Ceramex has withdrawn from the UK’s Pharmaceutical Marketing Self-Regulatory Programme, after it was found to have brought discredit to the industry twice in quick succession.
The pharmaceutical self-regulatory body PMCPA ruled last year that Theramex’s “systemic deficiencies in compliance oversight” had damaged the industry’s credibility. The PMCPA asked the Appeals Board to consider whether to impose further sanctions on Theramex. Late last week, the PMCPA revealed that Ceramex had withdrawn from self-regulation before the appeals board could discuss the matter.
Ceramex’s actions were “extremely disappointing and demonstrated that it does not accept responsibility for these failures within its self-regulatory framework,” PMCPA said. Because there was no evidence that Ceramex had acted to address PMCPA concerns, the appellate panel publicly reprimanded the company and said it needed to undergo an audit to return to self-regulation.
In an emailed statement, a Ceramex spokesperson said the company had “resolved the issues raised and initiated significant updates and improvements to its processes and procedures beyond those required by the PMCPA” by April 2025. A spokesperson said the measures included a comprehensive review of its compliance framework, including commissioning an independent external audit.
As part of that process, Theramex concluded that it was “best suited to be regulated by the MHRA in terms of UK medicines law, while maintaining the spirit and principles of the EFPIA and ABPI codes of practice”. Ceramex said the withdrawal was a way to “focus our resources on maintaining high standards of ethical and compliant conduct with patient safety as our top priority.”
The appeals board argued that the revocation was a “departure from its self-regulatory responsibility” to public safety. By assigning UK regulator MHRA responsibility for overseeing the company, Ceramex “necessarily delayed all regulatory action and oversight”, the appeals panel said.
The PMCPA announced the results of the appellate board process, along with the results of a separate case against Theramex. In investigating the incident that led to the national disciplinary action, the PMCPA followed up on a complaint that Ceramex provided misleading information about the company’s uterine fibroid drug Iserty at a reproductive and embryology conference.
A PMCPA panel ruled that Theramex brought the industry into disrepute by promoting the GnRH antagonist at an event without making its contraindications during pregnancy “sufficiently clear.” The PMCPA said it was “difficult to understand why” Ceramex thought this promotion was appropriate, adding that “[Iserti’s]status as a black triangle drug compounded this serious error.”
Ceramex admitted breaching Article 5 of the UK Marketing Code, but appealed on the grounds that this fact had caused a loss of confidence in the industry. The company cited medical consultants who said the fertility experts who attended the event were familiar with GnRH antagonists and would have known that they should not be used during pregnancy.
The Appeals Committee disagreed, concluding that “it cannot be assumed that all those present had this knowledge.” The board also noted that the drug’s mechanism of action was not described on the display. The Board affirmed the PMCPA’s decision, believing that the lack of contraindication information was misleading and unacceptable.
Ceramex withdrew from self-regulation following this decision, joining a short list of companies that have left PMCPA jurisdiction in recent years. Sands withdrew in 2023 after disagreements with PMCPA over allegations of misleading drug advertising. Evolus withdrew last year.
