Astellas’ U.K. unit was already suspended from the Association of the British Pharmaceutical Industry thanks to what the trade group last year called “serious breaches” of its code of practice. And now, that suspension has been extended.
The organization has tacked another 12 months onto Astellas’ penalty, it said Friday, citing cases that “have shown wholly inadequate oversight and control at both Astellas UK and Astellas Pharma Europe and a 'lamentable lack of concern for patient safety.'” And the re-suspension very nearly became an expulsion, it noted.
The extra 12 months come in response to three new cases that Astellas voluntarily served up over the course of audits this April and last September. One case “highlighted a lack of oversight and training of agency nurses who delivered patient support programs, including failing to update them with product changes,” the ABPI said. Two others focused on “failures to update and provide complete prescribing information for a number of medicines.”
All three of these instances raised “very serious concerns around patient safety,” the ABPI said, adding that Astellas UK’s “failure to understand the scale of the problem was concerning.”
As for Astellas, it said Friday that "we deeply regret our failings, and in light of this we have reinforced our focus on patient safety. We are committed to providing the highest standards of care for everyone who relies on our medicines and services."
The Japan-based drugmaker first landed in hot water with the ABPI last June. After the company sent doctors on a junket to Milan to strategize about the U.K. launch of prostate cancer med Xtandi—and a host of complaints were filed with the Prescription Medicines Code of Practice Authority about Astellas Europe and Astellas UK. “Senior managers failed to provide full and accurate details” to the PMCPA panel and appeal board handling audits of the company, a memo said. “Very senior staff had lied and there was deception on a grand scale,” it concluded.
As the ABPI notes, Astellas this time around made commitments that dissuaded the ABPI board from kicking it out of the group completely. But it’s not in the clear yet: If re-audits, set for October of this year, don’t show “significant improvement and progress at both companies,” Astellas will once again be up for expulsion.
Meanwhile, the group suggests the two Astellas units consider bringing in outside help to assess its progress, “particularly in relation to the risk management of compliance in the broadest sense.”