What can FDA really do about DTC pharma advertising?
Two weeks ago, the US FDA announced a crackdown on direct-to-consumer advertising, causing significant consternation for the pharma industry, not to mention the sizeable sub-industry that is pharma marketing.
And while the announcement has been followed up by a slew of warning letters and an editorial from Commissioner Dr Martin Makary, the details of what exactly FDA plans to do and how it plans to do it remain a bit fuzzy.
A two-pronged crackdown
It’s a matter of public record that if HHS Secretary Robert F. Kennedy Jr had his way, he’d ban direct-to-consumer pharma advertising all together. Although this has been done in most other countries, in the United States courts have been clear that commercial speech is protected by the First Amendment.
So, the FDA has advanced a two-pronged approach: In the short term, the agency is using its existing enforcement authority over pharma advertising, but using it more zealously than it has in many years. In the longer term, it’s engaging in rulemaking to rescind a 1997 guidance that has allowed companies to abbreviate safety disclosures in advertisements if the full information is available elsewhere.
This short-term enforcement tactic is what the warning letters that went out last week represent, and it’s only an effective tactic where FDA can make a real case that ads are deceptive and misleading according to current guidance.
And there’s a subtle difference between how the FDA is talking about those letters and the nature of the letters themselves, according to Seth Mailhot, a Partner at Barnes & Thornburg who specialises in FDA regulatory and enforcement matters and a former compliance officer at the agency,
“When they use the term ‘cease and desist letter', which appeared in their press release, appeared in Makary's op-ed that appeared in the New York Times, that's not a letter that we, as FDA practitioners, are familiar with,” he told pharmaphorum. “What we've seen is it's not cease and desist letters. It's not some new type of letter. It's the standard warning letters and untitled letters that we're more used to seeing.”
About that loophole…
It’s not the enforcement of existing rules that has pharma worried. It’s the prospect of that rule change that could force companies to list extensive safety information, an onerous requirement that could lead some companies to abandon broadcast advertising altogether.
But Mailhot says it’s not at all clear what FDA means by “rulemaking” or how they could accomplish that change before the current administration ends.
The 1997 rule change FDA has referred to is actually a regulatory guidance that was issued as a draft in 1997 and finalised in 1999. It doesn’t have the force of law. Changing the regulation itself requires, by statute, an extensive notice and comment period. Mailhot estimates it would be a 10-year process.
Issuing a new guidance, the agency’s avenue for amending the language in the 1999 guidance, also requires a long process — but a two- to three-year process, rather than a decade-long one.
“The problem is that, when they get into the rulemaking process, in particular, they are going to run into issues related to comments that come back from industry and from others that push back on their position,” Mailhot said. “Commercial speech, in particular, is a long-standing topic of interest on both sides of the aisle. But in particular, the Republicans are very strong advocates of protections of commercial speech. So, I think FDA is going to have a more difficult time trying to thread the needle on that.”
FDA has talked about rescinding the guidance. That’s something they could do unilaterally – but it might not work out as well for them as they expect.
“They can take away the guidance document, but the guidance document really only says, what does FDA mean when it said, ‘adequate provision’ in the regulation?” Mailhot said.
Rescinding the guidance without replacing it just leaves the definition of ‘adequate provision’ up to interpretation, allowing companies to interpret it as strictly or freely as they want. They could plausibly use the change in the technological landscape since 1999 to argue that a website or QR code should be accepted as an adequate provision now, Mailhot said.
“In fact, if the goal is […] to stop broadcast advertising altogether, well, that requires a whole lot more than just rescinding the 1997 guidance,” Mailhot said.
How should companies be responding?
The FDA may well have more difficulty implementing its plan than its rhetoric suggests. But that doesn’t mean pharma companies shouldn’t prepare for the worst.
Angela Tenuta, global group president of agency solutions for pharma commercialisation company EVERSANA, says pharma should be proactive in preparing for whatever FDA has planned.
This means auditing existing ad spots and creating pivot plans that include longer ads or shifts to other platforms.
“This is not the end of pharma marketing, but it does signal a shift: every piece of creative will live under closer scrutiny,” she said. “Campaigns that are both compelling and compliant should endure.”
Tenuta also advises responding “quickly and strategically” to any letters from the FDA.
“Prepare a detailed, strategic response addressing each FDA concern, defending your interpretation of regulations, and providing supporting documentation,” she said. “Take corrective action where appropriate, ceasing distribution of flagged materials and documenting changes.”
Mailhot agrees that pharma companies should be putting their messaging through more rigorous review, and perhaps preparing contingency plans like using broadcast channels for awareness campaigns, rather than direct product marketing.
“But I don't think that this avenue is necessarily closed at this point,” he said. “I think we're just in a phase where companies need to be more careful about the presentation of risks and see how this plays out.”
