Regulator efforts to control certain types of web ads for drugs are too vague to do any good.
After long being ignored, online ads for drugs are now under regulators’ microscopes. The U.S. Food and Drug Administration unit that regulates pharmaceutical marketing and communications has sent warning letters to 14 major drug companies including Merck and Pfizer, saying certain web ads are “misleading” and fail to disclose possible risks.
The FDA posted the letters from its Division of Drug Marketing and Communications on its website on April 3, a day after releasing them. The letters all deal with “sponsored links,” or the type of ads that are displayed next to search-engine results thanks to matching keywords.
A letter to Bayer, which is representative of letters sent to other companies, takes issue with sponsored links for the company’s erectile dysfunction drug Levitra as well as birth control medications YAZ and Mirena.
“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,” the letter begins. The letter goes on to say that the ads for YAZ and Mirena “inadequately communicate the drugs’ indications” while the Mirena ads “overstate the efficacy of the drug.” The letter concludes that the sponsored links misbrand the drugs, in violation of the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations.
While the particulars for each of the other 13 letters differ, the basic theme is the same: sponsored links are not in compliance because they are “misleading.” The letters says the ads make “representations and/or suggestions” that the FDA division believes are out of compliance, and fail to present the appropriate risk information.
When it comes to the division’s 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 division’s 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 letter to sanofis-aventis is particularly instructive on this point. The document states that promotional materials—other than reminder pieces—that include the drug’s name but don’t include indications or other material about the drug are required to disclose risk and other information. “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 letter says.
The original ad says “PLAVIX Medication Lowers Risks of Future Heart Attack or Stroke from PAD [peripheral artery disease]. See how prescription PLAVIX medication may help patients with recent heart attack, recent stroke, or established P.A.D. at PADfacts.com …”
So, the FDA division is making the point that sponsored links such as these are being considered as “reminder ads” gone wild.
Guidance? What guidance? The division’s 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 in its “Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines” that is already on the books. The material states “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. The division 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 affect 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 the division’s 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 division) tell me they were caught by surprise by these new 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 the 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.
By PETER J. PITTS
Peter J. Pitts is President of the Center for Medicine in the Public Interest, a former FDA Associate Commissioner and Partner/Director of Global Healthcare at Porter Novelli.
Source: The Burrill Report