Let me take you behind the scenes of a Jazz Pharmaceuticals case that could have happened to any of us. In my early years as a final signatory I found myself agonising over whether mentioning a drug's brand name too many times in a Press Release could result in a code breach. Turns out, i wasn't alone!
What happened – Dissecting the Jazz Pharmaceuticals Press Release
Let’s break down the real story behind the Jazz Pharmaceuticals press release and the subsequent PMCPA Code ruling—a case that’s become a great example for press release compliance in pharma.
On 10 August 2021, Jazz Pharmaceuticals issued a press release announcing MHRA approval for Epidyolex (cannabidiol) as a treatment for seizures associated with tuberous sclerosis complex (TSC) in patients aged two years and older. This was a significant regulatory milestone for cannabidiol seizure treatment and a standard moment for industry communication. Fast forward to 13 June 2024, when an anonymous health professional submitted a health professional complaint to the PMCPA, alleging two main breaches:
The press release was “promotional” due to the “overuse” of the Epidyolex/Epidiolex brand name (seven mentions).
The release was “not fair and balanced” because it omitted specific serious side effects (hepatocellular injury, seizures, pneumonia) observed in the referenced Phase 3 trial.
The complaint triggered a review of several clauses in the 2021 ABPI Code: Clause 6.1 (fair and balanced information), Clauses 12.1, 12.6, 12.9 (prescribing and adverse event reporting), Clause 5.1 (high standards), and Clause 2 (industry confidence).
Jazz Pharmaceuticals’ response: Context is everything
Jazz Pharmaceuticals responded by emphasising that the press release was not promotional but rather a factual, regulatory announcement. They highlighted that:
The brand name Epidyolex was used only once in the main body (the headline), with the remaining six mentions appearing in the “Additional information” section, which provided background for journalists.
This structure is industry standard and aligns with Clause 26.2 of the Code, aiming for clarity, especially since Epidiolex and Epidyolex are marketed under different names in various regions.
The press release was distributed solely to UK healthcare and trade media, not the general public, and was later archived deep in their website.
Including prescribing information or adverse event reporting would be inappropriate for a non-promotional regulatory announcement.
PMCPA Panel’s ruling: Nuance matters in Press Release compliance
The PMCPA Panel’s review focused on two key questions:
Did the frequency and placement of the brand name make the release promotional?
Was the safety information sufficiently fair and balanced?
After dissecting the structure, the Panel found that the brand name was not overused in a promotional context. The mentions in the supplementary section were deemed appropriate for clarity, not marketing. Thus, no breach was found regarding promotional content or the need for prescribing/adverse event information.
However, the Panel did find a breach of Clause 6.1. While the press release cited a 49% seizure reduction (versus 27% for placebo) from the Phase 3 trial, it failed to mention key serious side effects or direct readers to the summary of product characteristics - I would stress:
"Providing sufficient, balanced safety information in every external communication—regardless of purpose—should be a golden rule for any medical affairs or compliance team."
This case reminds us: context matters, but so does balanced safety detail—even in non-promotional communications about Epidyolex for TSC and other therapies.
The real insight – More than just counting Brand mentions
When I first read the complaint about Jazz Pharmaceuticals’ Epidyolex press release, it was tempting to focus on the numbers: seven mentions of the brand name. But the real lesson from this PMCPA case is that compliance isn’t a numbers game—it’s about context, tone, and, above all, content. The Panel’s deep dive into the Epidyolex safety profile and the adequacy of safety information shows that even a routine regulatory milestone announcement can cross the line if it leaves readers underinformed about risk.
Context and Content Trump Counting
Jazz’s defense rested on the idea that mentioning Epidyolex seven times—mostly in the “Additional information” section—was standard practice, not promotion. The Panel agreed, noting that the brand name appeared only once in the main body and the rest were in a context meant for clarity, not marketing. This is a crucial point for pharma teams: it’s not just how many times you mention a drug, but where and why. The PMCPA Code (especially Clause 6.1) requires that recipients have enough information to form their own opinion of a medicine’s value. That means every press release, even about a regulatory milestone, must be scrutinised for balance and completeness—not just for brand frequency.
Safety information: Never an afterthought
Despite the non-promotional intent, the Panel found Jazz’s press release lacking in one critical area: safety information. The omission of specific adverse events—hepatocellular injury, seizures, pneumonia—from the clinical trial updates was not just a technicality. These details, while not new, were significant enough that their absence tipped the release into non-compliance. As i would put it:
“Press releases should never leave the reader guessing about safety, even in the excitement of a regulatory win.”
Clause 6.1 was breached because the press release didn’t provide a fair and balanced picture of the Epidyolex safety profile. The Panel emphasised that, regardless of intent, full transparency is required in external communications. It’s not enough to say “no new safety risks identified” if known risks are omitted. Being thorough with safety updates is a basic expectation, not an ‘extra’.
Industry standards sren’t infallible
Jazz followed what they believed to be industry-standard practice, but this case proves that “standard” doesn’t always mean “sufficient.” Every communication—routine or not—needs the same scrutiny as overtly promotional material. The Panel’s main concern wasn’t the number of brand mentions, but the risk that the audience (including healthcare professionals and possibly the public) could be misled or underinformed about adverse events. This is a reminder to all pharma teams: always double check for fair balance, especially around adverse event reporting and drug safety.
Context, not just frequency, determines if a release is promotional.
Minimal safety data can trigger non-compliance—even for regulatory news.
Omitting known adverse events undermines fair balance and breaches the PMCPA Code.
So What? How to future-proof your pharma communications
After dissecting the Epidyolex press release ruling, one thing is clear: regulatory compliance isn’t just about ticking boxes—it’s about building trust and protecting your reputation for the long haul. The PMCPA’s review of a years-old, archived press release is a wake-up call for every pharma team. Even routine communications, like a press release announcing a new indication, can become a compliance flashpoint if not handled with care. From my own experience:
"The best compliance advice I ever got? Yes, even routine news can get you audited. Treat every line as if you’ll have to defend it in a PMCPA case."
So, what does this mean for future-proofing your press releases and other healthcare media outputs? First, never take shortcuts with safety information. Even if your communication is for a non-promotional purpose—like sharing regulatory milestones—always include a fair, clear summary of the most important safety data. The Epidyolex case shows that omitting key safety details, even in a press release, can lead to a breach of the ABPI Code (Clause 6.1). It’s not enough to say “no new safety risks identified” if the audience could include non-specialists or the general public. Transparency and clarity must be your default, not an afterthought.
Second, consider your audience carefully. If your press release could be picked up by non-specialist media or accessed by the public—even years later from your press release archive—aim for language and content that is accessible and balanced. The Panel’s concern in this case wasn’t about how many times the brand name appeared, but whether the information was fair and balanced for all potential readers. Regulatory compliance means thinking beyond the immediate recipients and anticipating how your message might be interpreted in the future.
Third, never underestimate the value of mentorship and independent review. I’ve personally seen last-minute advice from a code mentor sway high-stakes sign-offs and prevent costly mistakes. Having a compliance expert or ABPI signatory as your safety net can catch blind spots that internal teams might miss—especially when it comes to routine communications that don’t always get the same scrutiny as core marketing materials. Mentorship and external advice aren’t just nice-to-haves; they’re essential for robust complaint response and long-term compliance.
Finally, maintain a well-organised, easily accessible press release archive with robust compliance checks. What you publish and archive today could be reviewed under current compliance guidelines years from now. Long-term compliance is not just about what’s in the headlines today, but about ensuring your entire archive stands up to future scrutiny. Treat every press release—no matter how routine—as if it could become the subject of a PMCPA case tomorrow.
In summary, future-proofing your pharma communications means embedding regulatory compliance, transparency, and expert review into every step of your process. The Epidyolex ruling is a timely reminder: routine news can become a regulatory headache if you’re not vigilant. Treat every communication as a potential compliance case, and you’ll be ready for whatever scrutiny comes your way.