There’s a yawning chasm in the Food and Drug Administration’s oversight of advertising and telehealth companies have found ever-more daring ways of exploiting it.
One of the latest examples involves Sparks, the compounded, under-the-tongue drug combining the active ingredients in older erectile dysfunction (ED) drugs Viagra (sildenafil) and Cialis (tadalafil).
Telehealth company Ro has been advertising Sparks through multiple consumer media channels for months.
Telehealth providers are reportedly not covered by FDA’s general oversight of the prescription drug promotions of drug manufacturers, packers or distributors. That gap means these firms have nearly free reign to advertise Rx drugs basically anywhere they wish.
In Sparks’ case, that includes out-of-home (OOH) ads, as well as spots on television and the use of TikTok influencers to proclaim that the drug “works faster than Viagra” and lasts 36 hours.
Importantly, these ads do not adhere to traditional FDA requirements on accuracy, side effect disclosures or fair balance of risk information.
A two-decade old SCOTUS case
Sparks takes advantage of another legal gray area, too.
In 2002, the Supreme Court ruled in Thompson v. Western States Medical Center that Congress’s ban on the advertising of compounded drugs was unconstitutional.
While that decision essentially lifted the prohibition on marketing compounded therapies, it pertained to traditional compounding, where drugs are made for individual patients or in small batches for those with specialized medical needs.
This would apply to a patient who has allergies and needs a medication to be made without a certain dye.
“Western States was not about the type of compounding that Ro is doing,” observed Dale Cooke, a pharma industry attorney specializing in communication issues.
In Western States, the government had sought to defend the FDA’s restriction on advertising compounded drugs, arguing that mass marketing was a good demarcation between small-scale compounding and large-scale manufacturing and distribution of the type FDA would deem a “new drug” requiring approval.
However, the Supreme Court disagreed, ruling that the government had other ways to curb compounding other than an ad ban, such as limiting the amount of compounded drugs a company could make.
Finding a loophole
Sparks exploits that lack of DTC restrictions in a unique way. It’s a fixed-dose combination (FDC) product, a single product with two active ingredients that have previously been approved individually but not in combination.
Although there are other FDCs where none of the active ingredients were previously approved, generally speaking, FDCs that haven’t passed FDA muster in combination require a whole new approval.
Compounded drugs, though, are an exception.
So, regardless of whether the agency has approved any combination of ED treatments – a spokesperson for the agency told MM+M it has not – the question is moot from the perspective of advertising a compounded therapy.
By leveraging the loophole in Western States, Ro has “essentially found a way to introduce a new drug into the mass market without getting FDA approval,” explained Cooke, president of PhillyCooke consulting.
The FDA declined to discuss the details of Sparks with MM+M.
That said, in response to Ro’s recent LinkedIn post showing ads for Sparks in New York’s Pennsylvania Station, an FDA official’s comment under the post reads – with a hint of sarcasm – “I liked the disclaimer about compounded drugs,” along with the thinking emoji.
The official’s LinkedIn profile indicates he is an FDA branch chief in the office of compounding quality and compliance.
Compounding pharmacy exec weighs in
Ro includes the following statement on its website and in ads for the drug: “Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review.”
That disclaimer is required any time a compounded drug is marketed, pointed out Shawn Hodges, CEO of Revelation Pharma, which operates a network of compounding pharmacies.
Likewise, any telemedicine company needs to go out of its way to advise patients that these are compounded therapies that have not been approved by the FDA, explained Hodges, who previously served in leadership roles for the industry’s trade group – the Alliance for Pharmacy Compounding.
Sparks’ ads tout the drug as “fast-acting,” due to its sublingual formulation.
Ro notes that Sparks “is absorbed directly into the bloodstream via the blood vessels under the tongue, rather than getting absorbed in the stomach.”
Elsewhere, the company says that mixing different ED ingredients and putting them in a sublingual formulation is a “unique way to experience benefits like longer-lasting effects and quicker onset of medications.”
Ro also points to a study showing that such formulations may work faster than traditional ED pills.
An additional claim that the drug “lasts 36 hours” is a nod to its Cialis component.
Indeed, according to information on various drug sites, tadalafil can remain effective for up to 36 hours, although peak concentration in the bloodstream usually occurs between 30 minutes and 6 hours.
Nevertheless, telehealth providers need to be careful when making such claims, because it’s not their compounded therapies that were involved in the reference studies, cautioned Hodges.
“Some companies will say, ‘This compound works for X number of hours.’ That actually may be true because they’re referencing studies, but those compounded therapies were not part of the study,” he said. “You have to draw a line of distinction at some point to make sure that, ‘OK, if you’re changing a dosage form, if you’re changing the strength, that that compounded therapy may not apply to the study that you’re referencing to make that claim of efficacy.’
Hodges said we should collectively exercise some caution about that – before adding that his views are his own and do not reflect official policy.
Potential congressional intervention
Ro is taking advantage of the loophole the Supreme Court created to advertise a compounded drug that appears to otherwise require FDA approval.
Since the Western States case, there have been no attempts by Congress to revise the rules for compounded drug marketing, Cooke said.
In the meantime, the attorney observed, telehealth firms are completely undermining the drug-approval process.
However, there seems to be renewed pressure for tougher regulation of these companies.
In February, Sens. Mike Braun, (R-IN), and Dick Durbin, (D-IL), called on the FDA to take “swift action” to update its enforcement tools to reflect the current platforms and methods used to promote prescription drugs and biologics.
That included asking FDA Commissioner Dr. Robert Califf whether the agency’s ad regulations apply to telehealth companies. The commissioner’s responses were due in April.
When asked to explain how the FDA responded to this question, the agency’s spokesperson told MM+M, that any “agency engagement would be with Congress directly and would involve responding directly to the senators.”
