GSK has been found guilty of bringing discredit on the pharma industry after a complainant flagged “a shocking error” in the prescribing information for the JAK inhibitor Omjjara.
A person who self-identified as a health professional wrote to the PMCPA, the body that oversees the U.K. marketing code, after finding fault with prescribing information for Omjjara. The drug is contraindicated in pregnancy, and the line that startled the complainant says, “Women using oral hormonal contraceptives should add a barrier method during treatment and for at least 1 week after the last dose of Omjjara.”
According to the complainant, “common sense and reasoning suggests any non-oral hormone contraception will raise the same concern,” leading them to “query the ability of GSK to accurately produce prescribing information and query whether sufficient checks have been made to these items prior to release.”
GSK defended the wording of the prescribing information and its processes. The company denied it had breached the code, arguing that the line was taken verbatim from part of the summary of product characteristics, which had been approved by the licensing authority.
A GSK spokesperson said: “We take adherence to industry codes and regulations very seriously. We are committed to upholding the highest standards of integrity and ethical conduct in all aspects of our business. Our focus is always on ensuring the well-being of patients and maintaining trust in our industry”
The PMCPA panel accepted that two sections of the summary refer to oral hormonal contraceptives, the same wording that GSK used in the prescribing information. Yet, the panel also noted that the wording is different in another section of the summary: The section about fertility, pregnancy and lactation refers to “systemically acting hormonal contraceptives.”
A healthcare professional would expect the prescribing information on contraceptives to fairly reflect the section of the summary about fertility, pregnancy and lactation, the PMCPA said. The panel concluded that GSK’s wording was misleading because it implied only those women using oral hormonal contraceptives would need to add a barrier method. That implication is inconsistent with the summary, the panel said.
Having reached that conclusion, the panel found that GSK had broken the rule against producing misleading information. In considering whether GSK had failed to maintain high standards, the panel found that the company had produced that misleading information despite following a process for creating and certifying the materials, and therefore had indeed failed to maintain high standards.
The PMCPA delivered a final blow to GSK by ruling that it had brought discredit on the industry, a finding that it reserves for particularly severe transgressions. The breach of Clause 2 of the U.K. marketing code, according to the panel, reflected its finding that GSK had provided misleading information about a medicine that is subject to additional monitoring and contraindicated in pregnancy because it may cause fetal harm.