Savvy Social Media Causes Problems for the FDA

by | Oct 25, 2023 | FDA, FOIA, Litigation, Pharmaceuticals

In FOIAengine, a Slew of Requests About Ivermectin

Robert Califf headed up the Food and Drug Administration during the last year of the Obama Administration.  By the time Califf spun through the revolving door, returning to his old job early in 2022, he’d picked up some things:  $2.7 million in compensation and as much as $5 million in stock for advising a subsidiary of Google’s parent, Alphabet – and, probably not coincidentally, a keen sense that the FDA was being outhustled in the cyberspace.

Califf set out to do something about that, championing a social-media team at the FDA that uses a mix of savvy and snark to gain impressive traction with audiences on Twitter (now X) and Facebook.  Califf made his intentions clear:  He wanted the FDA to be as innovative with social media as the “snake-oil salesmen” who were “peddling falsehoods” about the risks of covid vaccines and other things.

That strategy worked, perhaps too well.  The FDA’s social-media team, already in place by the time Califf returned, became a lightning rod.

As often happens, early signals of controversy came through requests submitted under the Freedom of Information Act.  FOIA requests to the federal government can be an important early warning of bad publicity or litigation to come – and in this case, the FOIA requests signaled both.

We dug into PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, to better understand how the FDA’s use of viral Twitter posts boomeranged into a federal court challenge that endangers not only the FDA’s ambitious social-media program, but similar endeavors at other federal agencies.  We’ll break it all down below.

The FDA’s most successful tweet ever was one that struck back at covid anti-vaxers and skeptics by mocking those who advocated taking ivermectin, a drug approved for humans, as an off-label treatment for Covid-19.  Since ivermectin also is a veterinary drug used for treating parasites in animals, the riff was easy, if also cheap.

“You are not a horse,” the FDA tweeted in August 2021, along with two photos of medical personnel – including one, with a stethoscope, nuzzling a horse.  “You are not a cow.  Seriously, y’all.  Stop it.”  Those who clicked on the post were taken to a notice on the FDA website:  “Why you should not use ivermectin to treat or prevent Covid-19.”

Overnight, the post went viral, reaching 14.5 million people.  State medical authorities and insurance companies also heard the message and stepped up efforts to prevent ivermectin’s use as a covid treatment.

The FDA post was retweeted 70,000 times and received nearly 110,000 likes.  And it also got 15,500 comments, including many that mocked the FDA and gave credence to the “misinformation” that the FDA intended to quash.

It wasn’t long before a journalist, Linda Bonvie, weighed in with a FOIA request, the first of numerous recent covid-related FOIA requests that she has since made to the FDA.  Bonvie asked for “email and written correspondence both to and from the FDA’s Office of Editorial and Creative Services and the FDA’s web and digital services staff that contain the word “ivermectin.”  There have been at least 85 other FOIA requests for ivermectin-related documents.

Bonvie’s request produced a sheaf of emails that revealed how pleased the FDA was about the traction its ivermectin tweet had received.  Bonvie soon posted some of the emails in a disputatious blog post entitled  “How Four Calls on Animal Ivermectin Launched a False FDA Media Attack on a Life-Saving Human Medicine.”

As Bonvie and her co-author, Mary Beth Pfeiffer, described it, the FDA media team – not the anti-vaxers – were the ones spreading misinformation about ivermectin.  Put simply, they wrote, the drug hadn’t been abused as a quack covid treatment.  Rather, they asserted, the FDA’s media team misinterpreted data and then spun a false narrative about the incidence of ivermectin reactions.

“The story behind the tweet that went ‘round the world,” the two journalists wrote, “shows how a myth was born about a safe, if now controversial, human drug that was FDA-approved for parasitic disease in 1996 and bestowed the Nobel Prize in Medicine in 2015.  It is a story in which the barest grain of truth morphed into an anything-goes media firestorm.”

Still, FDA officials had been elated with the uptake.  Erica Jefferson, an associate commissioner, emailed her boss, Janet Woodcock:  “The numbers are racking up and I laughed out loud.”

Two years later, it’s not such a laughing matter.  The results of the FDA’s campaign are unfolding in what, for the agency, is an unwelcome venue – the federal courts – and with unintended results that could hamstring not just the FDA but other regulators employing similar tactics.

That is because three doctors who’d been prescribing ivermectin for their covid patients – a lawful, if unorthodox, practice – filed suit against the FDA after encountering problems as the agency’s ivermectin warnings took hold.  An Arizona doctor, Robert Apter, faced medical-board disciplinary charges.  A Texas doctor, Mary Talley Bowden, was forced to resign her privileges at Houston Methodist Hospital.  Paul Merick, once a highly regarded scholar at Eastern Virginia Medical School, lost his professorship there.

The three doctors turned to Boyden Gray, a cause-oriented boutique law firm in Washington that specializes in “the most difficult issues across law, public policy, and politics.”  The doctors filed suit in federal court in Galveston, seeking an injunction to prevent the FDA from regulating the practice of medicine.

In essence, the doctors are asking the court to require the FDA to stay in its drug-approval lane, and to stop giving medical advice.  The FDA, in court filings, denied that its tweets and warnings constituted advice.  The agency also claimed sovereign immunity.

Last month, a federal appeals court ruled that the doctors’ case against the FDA can move ahead.  “Tweet-sized doses of personalized medical advice are beyond” the FDA’s statutory authority, the Fifth Circuit ruled.  If other jurisdictional hurdles are cleared, the FDA may stand trial on whether it overstepped its authority with that social-media post and its other warnings about ivermectin.

Now the case is headed back to federal district court.  An adverse decision could clip the wings of agencies that, like the FDA, have turned to social-media outreach as a means of influencing consumer behavior. “The FDA does not comment on possible, pending, or ongoing litigation,” a spokesperson for the agency said.

At least one other federal agency, the Securities and Exchange Commission, has sought to harness the viral power of social media.

FOIA requests about the cost and efficacy of the SEC’s efforts started coming in after the agency began posting clever “Office Hours” videos on You Tube.  In the videos, SEC Chairman Gary Gensler uses a mix of humor and plain talk to explain what the agency does.

A recent “Office Hours” video opened with Gensler, pointing to a mocked-up image of a dog inside a fish, asking:  “What do the securities laws have to do with goldfish?”  Click here for the answer.

To learn more about the requests mentioned in this article, log in or sign up to become a FOIAengine beta user.

Next:  Pfizer and Moderna, weight-loss drugs, and marijuana.

John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere.  He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis.  His most recent book is The Partisan: The Life of William Rehnquist.  Jenkins founded Law Street Media in 2013.  Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly.  FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller.  Learn more about FOIAengine here.  To review FOIA requests mentioned in this article, subscribe to FOIAengine. 

Write to John A. Jenkins at [email protected].

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