FDA’s Online Misinformation Plan Draws Medical Industry Concerns

Medical product companies are more equipped to fight online misinformation due to recently revised FDA guidance, but the growth of independent third parties and artificial intelligence present steep hurdles for industry.

The Food and Drug Administration’s draft guidance addressing how medical product manufacturers should respond to false or misleading information on social media is expected to create a clearer path for industry after the agency earlier this year replaced a 2014 version of the guidance.

The draft update sets out an enforcement policy guiding how manufacturers, through “tailored responsive communications,” can address false, inaccurate, or misleading representations about a firm’s approved or cleared medical product created by or disseminated by an independent third party.

According to the guidance, the FDA does not intend to enforce requirements related to promotional labeling and advertising, as well as post-marketing submission of promotional communications, if companies follow its guidelines.

Recent feedback on the draft guidance, though, is urging the agency to consider the rise of artificial intelligence, new market entrants, and the general extent of its enforcement policy. Leading industry groups and legal experts worry the scope of misinformation has rapidly grown since the agency issued its 2014 guidance.

“It’s further acknowledgment of the degree of misinformation that’s out there,” Christopher Campbell, chair of the product liability and mass tort practice at DLA Piper, said about the draft guidance.

“This is a big step in the right direction. It’s just a question of whether it’s going to be enough of a step, because the FDA, like any law regulation, is always behind reality,” Campbell said.

Online promotions and direct-to-consumer advertisements for prescription drugs—particularly for weight loss or gastrointestinal conditions—have increased in recent years on social media platforms such as TikTok, Instagram, and X, formerly known as Twitter.

For decades the FDA has regulated advertising on TV, radio, and in magazines, but has been slow to act, or unclear on its authority, regarding how companies should address online misinformation.

Bloomberg Law in December 2023 published an investigation on the agency’s lack of focus on social media marketing that found the FDA has done little to regulate influencers who may or may not have direct ties to drug manufacturers.

The inaction has drawn the attention of lawmakers. Sens. Dick Durbin (D-Ill.) and Mike Braun (R-Ind.) in September introduced a bill seeking to address the agency’s lack of action. The measure would require the FDA to issue warning letters, followed by fines for noncompliance, to social media influencers and telehealth companies that engage with false and misleading prescription drug promotions.

Growing Misinformation

The FDA’s updated guidance expands the types of misinformation within the scope of the enforcement policy and permits company responses to misinformation regarding an entire class or category of medical products, said Eva Yin, a partner at Wilson Sonsini Goodrich & Rosati’s FDA and regulatory health-care practice.

The agency outlines tailored responsive communications when companies respond to false or misleading statements by independent third parties. This includes being truthful and accurate, scientifically sound, directly relevant and responsive to the identified misinformation, and keeping the response limited to the information necessary to address the identified misinformation.

The FDA says an independent third party is a person or entity that, in communicating about a company’s approved or cleared medical product, is not acting on behalf of the company.

But while the guidance “better reflects the wide scope of internet-based content seen in today’s information age,” it doesn’t sufficiently address AI, the Advanced Medical Technology Association wrote to the FDA.

The association’s comments ask the agency to clarify addressing misinformation or exaggeration aggregated by AI, along with providing additional guidance on addressing impersonations of a company. AdvaMed wrote it has seen independent third parties impersonating a pharmaceutical or device company and its leadership or employees through technological accounts and deep fakes.

“As AI and its adoption expand, it becomes increasingly difficult—or impossible—to address the source that is generating certain information that is exaggerated, inaccurate or misinformation based on the sources used,” AdvaMed wrote.

The leading drug industry group, the Pharmaceutical Research and Manufacturers of America, in its comments raised concerns about the “recent proliferation in new market entrants,” such as compounding pharmacies, telehealth companies, and certain e‐commerce retailers, in the online misinformation battle.

The group is asking the FDA to make clear that an independent third party may refer to another commercial entity, including new categories of market entrants active in the sale and distribution of treatments.

PhRMA also questioned the FDA’s position on casting its recommendations as an enforcement policy given the nature of the online responses to misinformation contemplated by the draft guidance.

“Such communications are far removed from communications that would meet the legal definitions for advertising, labeling, or evidence of intended use, and we are concerned that FDA’s grounding of the guidance in ‘enforcement discretion’ could suggest otherwise,” PhRMA wrote.

The Association for Accessible Medicines—representing the generic drug and biosimilar industry—asked the FDA to expressly state that companies are not required to monitor for and correct independent third-party communications and will not be subject to enforcement action if they choose not to address such communications.

“It opens up a bigger issue that I’m not sure FDA wants to tackle right now,” said Michael H. Hinckle, managing partner at K&L Gates’s Research Triangle Park office. “And that is, exactly when do materials become promotional and therefore within FDA’s jurisdiction?”

Company Implications

Despite the guidance creating a broader path for firms to respond to misinformation, companies are still cautious in their responses as they must abide to FDA rules and regulations, life sciences attorneys say.

Addressing misinformation comes with various liability risks as manufacturers can appear to endorse unapproved uses of its product, or may respond selectively.

“The issues are typically about liability,” said Alan G. Minsk, partner and leader of the food and drug practice at Arnall Golden Gregory LLP. “All of a sudden someone turns this into a promotional opportunity—you might get into false or misleading information.”

Companies also face some limitations in the revised guidance, said James Ravitz, head of the FDA practice at McDermott Will & Emery. This includes the FDA not extending the enforcement policy to company responses to statements describing opinions or value statements about an approved or cleared medical product, and not applying the policy to responses to representations about an individual patient’s experience.

“At the end of the day, these influencers have millions of followers. Their ability to reach a broad public audience is astounding, and they can do it in a moment,” Ravtiz said. “Any tool that a company has to be able to combat misinformation is going to be helpful and welcome.”

But “drug companies are very scared of stepping out of line when it comes to prescription drug promotions, advertising, marketing,” he said.

The FDA, though, clarifies that a 2253 submission is not required for tailored responsive communications consistent with the recommendations in the updated draft guidance.

Submitting promotion materials to the FDA through a 2253 submission can cause delays in responding to quickly disseminated misinformation, said Sonia Nath, chair of Cooley LLP’s global life sciences and health-care regulatory practice group.

“Until you had this guidance, there were still some unknowns regarding how the FDA was going to come out on any of these issues,” Nath said.

“Companies were already grappling with these issues, but I think this will give them some comfort, and it may actually have the impact of having more companies start to address this themselves instead of waiting for FDA to put out a public health notice.”