Justice Minister nominee Kim Seung-won again denied allegations of influence peddling over a new drug's clinical trial, saying that some media outlets claim the nominee engaged in "poison lobbying" but that this distorts the facts and misidentifies who is responsible. Kim said he had not known that Genencell omitted or manipulated animal testing data, and argued that the trial approval involved no preferential treatment.
Kim's confirmation hearing preparation team said in a statement on the 5th that after reviewing data showing therapeutic effects from overseas Phase 2 trials, it had simply relayed a grievance to the head of the Ministry of Food and Drug Safety so that clinical trial procedures for a domestically developed treatment would not be unfairly delayed. The team said the intent was not to demand approval of the treatment or unconditional clearance, but to ask for a fair judgment based on expert review.
In October 2021, Kim relayed a complaint about Genencell's clinical trial to Kim Ganglip, then commissioner of the Ministry of Food and Drug Safety, at the request of an acquaintance surnamed Yang. Two weeks later, the ministry approved the trial. The influence-peddling allegations surfaced after it emerged that Genencell had won trial approval with a false report that deliberately omitted side effects.
The preparation team said the nominee did not know that Kang, Genencell's chief executive, had omitted and manipulated some animal testing data in his submission, and that there was no confirmation of any involvement. It said a company official's independent criminal conduct was being maliciously and retroactively attributed to the nominee.
The team also rebutted a claim by Rep. Han Ji-a of the People Power Party that Genencell's trial was approved in 33 days, more than twice as fast as other Covid-19 treatments.
Citing ministry data on domestic clinical trial approvals for Covid-19 treatments from 2020 to 2022, Han said approvals of trial plans for treatments based on new chemical entities took an average of 71.6 days, while Genencell's was approved in 33 days.
The preparation team dismissed that figure, saying the 33 days was not the ministry's actual review time but simply elapsed days that included the period the company spent supplementing its data. That span included Sept. 30, 2021, when the ministry requested additional data, through Oct. 18 of that year, when Genencell submitted it.
According to official ministry data, the review of Genencell's application took 11 days, the team said, which was not faster than the average for new-substance trials but in fact longer. Comparing elapsed days that include supplementary periods varying by company, and then linking that to preferential treatment, uses a flawed standard, it said. The team added that the ministry's "GO Fast" program at the time had a target of 15 days or less, and that Genencell fell under it.
The team also said there was no evidence that Kim's contact changed the order or criteria of the review or led to any procedures being skipped, and criticized reports of lobbying for favors as ignoring the ministry's official calculation standards and its actual review process.
