Where the oversight? Senators urge FDA to fix ‘gaping holes’ in social media drug ads

The U.S. Food and Drug Administration is under pressure to boost oversight of online prescription drug promotions amid the rise of social media influencers and their potential to convey misinformation to vulnerable patients and impressionable teens.

Whether demands from some in the medical community and in Congress will spur new FDA guidance and greater enforcement, FDA-regulated companies should consider reviewing their policies and practices pertaining to influencers they engage, attorneys in the field say.

That includes ensuring that influencers adequately disclose the risks of a drug or biologic, said Nathan Downing, a senior attorney at Stillwater, Minnesota-based Gardner Law.

Downing said companies might want to evaluate whether engaging a social media influencer is even appropriate in the first place.

“Sometimes I say that, for a certain drug, social media might not be for you,” Downing said.

These may include drugs with so-called black box warnings—drugs the FDA deems of highest risk for serious adverse effects or death.

The potential for a social media star to run afoul of long-standing FDA guidelines on drug promotion isn’t new. For years, many influencers have pushed the limits on the agency’s requirement that any promotion be “truthful, balanced and accurately communicated.”

For example, in 2015, then-pregnant Kim Kardashian promoted on Instagram the morning sickness prescription drug Diclegis. She told her millions of followers she felt better since taking the drug, adding, “It’s been studied and there was no increased risk to the baby.”

Immediately, the FDA fired off a warning letter to the drug’s maker, Duchesnay Inc., decrying that the celebrity’s post failed to convey the drug’s risks and demanding the company “immediately cease such misbranding.”

But such swift and forceful responses by the FDA are too few and far between for U.S. Sens. Dick Durbin, D-Illinois, and Mike Braun, R-Indiana.

In February they wrote to FDA Commissioner Robert Califf, citing a dramatic rise in the use of social media and an “alarming proliferation of dangerous and misleading content” promoting prescription drugs and “gaping holes in the FDA’s oversight.”

They said that since 2017 only seven of the FDA’s publicly available warning letters and untitled letters, which flag less serious violations, relate to social media content.

An FDA spokeswoman said the agency has issued 21 untitled letters and 11 warning letters for false or misleading promotional communications for prescription drugs since 2019.

For example, in 2022, the FDA sent a missive to Eli Lilly and Co. over an Instagram post for the company’s blood-sugar-lowering drug Trulicity, alleging the promotion had essentially misbranded the medication.

The video portion of the Instagram message said Trulicity can lower hemoglobin A1C with diet and exercise, but failed to convey the medicine’s FDA-approved indication was for adults with type 2 diabetes.

It also left out other limitations, including that Trulicity is not a substitute for insulin and not for use in people with type 1 diabetes. In addition, the FDA said the fast-scrolling text was hard to read and that video images and music distracted and confused viewers.

But the senators complain that too many instances go unchecked.

“Unfortunately, it appears there are gaping holes in the FDA’s oversight of DTC (direct-to-consumer) promotions that are being exploited on social media at the expense of children and patients,” stated the letter, which demanded answers to 12 questions.

Among these were whether the FDA would commit to updating its 2014 prescription drug promotion guidance document to reflect the current nature of social media use.

The senators also noted that the Federal Trade Commission recently issued broad industry guidelines for social media influencers, including clear and conspicuous disclosure of the connection between the marketer and endorser of a product.

“Please identify what additional actions, collaborations or information from the FTC would further assist the FDA in this regard,” Durbin and Braun asked.

Asked recently whether the senator plans additional action, a spokeswoman for Durbin said there was nothing new to mention.

“I think the industry would like more clarity from the FDA on what exactly its position is on its authority over social media,” said Mahnu Davar, a partner at Arnold & Porter Kaye Scholer and co-chair of its life sciences and health care regulatory practice.

It isn’t that the agency has not been engaged on direct-to-consumer advertising. For example, late last year it implemented a final rule and related guidance establishing standards for Direct-to-Consumer TV and Radio Prescription Drug Advertising.

And last June the FDA published final guidance on “Presenting Quantitative Efficacy and Risk Information in Direct-to Consumer Promotional Labeling and Advertisements.”

That guidance offers companies clearer ways to express risks or positive results to consumers, such as “one out of 10 patients” and using the same numerical format throughout a promotional communication.

Generally, the FDA takes the position in enforcement and guidance that if a company has authorship or control over a prescription drug message that company is potentially on the hook under the FDCA Act, Davar noted.

The FDA spokeswoman said the agency also has the option, when voluntary compliance is unsuccessful, of working with the Department of Justice to pursue enforcement actions, such as seizures or injunctions.

“I think it’s pretty clear that the FTC is the agency that’s given the most thought and has the broader jurisdiction to go after things like enforcement of testimonials, personal statements from individuals,” and so on, Davar said.

“They (the FTC) are not bound by the same regulatory and statutory definitions that the FDA is about labeling and advertising and intended use. And it’s very clear the two agencies collaborate,” Davar said.

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Still, Davar said it is “vexing” as someone practicing law in this area not to have clearer guidance “from what is in some ways the most important regulator for the pharmaceutical industry in particular (the FDA) and the one that in many cases the industry is most worried about when it comes to reputation, risk, warning letters and that kind of thing.”

Davar said he believes that if the FDA takes more action, it will be based on misleading messages.

Gardner Law’s Downing said it’s less likely the FDA will issue new guidance, “but it doesn’t mean you couldn’t see a new batch of letters.”

Downing also said he can also see the FDA and FTC working more closely on the issue of social media influencers.

He said companies can mitigate risk by taking such steps as improving clarity of disclosures, including possible risks. “Make sure claims they (influencers) make are substantiated,” Downing added.

It’s critical that companies and their regulatory departments and lawyers understand how social media works and who they are working with, Davar said. “In the prescription drug world where I’ve seen issues pop up, it’s largely because people don’t know enough about the personality that they’re working with.”

Some influencers are not used to working with the industry and aren’t good at communicating in literal, straightforward ways. For instance, Davar said an interpretive dancer with 1 million followers might have difficulty communicating technical or scientific information for a depressive disorder drug.

Also, does an influencer have a track record for saying or doing things in a mercurial way or that flies in the face of convention? If that person says things about your company or product that you don’t like, “you don’t want to get into a heated public battle with somebody who has 2 million followers.”

Ultimately, if companies don’t get their social media messaging in line, they also risk the scrutiny of the plaintiff’s bar in court, “outside of the FDA’s jurisdiction, outside of the FTC’s jurisdiction,” Davar said.