AbbVie: Rinvoq webinar registration page and omission of grapefruit warning (AUTH/3834/10/23) – No breach

📅 2023 | 🖉 Dr Anzal Qurbain
📊

Key facts

Case numberAUTH/3834/10/23
CompanyAbbVie
ComplainantHealth professional (as described by complainant)
ProductRinvoq (upadacitinib)
MaterialWebinar registration webpage for UK HCPs (on-demand promotional content; “Clear Horizons” series)
Main allegationOmission of SmPC grapefruit avoidance statement from a page that included dosing information
Applicable Code year2021
Clauses considered2, 5.1, 6.1
Panel decisionNo breach of Clauses 2, 5.1, 6.1
Voluntary admissionClause 8.1 (Failure to certify material in its final form) – Panel made no ruling in this case (noted as considered in AUTH 3852/11/23)
Complaint received9 October 2023
Case completed6 September 2024
AppealNo appeal

Download the full case report (PDF)


Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI
📋

What happened

  • A health professional complained about an AbbVie webinar registration webpage for UK HCPs to access on-demand promotional content in the “Clear Horizons” series (Rinvoq/upadacitinib; atopic dermatitis-focused content).
  • The complainant alleged the page included dosing information but omitted the SmPC statement: “Food or drink containing grapefruit should be avoided during treatment with upadacitinib (see section 4.5).”
  • The complainant argued this omission could risk patient safety and was particularly important because Rinvoq was described as a black triangle product.
  • AbbVie said the page’s purpose was registration (not a complete prescribing/safety resource), and it prominently provided a single-click link to prescribing information plus signposting to the SmPC.
  • AbbVie also stated (context) that the grapefruit warning relates to increased exposure with strong CYP3A4 inhibitors; co-ingestion is not listed as a contraindication in SmPC section 4.3.
  • AbbVie made a voluntary admission that the hosted page was not the correctly certified final form due to an agency uploading an incorrect version with the same job code; however, this certification issue was considered in a separate case (AUTH 3852/11/23).
⚖️

Outcome

  • No breach of Clause 6.1 (Requirement that claims/information/comparisons must not be misleading).
  • No breach of Clause 5.1 (Requirement to maintain high standards at all times).
  • No breach of Clause 2 (Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry).
  • The Panel noted the voluntary admission about certification was dealt with in Case AUTH 3852/11/23 and made no ruling on it in this case.
🔒

Unlock the full case analysis

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value
£249/year
Annual — save £99
or
£29/mo
Monthly
Join Now — Instant Access

⭐ Charter Member — Until 31 March

See the full compliance picture for every pharma company

291 Company Intelligence Reports — breach patterns, appeal history, industry ranking, PDF export. £1,999/year £2,499

Get Charter Access →

📰 Weekly PMCPA Case Breakdown

One real case. One key lesson. Every week — free.

Subscribe Free