The PMCPA ruled that “a systemic failure in compliance oversight” at Theramex has brought discredit on the industry, prompting the U.K. pharma marketing watchdog to consider additional sanctions against the company.
Theramex is a women’s health company that sells products including the vulvar and vaginal atrophy drug Intrarosa and the hormone replacement therapy range Evorel. The PMCPA began investigating the company last year after receiving a complaint on behalf of “a group of employees from various cross-functional teams at Theramex.”
The complaint said “some products, such as Intrarosa, have not had their prescribing information updated since 2019, leaving us concerned that important safety data may have been omitted from our portfolio of drugs due to a lack of interdepartmental accountability.” Efforts to escalate issues internally were met with “a consistent lack of action or meaningful response,” per the complaint.
After being contacted by the PMCPA, Theramex said the information for Intrarosa and the Evorel range had “undergone a thorough review and regular updates” but admitted that at one time the information was “updated after a year, which is unacceptable.”
Considering those failings and other issues, the company accepted a breach of Clause 2 of the PMCPA’s code, and the regulator agreed that Theramex had indeed discredited the pharma industry.
“The failings reflected either a complete lack of awareness of the requirements of the Code or a profound misunderstanding of its application,” the PMCPA said. “For such serious breaches to have occurred, and for them to have gone undetected and unremedied over a prolonged period, was wholly unacceptable and indicated a systemic failure in compliance oversight.”
The PMCPA reported Theramex to its appeal board, which can impose further sanctions. At a meeting of the appeal board, representatives of the company “fully acknowledged and accepted accountability for the compliance failings,” adding that the failures “reflected deeper deficiencies in internal processes and governance structure,” the PMCPA said.
Theramex told the appeal board that it had started an external compliance audit and taken preventive actions, changes, training and process improvements.
While the board said it was “very concerned about the fundamental compliance errors,” it deferred a decision about whether to impose further sanctions to a meeting scheduled for December.
The board has asked a senior representative of Theramex to attend the meeting to discuss the “scope and outputs from the external compliance audit and any staff survey results, together with a detailed compliance action plan to address any issues identified, including dates and timescales.”