CASE/0724/09/25
COMPLAINANT v ELI LILLY
Alleged promotion of orforglipron in a newspaper article
CASE SUMMARY
This case was in relation to an article that appeared on the website of a UK national news publication. The article featured an interview with a global senior leader from Eli Lilly. The complainant alleged that the article promoted Lilly’s investigational weight loss pill, orforglipron.
The outcome under the 2024 Code was:
| Promoting a medicine prior to the grant of its marketing authorisation |
| |
This summary is not intended to be read in isolation.
For full details, please see the full case report below.
FULL CASE REPORT
A complaint was received about Lilly from an anonymous, non-contactable complainant, who stated they worked in the pharmaceutical industry but were submitting a complaint in a personal capacity.
COMPLAINT
The complaint wording is reproduced below:
“Complaint Regarding Breach of ABPI Code by Lilly – Promotion of Orforglipron. I am submitting this complaint regarding Eli Lilly’s recent public promotion of its investigational weight-loss pill, Orforglipron, as reported in [national news publication] on 7 September 2025 ([Article title] by [named journalist]). I believe this constitutes a breach of the ABPI Code of Practice 2024, specifically: Clause 2 – Bringing discredit upon and reducing confidence in the pharmaceutical industry. Clause 3.1 – Promotion of a medicine prior to the grant of a marketing authorisation. Clause 9.1 – Failing to maintain high standards. Clause 26.1 – Advertising prescription-only medicines to the public.”
When writing to Eli Lilly, the PMCPA asked it to consider the requirements of Clauses 3.1, 5.1, 26.1 and 2 of the 2024 Code.
ELI LILLY’S RESPONSE
The response from Lilly is reproduced below:
“We acknowledge your letter dated 10th September 2025, detailing a complaint regarding alleged promotion of orforglipron in a newspaper article.
Lilly takes compliance very seriously and understands and fully respects the ABPI Code of Practice.
Orforglipron is a medicinal product under investigation by Lilly for both type 2 diabetes and weight management. At this time no regulatory submission to the MHRA has been made, and the product is not yet licensed and does not hold a marketing authorisation in the UK or in any other country around the world. Therefore, we are unable to provide a Summary of Product Characteristics for this product.
The article in question followed an interview between [named global senior leader], and [named journalist] at the [named national news publication], which was held in Kinsale, Ireland on Wednesday 3rd September.
The interview was the result of an initial call to gauge interest followed by an email invitation sent to [named journalist] on 26th August by [named communications agency], a third party communications agency employed by Lilly UK, inviting [them] to a site tour at Lilly’s manufacturing site in Kinsale, Ireland on 3rd September with an opportunity to interview [named global senior leader] and [another named senior leader]. [Named journalist] accepted the invitation to join the site tour and to interview [named senior global leader].
A full written and verbal briefing was given to [named senior global leader] ahead of this interview. The intended topics of the interview, as proposed to [named journalist] verbally by [named communications agency] in advance, were:
- Lilly’s commitment to Europe and manufacturing investments
- Lilly’s view of what European Governments need to do to ensure competitive life sciences environments in their countries.
- Lilly’s view of obesity as a disease and the potential to tackle the economic and societal impact of obesity in European countries.
The briefing document was focused on these three areas and no instruction to raise orforglipron proactively was given in the briefing document. The briefing document was examined by email, in line with Lilly’s Conducting Public Relations Activities procedure, by [named senior medical employee]. [Named senior medical employee] is a registered health professional and ABPI final signatory.
A representative of the UK Communications team attended the interview to ensure compliance. The interview lasted 33 minutes with 29 minutes focused on manufacturing, the life sciences environment and obesity as a disease state. During the interview, the journalist asked three unsolicited questions about orforglipron which were answered in a way that was factual and balanced, did not encourage members of the public to ask their doctors or other prescribers to prescribe orforglipron, and was in line with the principle of the Code that information on medicines provided in response to a direct request must be limited to that information necessary to respond to the request. These three questions took up 4 minutes of the 33-minute interview. [Named senior global leader] did not proactively raise the topic of orforglipron.
The journalist asked if and when Lilly would submit orforglipron for regulatory approval in the UK, whether Lilly considers orforglipron as a ‘game changer’ due to the ease of manufacturing and distribution, and if orforglipron would be made in Kinsale. [Named senior global leader] answered factually. The journalist used the phrase ‘game changer’ in [their] question to [named senior global leader] related to manufacturing and distribution and [named senior global leader] discussed this in the sense that manufacturing and distribution of oral treatments is a step change from the current situation with injectable medicines. [They] did not make any claims related to the efficacy of orforglipron and clarified to the journalist that the phase 3 data for orforglipron shows lower weight loss than with currently marketed injectable weight management medicines.
The licensing status of orforglipron was made clear by [named senior global leader] in [their] answers. [They] clearly stated that orforglipron had not yet been submitted for regulatory approval and stated that [their] comments about scaling manufacturing were subject to regulatory approval.
The article in question was written independently by [named journalist] and published on 7th September. Lilly had no opportunity to review the content prior to its publication by [named national news publication]. We note the following cases, which make clear that, in the event of a complaint about material published independently by a journalist, the PMCPA is required to rule on the basis of the original material provided by the company, and not the final version edited by a journalist:
· Case AUTH/3591/12/21: ‘complaints to the PMCPA about third party media articles are judged on the acceptability of the information provided to that third party by the pharmaceutical company, rather than the final published article'; ‘The Appeal Board agreed with the Panel that it was obliged to make its rulings based on what [the company’s] CEO had actually stated rather than the edited published article and video’.
· Case AUTH3691/9/22: ‘The Panel noted that when complaints were received about information that an independent journalist had published in the press, its rulings were made upon the material released by the company that might have prompted the article, and not the article itself’.
In response to the request to consider the clauses below, Lilly believes all requirements of these clauses were met during this activity:
Clause 3.1 A medicine must not be promoted prior to the grant of the marketing authorisation which permits its sale or supply.
Promotion within the code definition means ‘any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply, or use of its medicines’. As explained above, nothing in [named senior global leader’s] interview responses encouraged the use of orforglipron for weight loss, or any other purpose. [They were] clear that product was not authorised and could not be offered to patients prior to authorisation.
For completeness, we add that product information was only given reactively in response to specific questions from a journalist and was limited to the information necessary to respond to the request. We do not believe that these questions were in any way solicited: the invitation to the journalist for the site visit and interview did not include orforglipron and [named senior global leader] was not briefed to proactively talk about orforglipron.
Clause 26.1 Prescription only medicines must not be advertised to the public.
Whilst the code does not define ‘prescription only medicine’, the Human Medicines Regulations 2012 definition is “a medicinal product that is covered by an authorisation of which it is a term that the product is to be available only on prescription”. As explained above, orforglipron is an investigational medicinal product and therefore does not currently have a marketing authorisation and is not currently a prescription only medicine. On that basis, Clause 26.1 does not apply.
Clause 5.1 Companies must maintain high standards at all times.
In line with the code requirement for companies to have policies to clearly communicate corporate standards, expectations and behaviour, Lilly has implemented a Conducting Public Relations Activities procedure. Both Lilly and [named senior global leader] followed this procedure at all times in relation to the media interview. [Named senior global leader] received a clear written briefing, which had been examined by a Medical signatory, and a verbal briefing to reinforce the information that was in the written briefing. In accordance with this briefing, [they] gave no information about orforglipron to the journalist proactively. As to the information that was provided reactively, please see our comments above.
Clause 2 Upholding Confidence in the Industry
We note that a ruling of breach of Clause 2 is a sign of particular censure, reserved for such circumstances. We do not consider that a media interview which followed all Lilly’s procedures, where no information was proactively shared about orforglipron, and where such information as was shared reactively was entirely factual, balanced and non-promotional, would bring discredit upon, or reduce confidence in, the pharmaceutical industry. As such, we do not feel that it amounts to a breach of Clause 2.
In summary, we believe that the media interview in question met the requirements of the Code and of Lilly’s relevant procedures, and therefore we refute the allegations of breaches of Clauses 3.1, 26.1, 5.1 and 2.
We trust that this resolves the matter to your satisfaction and remain available to answer any questions you may have.”
Further response from Eli Lilly
Further information was provided by Eli Lilly in response to a request for additional information by the Panel. The response from Eli Lilly is reproduced below:
“I’m responding to your questions below, as requested.
1. Given Eli Lilly's knowledge of the questions asked by the journalist regarding orforglipron, can you confirm if a transcript or any other notes or recording regarding the interview are available and if so, please can you provide a copy?
Please find attached a transcript of the section of interview related to orforglipron. These questions were initiated by the journalist. The questions were unsolicited, were answered factually and the information given was limited to the information necessary to respond to the request.
2. Appendix 1 provided by Eli Lilly (email invitation to the journalist) appears to not be the initial communication regarding the interview. Are you able to provide a copy of the initial communication and any information or material provided to the journalist in advance of the interview?
As outlined in our original response letter, the interview was the result of an initial telephone call to the journalist to check their interest in visiting a Lilly manufacturing site, followed by the email invitation which was attached as appendix 1 to our response. We don’t have any other written communication about this event prior to the email sent on 26th August.”
PANEL RULING
This case was in relation to an article that appeared on the website of a UK national news publication. The article featured an interview with a global senior leader from Eli Lilly (Lilly). The complainant alleged that the article promoted Lilly’s investigational weight loss pill, orforglipron.
Lilly submitted that the interview was a result of the health journalist from the publication being invited on a site tour of Lilly’s manufacturing site in Kinsale, Ireland with an opportunity to interview two senior leaders from Lilly. The journalist accepted the invitation and interviewed the global senior leader. A member of Lilly’s UK communications team also attended the interview to ensure compliance.
Lilly provided a copy of the article downloaded from the publication’s website. The Panel noted that when complaints were received about information that an independent journalist had published in the press, its rulings were made upon the material released by the company that might have prompted the article, and not the article itself. The tone, language and content of any interactions the company had with the journalist, would be important considerations in this regard.
Lilly submitted that during the interview, which lasted 33 minutes in total, the journalist asked three unsolicited questions regarding orforglipron which took up 4 minutes of the interview. Lilly had provided a transcript for these specific sections of the interview. The Panel, therefore, made its rulings based on this original transcript.
Pre-Licence promotion (Clause 3.1)
The complainant alleged that the article promoted Lilly’s investigational product orforglipron.
Lilly confirmed that at the time of complaint, orforglipron was a medicinal product under investigation by Lilly for type 2 diabetes and weight management. The product was not yet licensed and did not hold a marketing authorisation in any country in the world.
Lilly submitted that the intended topics of the interview, as proposed by the journalist, were Lilly’s commitment to Europe and manufacturing investments; Lilly’s view of what European Governments need to do to ensure competitive life sciences environments in their countries; and Lilly’s view of obesity as a disease and the potential to tackle the economic and societal impact of obesity in European countries. Lilly submitted that during the interview, the journalist asked three unsolicited questions about orforglipron which were answered by the global senior leader in a factual and balanced way. The answers provided were in line with the principle of the Code that information on medicines provided in response to a direct question must be limited to that information necessary to respond to the request.
Lilly further submitted that the global senior leader did not make any claims related to the efficacy of orforglipron and in fact clarified to the journalist that phase 3 data for orforglipron showed lower weight loss than with currently marketed injectable weight management medicines. The senior leader also made clear the licensing status of orforglipron in their answers.
Clause 3.1 of the Code stated that a medicine must not be promoted prior to the grant of a marketing authorisation which permits its sale or supply.
The Panel accepted that it was permissible for pharmaceutical companies to answer unsolicited questions from journalists about medicines provided that answers were not promotional and were factual and balanced.
The Panel considered the three questions posed by the journalist regarding orforglipron and the answers provided by the global senior leader from Lilly, as detailed in the transcript excerpt provided. Whilst the Panel considered the answers provided by the global senior leader to two of the journalist’s questions were factual and limited to the information necessary to answer the question, the Panel were concerned with the answer provided to the third question:
“Journalist: Just so I get it right, in your words, orforglipron is that a game changer because of how easy it is to manufacture, distribute it and take as a patient? I mean it’s kind of the weight loss isn’t as much perhaps but it’s so much more convenient, cheaper. I assume it’s cheaper to make and cheaper to [sic] it will be cheaper to buy as well.
Senior Leader: You know, I think it depends on how you define a game changer, but if I use your word yes, through that lens, it is a game changer because I think at the end of the day yes the weight loss is not at the degree of what you get with tirzepatide for example, but the huge majority of patients with obesity today have a BMI below 35. And not everyone is out after the maximum weight loss. They have a target in their mind and I think for those patients with a BMI in between 27 and 32 35 [sic] orforglipron can probably meet their needs well.
Second Lilly employee: If approved
Senior Leader: Yes, yes if approved. And you know. Quite a few patients have a preference for an oral treatment over an injectable as well. Despite all the utilisation of injectables today many patients wouldn’t take it because there is a needle fear. And thirdly, I think our ability to scale here, even if we have been investing billions of dollars in new manufacturing sites and even if I take the combined capacity of us and the competition, we cannot meet the global needs with injectables. So I think here we have an opportunity as well to reach patients in parts of the world where we don’t rely on the cold chain. So I think it is an opportunity to really scale and provide treatment for patients that otherwise wouldn’t access or wouldn’t consider an injection.”
The Panel considered that the global senior leader had gone beyond providing limited information necessary to answer the question. The global senior leader had referred to the potential efficacy of orforglipron in a certain subgroup of patients, those with a BMI between 27 and 35. Although the journalist had referred to the amount of weight loss achieved with the oral formulation as being less than those of injectables, as confirmed by the global senior Lilly leader, their question had focused on whether orforglipron could be considered a “game changer” due to “how easy it is to manufacture, distribute it and take as a patient?”. The journalist had not directly asked a question about the efficacy of orforglipron.
The Panel noted that the global senior leader’s response closely matched wording that appeared in the article as follows:
"He said the pill would also be attractive to patients who had a body mass index of between 27 and 35 — overweight to mildly obese — who are not chasing the maximum weight loss offered by Mounjaro. “They have a target in mind. For those patients, Orforglipron can probably meet their needs extremely well, if approved.””
In providing efficacy information about an unlicensed medicine beyond what was necessary to answer the question, the Panel concluded that the statement from the global senior leader at Lilly promoted orforglipron prior to the grant of the marketing authorisation. The Panel ruled a breach of Clause 3.1.
Advertising prescription-only medicines to the public (Clause 26.1)
The complainant alleged that the article advertised a prescription-only medicine to the public.
Clause 26.1 of the Code stated that prescription-only medicines must not be advertised to the public.
Whilst the Panel noted that the global senior leader from Lilly had referred to tirzepatide (Mounjaro) in their response to one of the questions on orforglipron, the complainant had only made reference to orforglipron in their complaint. It was not the responsibility of the Panel to make out allegations on behalf of the complainant.
The Panel noted Lilly’ submission that at the time of the complaint, orforglipron was an investigational product which did not have marketing authorisation in any country. The Panel concluded that orforglipron could not therefore be considered a prescription-only medicine at the time of the complaint and ruled no breach of Clause 26.1.
High standards (Clause 5.1)
The complainant alleged that Lilly had failed to maintain high standards.
The Panel considered the context in which the interview had been given:
· Lilly had proactively initiated the interview, inviting the journalist to a site tour of the manufacturing facility and providing them with the opportunity to interview two senior leaders at Lilly.
· The interview was conducted with the health journalist of a mainstream UK news publication and was therefore likely to reach a wide audience of the general public, especially given the public interest in this therapeutic area.
· The interview took place shortly after (within a month according to the published article) the publication of the latest clinical trial results for orforglipron.
The Panel concluded that it was foreseeable that an interview conducted with this specific journalist at this time would likely include questions on orforglipron.
Lilly provided the briefing material it had used to prepare the global senior leader for this interview. The Panel noted a boxed section at the start of the written briefing stated:
“The main compliance risk area for UK, Ireland, Denmark and Sweden media interviews is the risk of promotion of medicines to the public, which is illegal in all four countries.
Discussions regarding disease state (e.g. obesity), without any reference to specific medicines/classes of medicines (e.g. GLP-1s) can be conducted proactively. Your responses must be strictly non-promotional and must not proactively refer to any medicines or class of medicines that are available or may be available in the future.
If asked specific medicines: Discussions about Lilly medicines can only be conducted reactively. Questions from the journalist must be unsolicited (not prompted by Lilly) and specific. The response must be factual, balanced, non-promotional and limited to the information necessary to address the question.”
The briefing material included a number of key messages in relation to government action, Lilly’s investments and obesity as a health condition. The Panel noted that the only reference to orforglipron in the briefing was in a section titled ‘Hot topics and watchouts’:
“[Ireland] Will Kinsale/Limerick be involved in the manufacturing of Orforglipron?
· Lilly’s multi-billion-dollar investments in Ireland (Kinsale and Limerick 2024) continue to play a key role in Lilly’s ability to meet demand for our medicines of today and in the future.”
This section also included the following guidance:
“If asked any questions about any other individual medicines (licensed or in development) or Lilly clinical trials
I’m not able to discuss specific information about our medicines/clinical trials. What’s important…[bridge to talking points above as relevant].”
Whilst the Panel acknowledged that the briefing included upfront guidance if asked about specific medicines, the Panel were concerned that no specific guidance was given on answering questions about orforglipron, apart from manufacturing location, given the likelihood of the global senior leader receiving questions on the medicine. It was also not clear to the Panel whether the last section, as referred to above, was intended to cover questions of orforglipron given the reference to “other individual medicines” (emphasis added by Panel).
The Panel noted the interview was with a health journalist from a national news publication and would likely reach a wide audience of the general public and that the medicine was in a therapeutic area of great current public interest and scrutiny. In the Panel’s view it was entirely foreseeable that the global senior leader would be asked about orforglipron and therefore the briefing document should have been more detailed and prescriptive in how to answer such questions in-line with the requirements of the Code. The Panel considered this was a contributing factor to the answer given by the global senior leader which had resulted in the pre-licence promotion of orforglipron. The Panel concluded that Lilly had failed to maintain high standards and ruled a breach of Clause 5.1.
Upholding confidence in the industry (Clause 2)
Clause 2 was a sign of particular censure and was reserved for such use. The supplementary information to Clause 2 listed promotion prior to the grant of a marketing authorisation as an example of an activity likely to be in breach of Clause 2.
However, the Panel noted that it was obliged to make its rulings based on what the company’s global senior leader had actually stated rather than the edited published article and that the questions on orforglipron had been unsolicited and made up a minority of the interview. In the circumstances of this case, the Panel did not consider the overall content of the interview in question met the threshold for bringing discredit upon, or reducing confidence in, the pharmaceutical industry. The Panel was satisfied, on balance, that its rulings of a breach of Clauses 3.1 and 5.1 were sufficient in relation to this matter and therefore ruled no breach of Clause 2.
