Every case here is turned into an approval-ready lesson: risk signal → breach → root cause → control → what to check next time.
Practical, no-fluff breakdowns of PMCPA rulings
“What good looks like” under the ABPI Code
Common failure points (claims, meetings, digital, disclosures)
The control that would have prevented the breach
Job-bag checks you can copy into your SOPs
Fast, practical read — written by an ABPI Final Signatory
Need rapid support this week? I take on short signatory/medical review blocks.
Six complaints against AstraZeneca. Breaches found for a UK meeting treated as non-promotional (certification/PI and ‘cure’ claims) and for LinkedIn engagement promoting an unlicensed medicine and a POM to the public.
A UCB employee’s personal LinkedIn profile described work on Phase 3 axial spondyloarthropathy for bimekizumab. The Panel ruled this promoted an unlicensed medicine and was not certified, breaching Clauses 3.1, 14.1 and 9.1.
Bristol-Myers Squibb admitted a promotional article misquoted 30‑month overall survival figures for intermediate/poor-risk aRCC by using ITT data. The online article was removed and a corrected reprint with apology was issued.
AstraZeneca admitted an employee re-tweeted positive clinical-trial-related posts about Forxiga and a Lynparza news tweet from a personal account. The Panel found promotion of unlicensed indications, advertising POMs to the public, and lack of certification.
Vifor’s corporate website displayed inverted triangle symbols in blue/grey/white (not black) on IV iron product pages and mixed public and HCP information without separation. The site was deactivated and brand information removed.
A GP challenged an Eliquis leavepiece claiming no dose adjustment in mild/moderate renal impairment. The PMCPA found the page misleading versus the SPC, upheld breaches including Clause 2, and rejected the Alliance’s appeal on standards/discredit.
Following BBC criticism, the PMCPA assessed a Napp-sponsored New York meeting for UK pain specialists. The Panel found breaches relating to overseas venue justification and entertainment/hospitality, including Clause 2 discredit.
An anonymous employee complained that Otsuka UK webpages listed POM brand/generic names and indications. The Panel ruled the pages promoted POMs to the public and were not access-restricted, breaching Clauses 26.1, 26.2, 28.1 and 9.1.
Boehringer Ingelheim admitted that June 2019 MIMS carried a Spiolto Respimat full-page ad plus a double-sided bookmark insert, exceeding the two-page limit for a single product in a print journal.
