Chapter 1: The stakes
To read Chapter 2: A systematic approach, click here; to read Chapter 3: The road foward, click here.
Digital misinformation has been a major concern in health industry circles since the dawn of social media. It took until the dawn of the age of the TikTok health influencer, but the Food and Drug Administration has weighed in in a substantial way.
The agency’s new guidance equips makers of drugs and medical devices with a host of corrective tools. Released earlier this month, it clarifies how pharma and medical device companies should address misinformation appearing on social media that arises from an independent source.
“This could be a difference-maker in terms of correcting the record in the interest of public health,” said GCI Health chief content officer David Chadwick.
Indeed, the 24-page rules of engagement give firms “teeth to push back,” Chadwick noted. Rather than rely on networks’ various options for content moderation, health organizations can take to the comments section of social posts or their own channels to set things straight — without attaching a lot of legalese.
Adoption of these new tools is another matter. Before taking up the cause, pharma companies will likely game out potential impacts. But it’s almost certainly in their best interest, legal experts believe, to shake off their usual conservatism and more actively respond to misinformation sooner rather than later.
The FDA is accepting comments until September 9. One prominent trade group, the Pharmaceutical Research and Manufacturers of America, has announced it intends to submit feedback.
“We support facilitating truthful and non-misleading communication across the healthcare ecosystem about innovative medicines to benefit patient care, including online,” PhRMA spokesman Andrew Powaleny said.
One of two guidances replaced
The update is designed to supplant the decade-old draft guidance for industry on correcting misinformation about drugs and devices on social media. It does not, however, supersede the guidance, also issued by FDA 10 years ago, on presenting risks and benefits of such products on social media platforms that have character limits.
The original guidances were preceded by back-to-back hearings, hosted by the FDA’s promotional watchdog, that were labeled by one pundit as the ”Superbowl of Part 15 Hearings.” The 2009 proceedings featured 69 speakers and, ironically, took place in a conference hall that lacked wireless coverage.
When the guidances finally emerged five years later, they included less detail on what companies could and couldn’t do with social media than many were expecting.
“The misinformation piece was incredibly narrow,” Chadwick recalled. “The ‘space-constrained’ guidelines overall were essentially like, ‘Don’t do anything that you wouldn’t do in a normal, balanced promotional piece or message.’”
Basically, FDA maintained that, whether an ad appeared on social channels or in legacy media, the same regulatory standard would be applied. That means promotion of prescription drugs or medical devices on platforms with character-space limitations must be supported by substantial evidence, with a “fair balance” of information on a product’s benefits and risks.
That also held for addressing online misinformation. A company representative would have to comment on the posted content, or directly contact the individual or entity behind it, referencing the drug’s FDA-approved label and a direct link to that labeling.
The prevailing view was that, at long last, companies knew what FDA would hold them accountable for on the Internet. Neither guideline was ever finalized. What came next was a period during which firms learned, through trial and error, to communicate compliantly on platforms like Facebook, Instagram and YouTube.
‘Late to the game’
Like its predecessors, the newly released draft is something less than a guidebook. The FDA didn’t issue an update on the more expansive topic of online promotion; it merely responded to miscommunication. But the industry nonetheless received it warmly.
That’s largely due to the health influencer phenomenon. These creators, many with no links to drugmakers, have flooded TikTok with videos about their use of Novo Nordisk’s GLP-1 medications Ozempic and Wegovy and Pfizer’s migraine pill Nurtec ODT, pushing certain hashtags to the billion-view mark.
Social media influencers are beholden to the same fair-balance requirements that manufacturers are. Thus far, though, the FDA has taken a hands-off approach to regulating them.
“Lots of misinformation has been spread because we really haven’t seen what the good version looks like,” noted Ryan Krahmer, a former associate director of commercial operations for Bristol Myers Squibb and the founder of Health Influencers United, which connects patient influencers to pharma companies. “The FDA recognizes that they’re late to the game. As it says in the guidance, misinformation poses a risky and harmful practice for public health. This needs to be addressed now.”
Indeed, influencers’ increasing sway over the clinical product world, as well as the worlds of cosmetics and OTC drugs, is “part of the climate that contributed to this new guidance,” said Joanne Hawana, an attorney at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo. While influencers existed when the guidances emerged in 2014, “It wasn’t a career the way it is now,” she added.
Not surprisingly, as the number of influencers has mushroomed, so too has the depth and breadth of dubious online health information. There’s also been a proliferation in the volume of questionable products, from compounded drugs to counterfeit medicines to holistic options whose potential benefits may not be scientifically vetted.
Hawana believes the FDA’s update was probably “more politically than functionally driven,” especially since combating misinformation has been a big plank of agency commissioner Dr. Robert Califf’s post-pandemic agenda. “There were political pressures to make this a priority guidance document, rather than the industry saying, ‘We really need more guidance,’” she said.
The FDA enables anyone to flag pharma advertising that’s false or misleading via its Bad Ad program. The agency’s Office of Prescription Drug Promotion can issue warning letters to companies for unfounded claims, although OPDP has issued relatively few letters for social media-related infractions.
