Theramex has opted out of the U.K.’s self-regulatory program for pharma marketing after being found to have brought discredit on the industry twice in quick succession.
Pharma self-regulatory body the PMCPA ruled last year that Theramex’s “systemic failure in compliance oversight” had brought discredit on the industry. The PMCPA asked its appeal board to consider whether to impose further sanctions on Theramex. Late last week, the PMCPA revealed that Theramex withdrew from self-regulation before the appeal board met to discuss the case.
Theramex’s action was “extremely disappointing and evidenced a failure to take responsibility for these failures within the self-regulatory framework,” the PMCPA said. Lacking any evidence that Theramex had acted to address the PMCPA’s concerns, the appeal board publicly reprimanded the company and said it will need to undergo an audit to rejoin self-regulation.
In an emailed statement, a Theramex spokesperson said that by April 2025, the company “had resolved the matters raised and initiated substantial updates and improvements to our processes and procedures, beyond those required by the PMCPA.” The actions included a comprehensive review of the compliance framework, including commissioning an independent external audit, the spokesperson said.
As part of the process, Theramex concluded “It is most appropriate to be regulated with respect to U.K. medicines legislation by the MHRA, while continuing to uphold the spirit and principles of the EFPIA and ABPI Codes of Practice.” Theramex framed the withdrawal as a way to “focus resources on maintaining high standards of ethical and compliant behavior, with patient safety paramount.”
The appeal board called the withdrawal a “derogation of responsibility under self-regulation” to public safety. By making the U.K. regulatory agency, the MHRA, assume responsibility for overseeing the company, Theramex “has inevitably delayed any regulatory action and oversight,” the appeal board said.
The PMCPA published the outcome of the appeal board process alongside the results of another case against Theramex. While investigating the case that led to the public reprimand, the PMCPA followed up on a complaint that Theramex provided misleading information about its uterine fibroid drug, Yselty, at a reproduction and embryology conference.
A PMCPA panel ruled that Theramex brought discredit on the industry by promoting the GnRH antagonist at the event without making its contraindication in pregnancy “abundantly clear.” The PMCPA said it is “difficult to understand why Theramex considered” the promotion appropriate, adding that “this serious error was compounded by [Yselty] being a black triangle medicine.”
Theramex accepted breaches of five clauses of the U.K. marketing code but appealed the finding that it brought discredit on the industry. Citing its medical consultant, the company said the fertility specialists who attended the event would have been very familiar with GnRH antagonists and would have known that they shouldn’t be used during pregnancy.
The appeal board disagreed, concluding that “it was inconceivable that all attendees would have this knowledge.” The board also noted that the drug’s mechanism of action wasn’t stated on the exhibition stand. Believing the lack of contraindication information to be misleading and unacceptable, the board upheld the PMCPA’s ruling.
Theramex withdrew from self-regulation after receiving the decision, joining a short list of companies that have left the PMCPA’s jurisdiction in recent years. Sandoz withdrew in 2023 after disagreeing with the PMCPA about allegations of misleading drug promotion. Evolus withdrew last year.