Otsuka is once again on the PMCPA’s naughty list as the U.K. drug marketing regulatory body has for the second time this year found the Japanese pharma guilty of its most serious code breach.
The first time was just three months ago when the PMCPA, which polices drug marketing rules in the U.K., accused the drugmaker of an unacceptable failure “to provide a full and frank disclosure” on an old case and found it guilty of breaching Clause 2 of its Code, the most serious breach.
Now it’s back in the dock again with another breach of Clause 2: “bringing discredit upon, and reducing confidence in, the pharmaceutical industry”.
This time the pharma was hit by an accusation, upheld by the PMCPA, by a former employee that centered on instructions on a prescription drug training website and the omission of information in one of the documents on that site.
That drug is Jinarc, Ostuka’s kidney disease therapy, and the PMCPA found that Otsuka had not properly and within the confines of the Code laid out all the necessary special warnings and precautions for use on the educational guide for the med.
This was true for the website and a hard copy of the guide, intended for healthcare professionals.
The PMCPA found that Otsuka had specifically “omitted important information related to treatment discontinuation if renal insufficiency progresses to CKD stage 5.” This saw Otsuka breach three clauses, including Clause 2; no surprise, given that the PMCPA has no wriggle room regarding safety messaging.