Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 08 July 2014 | By Alexander Gaffney, RAC •
Less than a month after the US Food and Drug Administration (FDA) first unveiled its long-awaited social media guidance documents, the agency has chided Gilead Sciences for its misuse of a "text-limited" Internet platform covered by its guidance documents, Google Sitelinks.
In July 2014, FDA released two guidance documents covering the use of social media. One of those documents, Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, covers the use of social media channels like Twitter and Facebook, which limit the space sponsors can use to describe a product using text. Twitter, for example, only allows for the use of 140 characters.
But the guidance also includes extensive mention of another, non-social Internet platform: Google advertising, which is also limited in its space for text.
FDA said all Google ads, and specifically those on Google's "Sitelink" platform, would have to include the brand name of the drug, the website for the drug, and an "accurate and non-misleading" statement about the product that is a "material" fact.
The following example is given:
The important part, FDA said, is that the advertisement accurately conveys the drug's approved indication, as well as its major risks and links to where consumers can find the complete listing of all risks.
In FDA's Untitled Letter* to Gilead, the agency claims that a Google advertisement run by the company failed to include sufficient information, misrepresenting its efficacy and safety.
The ad appeared to regulars as follows:
Hepatitis B Prevention – viread.comwww.viread.com/Treating HBV Looking for A Hep B Treatment Option? Click to Learn More!
Hepatitis B Prevention – viread.com
Looking for A Hep B Treatment Option? Click to Learn More!
FDA's letter to Gilead takes issue with the advertisement in two ways.
First, FDA takes issue with the third line of the advertisement, which it says is misleading. Viread, FDA notes, is approved to treat Hepatitis B—not prevent it. "Information sufficient to demonstrate that Viread is safe and effective for this new intended use has not been submitted to FDA in an application," the agency writes.
But the second is perhaps more interesting. FDA notes that Gilead has omitted all risk information from the advertisement, leaving it majorly unbalanced.
"By omitting the serious risks associated with the drug, including the Boxed Warning regarding fatal cases of lactic acidosis and severe hepatomegaly with steatosis and post treatment exacerbation of hepatitis, the sponsored link misleadingly suggests that Viread is safer than has been demonstrated," FDA wrote in the letter.
In addition, FDA also claimed that Gilead had failed to include the drug's established name, and had further failed to submit the advertisement using Form FDA-2253.
But as Dale Cooke of Digitas Health has explained, companies like Gilead may not be—or not always be—to blame in such cases.
In its guidance document, "FDA got sitelinks wrong," Cooke wrote in a blog posting last week. "I don't mean that I disagree about the FDA's view on the use of sitelinks. I mean they don't understand the technology, and what they say in the guidance demonstrates that."
The problem, Cooke wrote, is that Google doesn't always show the "sitelinks" below the first three lines of the advertisement, and companies don't have any assurance as to whether Google will or will not do so.
As Cooke notes, even if the company has included all of the required information, Google might still truncate the advertisement to the first three lines, causing it to run afoul of FDA's guidance document.
But that's not the only problem, Cooke wrote. "Further compounding the problems with the FDA's example is that the order and number of sitelinks provided varies without complete control by the advertiser. So, if all four sitelinks were not provided, there's a chance (based on FDA's guidance) that the advertiser might not be complying the fair balance requirement because FDA might deem it necessary to provide ALL four sitelinks to meet that requirement."
In fact, Cooke concluded, there's a good chance that the advertisement might never be seen properly on mobile devices, which tend to include less information than desktop equivalents.
The Gilead advertisement, then, appears to be an early indication that Cooke's early warning has proved prescient indeed.
*An Untitled Letter differs from a Warning Letter in that FDA does not threaten to take enforcement action against a company, but rather requests that the company cease using the method to market its products.
FDA Untitled Letter
Tags: Google, Google Sitelinks, OPDP, Office of Prescription Drug Promotion, Untitled Letter, Gilead