such as these are being considered as “reminder ads” gone wild.
Guidance? What guidance? DDMAC letters should help companies understand what “in compliance” means. These letters do not. In fact, they make things more muddled. After all, “sponsored links” are by no means a new phenomenon.
Podium policy via Warning Letters is not a replacement for clear and concise guidance.
Okay, so wither “guidance?” Consider some official agency direction that is already on the books:
Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines
Click Here to Read the Report
“Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”
It’s not a leap of faith to understand the implications (and applications) of this relative to the concept of sponsored Google links.
For example, what about the concept of “clicking thorough” to full risk/benefit information? Let’s look to the GSK letter for that one. DDMAC writes:
“We note that these sponsored links contain a link to the products’ websites. However, this is insufficient to mitigate the misleading omission of risk information from these promotional materials.”
Now, here’s where it becomes less clear. How will this impact regulatory perspectives on branded product websites? What about third party websites that have been constructed with grants (unrestricted or otherwise) from interested parties? What about links and websites for devices and diagnostics?
What about predictability?
Well, that’s harder than it sounds because regulators love ambiguity. Ambiguity is power. And that’s particularly true for DDMAC issues that quickly bump up against the First Amendment. That’s why interpretation of FDA actions is such a vibrant cottage industry. Industry, on the other hand, seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA.
My sources inside the agency (but outside of DDMAC) tell me they were caught by surprise by these new DDMAC letters. What does this mean? Does it expose the probability that this important social media issue was not discussed at higher levels? You be the judge – but you can bet they will be now. In fact, I wouldn’t be at all surprised to see this issue discussed at a sitting of the Risk Communications Advisory Committee.
(In fact, it should have been discussed before the letters were sent out in the first place – that’s what advisory committees are for. But that’s just my opinion.)
Here’s something that isn’t opinion -- sending out Warning Letters isn’t guidance – it’s punitive regulatory action. It’s FDA acting tough without putting in the time and brainpower to explain how to address the perceived problem. That’s not what we need. That doesn’t advance the pubic health.
Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself.
Predictability is power in pursuit of the public health.
