Some slap-downs from the PMCPA hit harder than others. The U.K. drug marketing body twisted the knife in its latest ruling against Otsuka, accusing the drugmaker of an unacceptable failure “to provide a full and frank disclosure.”
The PMCPA made the statement after investigating a complaint from someone who worked at Otsuka at the time of an earlier investigation by the marketing body. Otsuka submitted three unsigned statements as part of its response to an earlier complaint that the PMCPA ruled on in 2015. Eight years later, one of the people who provided an unsigned statement filed a complaint with the marketing body.
According to the latest complaint, Otsuka blocked the three people from seeing the final statements it filed on their behalf. The complainant believed Otsuka removed “vital information” from their statement and said the company received details of a potential code breach before the PMCPA got involved.
“The complainant alleged that this complaint was never investigated and was ‘brushed under the carpet’ and this was never mentioned in any of the documents submitted to the PMCPA. The complainant believed that the company tried to cover this up,” the PMCPA said. The complainant and colleagues were allegedly seen as whistleblowers and pushed out of the company.
Otsuka was unable to locate documents related to the 2015 case and, with its U.K. head office employing no staff who were around back then, found the complaint extremely difficult to investigate. Ultimately, the company was given a copy of its response letter and enclosures, leading to evidence the issue had been raised internally before the PMCPA complaint.
The PMCPA ruled “the witness statements did not reflect the full content of the interviews” and that Otsuka should have included details of its prior knowledge of the incident in its response to the original complaint. Viewing full and frank disclosure of all the facts as essential to self-regulation, the panel ruled Otsuka’s lack of transparency brought discredit on the pharma industry.
The panel was “concerned and disappointed [by] ... another example of Otsuka not being transparent in its response to the PMCPA.” Ordinarily, the panel would have responded to the failings by reporting Otsuka to the Code of Practice Appeal Board. The board can reprimand reported companies, require an audit of their procedures and tell them to issue a corrective statement.
However, the lag between the offenses and the complaint saved Otsuka. The panel noted the PMCPA had audited Otsuka between 2019 and 2022 and considered the company’s submission “that there had been substantial changes since 2015 to its leadership, employees, compliance programme, governance oversight, operations and whistleblowing procedures.” Those factors informed the choice not to report.