HRT maker censured by UK regulator for ‘systemic failures’ that put patients at risk
One of the biggest producers of hormone replacement therapy has been censured by regulators for “systemic failures” that jeopardised patient safety.Theramex, the UK producer of HRT drugs Evorel and Intrarosa, was found to have breached fundamental compliance standards including not updating crucial prescribing information – in some cases for several years – and not making it clear that a drug must not be used during pregnancy.The Prescription Medicines Code of Practice Authority (PMCPA), the UK drug industry’s self-regulatory body, issued the public reprimand against Theramex after its own staff blew the whistle over “alarming” compliance issues and incomplete prescribing information for Evorel and Intrarosa that “jeopardise patient safety”.Evorel patches – which contain estradiol – are among the most prescribed form of transdermal HRT, with more than 250,000 items issued in the last financial year, according to NHS Business Services Authority figures.Overall, nearly 10m items of estradiol, including gels, were prescribed in the 2024/25 financial year.
The employees’ concerns included failing to provide comprehensive side-effect information in Evorel’s prescribing information, and not updating Intrarosa’s product information since 2019.The PMCPA also reprimanded the company for failures to specify in its advertising at a reproduction and advertising conference that Yselty (linzagolix), used to treat uterine fibroids, should not be taken during pregnancy.In all, PMCPA found that Theramex breached the Association of the British Pharmaceutical Industry (ABPI)’s code of practice 21 times.The panel said these breaches not only jeopardised patient safety, but that Theramex has “brought discredit upon, and reduced confidence in, the pharmaceutical industry”.The PMCPA also condemned Theramex’s decision to leave the regulator’s jurisdiction.
“By leaving the self-regulatory framework and requiring the Medicines and Healthcare products Regulatory Agency (MHRA) to assume full responsibility for regulating it, Theramex has inevitably delayed any regulatory action and oversight,” it said.Dr Amit Aggarwal, medical director of the ABPI, said: “[Theramex] has fallen seriously short of the standards expected under our strict ABPI code of practice, and it’s right that the PMCPA took action.“It’s also disappointing that as a result, the company has decided to leave the pharmaceutical industry’s self-regulatory system, which holds companies to standards above and beyond the law.”Julian Beach, MHRA’s executive director of healthcare quality and access, said he was disappointed Theramex had left PMCPA but that MHRA would taken any necessary steps to ensure patient safety.“Leaving the jurisdiction of the PMCPA does not mean a company escapes scrutiny.
The MHRA has legal powers … to investigate and act on concerns about medicines that may impact public safety.Breaches of regulations can amount to criminal offences.”A spokesperson for Theramex said: “Upholding ethical standards, compliance, and patient safety is very important to us.We acted promptly to address these historical matters as soon as we became aware of them.“We take these matters seriously and have undertaken a comprehensive review of our compliance framework, including commissioning an independent external audit and implementing a broad programme of enhancements.
“As part of this process, we concluded it is most appropriate to be regulated with respect to UK medicines legislation by the MHRA, while continuing to uphold the spirit and principles of the EFPIA [European Federation of Pharmaceutical Industries and Associations] and ABPI codes of practice.“Therefore, we withdrew from the PMCPA’s jurisdiction in January 2026.This approach allows us to focus our resources on maintaining high standards of ethical and compliant behaviour, with patient safety paramount.”
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