Will We Soon See the FDA Approve the “One-Click Rule” in Official Guidance? | Pharma Industry Regulation | Scoop.it

Will the FDA's proposed study on links end up allowing the one-click rule for digital pharma marketing? The possibility is there--and that has some marketers hopeful (read “#FDA to Study Space-Limited Communications. Will It Help #Pharma Market Drugs on Twitter & Facebook?”; http://sco.lt/5DbIqf).


The newly proposed study intends to look at whether links in "character-space-limited communications" can be effective and are sufficient to convey important risk information. The hope is that it will address, and possibly settle, an issue that has long been a point of uncertainty for pharma marketing in search and social media.


The so-called one-click rule, which is not an actual rule but just the common way to refer to its use, would allow pharma marketers to use links to an outside website to present safety information, instead of having to put the information within the advertisement. Because risk information tends to be long but the FDA mandates it be contained in the ad, it has meant few branded drug ads in space-limited places like Twitter and search ads.


"If the research is conducted and convinces that public health is protected, that patient safety is honored, and it does prove effective in getting patients the safety information they need, the one-click rule would be an absolute game changer for the industry," Michael Spitz, VP of digital strategy and business development at Klick Health, told FiercePharma.


While one-click link ads don't exist today, many pharma marketers did use what were called "sponsored links" in banner ads until 2009. However, on April 2 of that year, the FDA sent warning letters to 14 drugmakers about 45 branded drugs advising them to cease using the ads with the links because they were in violation of its policy against running advertising without risk information.


The move effectively ended digital pharma marketing's use of one-click links to safety information. The agency indicated earlier this year that social media links would be a topic of research this year.


Mark Senak, a public relations professional and a blogger at Eye on FDA, said via email interview that he thinks the issue is coming up now, in part, because of the impact of social media on healthcare.


"I think FDA was taken by surprise by social media's emergent role in communications, particularly in health communications, and so have had to play catch up," Senak said.