CASE AUTH/3905/5/24 NO BREACH OF THE CODE
COMPLAINANT v ORGANON
Allegations regarding missing safety information in a Nexplanon advertisement
CASE SUMMARY
This case was in relation to an advertisement for Nexplanon that appeared on the website of a closed community professional network for doctors in the UK. The complainant alleged that the advertisement did not mention significant facets of the treatment. The complainant referred specifically to (i) the product increasing the risk in certain patients with an increased risk of cancer and (ii) the contraindications in the summary of product characteristics. The complainant further alleged that the advertisement provided a link to a webpage which also did not refer to the contraindications.
The outcome under the 2021 Code was:
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No Breach of Clause 2
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Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
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No Breach of Clause 5.1 (x2)
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Requirement to maintain high standards at all times
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No Breach of Clause 6.1 (x2)
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Requirement that information/claims/comparisons must not be misleading
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No Breach of Clause 6.2 (x2)
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Requirement that information/claims/comparisons must be capable of substantiation
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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 about Organon UK was received from an anonymous, contactable complainant who described themselves as a concerned healthcare professional.
COMPLAINT
The complaint wording is reproduced below:
“The following advert is present on [URL provided].
This advert does not mention clinically significant facets of the treatment which would alter who would be prescribed – including that the product could increase the risk in certain patients with an increased risk of cancer.
For your convenience, the below are from the SPC:
4.3 Contraindications
• Active venous thromboembolic disorder.
• Known or suspected sex steroid sensitive malignancies.
• Presence or history of liver tumours (benign or malignant).
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
• Undiagnosed vaginal bleeding.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Links through to [the Nexplace website] which also fails to mention these significant contraindications.
Given this clear infringement of patient safety, please investigate.”
When writing to Organon, the PMCPA asked it to consider the requirements of Clauses 6.1, 6.2, 5.1 and 2 of the 2021 Code.
ORGANON’S RESPONSE
The response from Organon is reproduced below:
“We are writing in response to the complaint received under Case AUTH/3905/5/24 regarding alleged missing safety information in the Nexplanon advertisement on [URL and job code provided]. At Organon, we are committed to the highest ethical and regulatory standards, and patient safety is at the core of everything we do. We take this complaint very seriously and appreciate the opportunity to address the healthcare professional's concerns.
We have conducted a thorough internal review to fully understand the complaint and ensure our response is comprehensive and accurate.
Commitment to Ethical Standards
Organon is dedicated to upholding the highest level of ethical and regulatory standards. We are deeply committed to earning and maintaining the trust of our patients and healthcare professionals. We take any complaints, especially those involving patient safety, extremely seriously. As ABPI members, our goal is to ensure that all information disseminated to healthcare professionals meets the ABPI Code’s requirements, thereby enabling informed prescribing decisions whilst also maintaining patient safety.
Review of the Advertisement
The advertisement in question presents two claims about Nexplanon. It mentions that it is the only sub-dermal contraceptive implant available in the UK, and it highlights the efficacy and convenience of this contraceptive method, substantiated by reference to the Nexplanon Summary of Product Characteristics (SmPC). The complainant has stated that the advertisement does not mention ‘clinically significant facets of the treatment’, specifically referring to Nexplanon’s contraindications. We believe that the concise information provided in this particular advertisement serves its intended purpose without the need to reference contraindications explicitly, please see further explanation below.
• Clauses 6.1 and 6.2: There is no explicit requirement in the ABPI Code of Practice to include contraindications in all promotional materials. The inclusion of such details depends on the context, including the material's content, layout, audience, and intended use.
• Clause 5.1: The material in question includes a link to the full prescribing information (PI) and Summary of Product Characteristics (SmPC), providing one-click access to all relevant safety information, including contraindications.
• Clause 2: We believe the advertisement maintains a high standard of ethical promotion and does not mislead or imply that Nexplanon can be used in all patient populations, regardless of their medical history. Importantly, we have not advocated the use of Nexplanon in populations or sub-populations mentioned in the contraindications, nor implied that it can be used in all patients regardless of their medical background. Therefore, we believe there is no requirement to include the contraindications on this particular advertisement. Furthermore, given that the target audience of the advertisement is healthcare professionals, and there is a clear reference to and availability of the SmPC and PI, we do not believe that this advertisement has compromised on patient safety in any way.
Contextual Justification
The advertisement is a small, single-frame piece designed to provide succinct information about Nexplanon’s availability and efficacy. Given the limited space, we have tailored the promotional content to convey essential messages without the need to include additional context in the form of safety information. This approach allows us to maintain the clarity and impact of the advertisement while ensuring comprehensive safety information is readily accessible through the provided PI and SmPC links.
Addressing the Complainant's Concerns
The complainant's concern about missing ‘clinically significant facets of the treatment,’ specifically contraindications, is noted. However, the principle upheld by the panel in previous PMCPA cases is that the necessity to highlight contraindications depends on the specific circumstances, not a blanket requirement for all promotional materials. As noted in historic PMCPA code case (AUTH/3633/4/22):
‘The panel considered that whether a contraindication needed to be highlighted within a particular section of promotional material, in addition to its requirement to be included within the prescribing information that was required on all promotional materials, depended on a consideration of all circumstances including the nature of the contraindications, layout, audience, and intended use of the material.’
In our case, the advertisement directs healthcare professionals to detailed prescribing information, fulfilling the relevant ABPI code requirements. Also, considering its nature and content, it is not necessary to include the contraindications on this particular advertisement.
Website Information
Regarding the Nexplace website, the content available before login is intentionally limited to basic information about Nexplanon's sub-dermal nature and its three-year efficacy. This is why there is no mention of contraindications at this initial stage. However, once healthcare professionals log in, they gain access to further safety information, including contraindications. This ensures they have the necessary context for informed prescribing decisions. The logged-in section provides extensive information about Nexplanon, where the inclusion of contraindication information is relevant.
Supporting Documents
Attached, please find [enclosures provided].
Conclusion
Organon remains dedicated to maintaining a robust compliance culture and ensuring that all promotional materials meet the ABPI Code's requirements. On this occasion, we refute the allegations and as a result, deny breaches of clauses 6.1, 6.2, 5.1, and 2. We trust that our comments and the enclosed documents demonstrate our commitment to ethical promotion and patient safety. We look forward to your response and are available to provide any additional information required.
Thank you for bringing this matter to our attention.”
PANEL RULING
This complaint about Organon was received from a complainant who described themselves as a concerned health professional. The complaint related to an advertisement for Nexplanon that appeared on the website of a closed community professional network for doctors in the UK. The complainant provided a screenshot of the advertisement and alleged, among other things, that “it did not mention significant facets of the treatment”. The complainant listed the contraindications in the summary of product characteristics (SPC) and also alleged that the advertisement linked through to a webpage which “also fails to mention these significant contraindications”.
The Panel noted the following information from the Nexplanon SPC.
Section 4.1, Therapeutic Indications, stated:
“Contraception.
Safety and efficacy have been established in women between 18 and 40 years of age.”
Section 4.3, Contraindications, listed the following:
• “Active venous thromboembolic disorder.
• Known or suspected sex steroid sensitive malignancies.
• Presence or history of liver tumours (benign or malignant).
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
• Undiagnosed vaginal bleeding.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.”
Section 4.4, Special Warnings and Precautions for Use, listed various warnings and precautions, and stated:
“If any of the conditions / risk factors mentioned below is present, the benefits of progestagen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start with Nexplanon. In the event of aggravation, exacerbation or first appearance of any of these conditions, the woman should contact her HCP [healthcare professional]. The HCP should then decide on whether the use of Nexplanon should be discontinued.”
In relation to Liver Disease, Section 4.4 stated:
“When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.”
In relation to Thrombotic and Other Vascular Events, Section 4.4 stated, among other things:
“The clinical relevance of these findings for etonogestrel (the biologically active metabolite of desogestrel) used as a progestagen-only contraceptive in the absence of an oestrogenic component is unknown.
Limited epidemiological data do not suggest an increased risk of VTE [venous thromboembolism] or ATE [arterial thromboembolism] in women using the implant; however, there have been postmarketing reports of VTE and ATE, in women using etonogestrel implants. It is recommended to assess risk factors, which are known to increase the risk of VTE and ATE.
Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. The implant should be removed in the event of a thrombosis. Removal of the implant should also be considered in the case of long-term immobilisation due to surgery or illness.”
Section 4.4 further stated:
“Prior to the initiation or reinstitution of Nexplanon a complete medical history (including family medical history) should be taken and pregnancy should be excluded. Blood pressure should be measured and a physical examination should be performed, guided by the contraindications (see section 4.3) and warnings (see section 4.4). It is recommended that the woman returns for a medical check-up three months after insertion of Nexplanon.”
The Panel acknowledged that Clause 6.1 of the Code did not require expressly for contraindications to be included in materials. However, Clause 6.1 did require that information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous, that they must not mislead and that material must be sufficiently complete to enable recipients to form their own opinion of the therapeutic value of the medicine. Further, the Supplementary Information to this clause required that claims in materials must be capable of standing alone as regards accuracy, etc.
The Panel considered that whether a contraindication needed to be highlighted within promotional material, in addition to the requirement for it to be included within the prescribing information that was required on all promotional material, depended on a consideration of all the circumstances. This would include taking account of the therapy area, the nature of the contraindication, as well as the content, layout, audience and intended use of the material.
The Advertisement
The complainant alleged that the advertisement did not include “clinically significant facets of the treatment which would alter who would be prescribed, including that the product could increase the risk in certain patients with an increased risk of cancer”. The complainant referred specifically to the contraindications in the SPC.
The advertisement consisted mostly of text, alongside a very small image of three women. It contained:
1. A title, asking: “Are your patients looking for a long-acting reversible contraceptive implant?”
2. One sentence describing the product: “NEXPLANON (etonogestrel) is the only subdermal contraceptive implant available in the UK, and offers effective and convenient contraception that works around your patients’ lifestyles, not against them.1”
3. A statement that this was “Promotional information from Organon.”
4. A link labelled “Learn more (external link) >” in bold text.
5. A link to the prescribing information.
6. An adverse events reporting statement.
7. A link to the summary of product characteristics: “Reference: 1. NEXPLANON SPC”
8. The job code, date of preparation and copyright statement.
The advertisement did not include any contraindications for Nexplanon, or other safety information.
The Panel noted that the advertisement included a claim that described Nexplanon as “the only subdermal contraceptive implant available in the UK”, that it was “effective and convenient” and that it worked around patients’ lifestyles.
The Panel noted from the metadata of the advertisement and the statement of work made between Organon and the named company which supported the advertisement’s dissemination, that the advertisement was a short piece of text directed to opted-in target audience members of general practitioners (GPs) and genitourinary medicine specialists (GUM specialists) to facilitate external traffic driving to the Nexplace website. The Panel noted that the advertisement was part of a clinical bulletin which was sent at least twice a month to the opted-in target audience members in the UK only. The metadata further stated that if users were logged-in they would see the logged-in view of Nexplace; if not, they would only see the logged-out view which had some pages restricted.
Given that the advertisement was directed to a specific audience of GPs and GUM specialists, the Panel considered that, on the balance of probabilities, the target audience would be:
1. aware that all contraceptives had contraindications,
2. familiar with the well-defined guidelines which existed for prescribing contraceptives,
3. likely to exercise caution before prescribing contraceptives to the relevant patient population, and
4. unlikely to rely on a brief advertisement alone, without further research, to make a prescribing decision.
The Panel noted Organon’s submission that the advertisement included a link to the full prescribing information and SPC, providing one-click access to all relevant safety information, including contraindications.
The Panel considered that, provided the material complied with the Code and was not misleading, it was not always necessary to include detailed safety data in an advertisement.
The Panel considered that in the particular circumstances of this case, noting the therapy area of contraception, the target audience, and noting the above, the advertisement did not imply that there were no contraindications or safety considerations for Nexplanon. In the Panel’s view, the complainant had not established that the advertisement was misleading or incomplete because the list of contraindications was not included in the body of the advertisement, and the Panel ruled no breaches of Clauses 6.1, 6.2 and 5.1 accordingly.
The Linked Website
The advertisement included an external link, in bold font, to “Learn More”. Upon clicking the link, readers would arrive at the homepage for the Nexplace website. The complainant alleged that this webpage “also fails to mention these significant contraindications”. The Panel noted that if users were not already logged in to the Nexplace website, they would see the ‘pre-login homepage’.
The pre-login homepage for the Nexplace website contained:
1. A coloured banner near the top of the webpage containing the indication for Nexplanon, immediately preceded by a link to prescribing information, in bold text.
2. Claims about the subdermal nature of Nexplanon and its efficacy in clinical studies, followed by a prominent button to Login/Register to access training and development resources, patient support materials and more.
3. A Contact Us button to contact a local representative from Organon for more information.
4. A button to Login/Register to join the Nexplace community to get access to Nexplanon training and resources.
5. The adverse events reporting statement and, beneath a heading of “Supporting documentation”, links to the Nexplanon prescribing information, SPC and patient information leaflet.
The pre-login webpage did not include the contraindications for Nexplanon. The Panel noted Organon’s submission that the content available before login was intentionally limited to basic information about Nexplanon's sub-dermal nature and its three-year efficacy.
The Panel noted that if users logged in to the Nexplace website, they would see the post-login homepage, which included the same banner near the top of the webpage with the indication for Nexplanon and a link to prescribing information, in bold text. The page included the same claims about the subdermal nature of Nexplanon and its efficacy in clinical studies as appeared on the pre-login homepage. Beneath this information, the post-login webpage contained additional information in short sections under the following headings: “What is Nexplanon?”, “Who is Nexplanon for?”, “Where is Nexplanon inserted?”, “How to insert Nexplanon”, “How to remove Nexplanon”, “Not trained to fit Nexplanon?” and “FSRH Training”. Below these short sections was a Contact Us button to “Contact your local Organon Representative”, the adverse events reporting statement and the “Supporting documentation” section with links to prescribing information, the SPC and the patient information leaflet.
The Panel noted that the second section on the post-login homepage, titled “Who is Nexplanon for?”, listed the following contraindications from Section 4.3 of the Nexplanon SPC:
• Active venous thromboembolic disorder.
• Known or suspected sex steroid sensitive malignancies.
• Presence or history of liver tumours (benign or malignant).
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
• Undiagnosed vaginal bleeding.
• Hypersensitivity to the active substance or to any of the excipients.
The Panel noted that adjacent to the list of contraindications, there was a short paragraph in a similar sized font, stating: “The benefits of progestogen use should be weighed against the possible risk for each individual woman and should be discussed with the woman before she decides to start with NEXPLANON. Please refer to the NEXPLANON Summary of Product Characteristics for a full list of warnings and precautions for use1”. The footnote referred to the Nexplanon SPC, listed near the bottom of the webpage.
The Panel considered the immediate impression to a health professional who would have clicked on “Learn more” on the advertisement at issue and arrived at the pre-login Nexplace homepage. The Panel relied upon its comments above regarding the target audience of the advertisement being GPs and GUM specialists who were likely to be familiar with the well-defined guidelines which existed for the prescribing of contraceptives, would be aware that all contraceptives had contraindications, and would exercise caution when prescribing contraceptives to the relevant patient population.
In the Panel’s view, the purpose of the pre-login homepage was to provide readers with a basic overview of Nexplanon, and to direct readers to login or register to gain access to training and development resources and patient support materials.
The statement “NEXPLANON (etonogestrel 68mg implant) is indicated for contraception. Safety and efficacy have been established in women between 18 and 40 years of age.” was included at the top of the pre-login webpage. The Panel considered that it was clear that this was the wording of the indication for Nexplanon and that it did not imply that Nexplanon could be used in all women between 18 and 40 years of age. While the Panel considered that it may have been helpful to include the contraindications on the pre-login homepage, in the Panel’s view, the content of the webpage did not misleadingly imply that Nexplanon had no contraindications or safety considerations. Further, a prominent link to the prescribing information was included, adjacent to the indication, and the post-login webpage contained further safety information, including the list of contraindications.
The Panel considered that, in the particular circumstances of this case, the complainant had not established that it was misleading to not include Nexplanon’s contraindications on the pre-login homepage, and the Panel ruled no breaches of Clauses 6.1, 6.2 and 5.1.
Overall
Clause 2 was a sign of particular censure and was reserved for such use. Noting its rulings of no breaches above, the Panel ruled no breach of Clause 2.
Complaint received 15 May 2024
Case completed 18 February 2025
