Drug Ministry accused of mishandling InvossaThe Ministry of Food and Drug Safety has been criticized for its lack of effort in controlling the aftermath of the Invossa scandal.
The regulator is also under fire for making suspicious personnel moves and seemingly hurrying through the process of granting approval for the drug.
During the annual audit of the ministry on Monday, lawmakers grilled the regulator for doing little to respond to more than 300 side effects including tumor abnormalities reported from patients who were injected with Kolon Life Science’s controversial gene therapy drug.
According to data Rep. Jung Choun-sook of the Democratic Party received from the ministry, as of Sept. 27, the local regulator had only registered 2,408 patients, or 76 percent, of a total of 3,701 patients who were injected with Invossa, including those who received the treatment during the gene therapy’s clinical trials in the country.
The remaining 762 patients, or 24 percent, had still received no follow-up measures from the ministry. The Drug Safety Ministry had announced in June, around two months after the Invossa scandal erupted, that it would work with Kolon Life Science to track the health of Invossa?injected patients for the next 15 years.
The ministry planned to complete initial check-ups by December and start analyzing the results. But as the regulator has yet to make contact with so many patients, the timeline is in danger of being pushed back. The longer patients have to wait for check-ups, the greater the chance that serious side effects could develop unchecked.
Invossa, which was stripped of its license in July this year, was found in April to contain a different cell line from what was approved for sale in Korea and for clinical trials in the United States. The gene therapy drug was granted approval for commercialization in July 2017 on the basis that it used cartilage-originated basis cells, not kidney cells.
The presence of kidney cells is a potential health hazard, as the errant cells could cause tumors. According to data Jung received from the Korean drug authority last week, there were a total of eight tumor-related abnormality cases among Invossa-injected patients out of a total of 329 reported cases of side effects.
The Ministry of Food and Drug Safety was also criticized during the audit for apparently hurrying to grant approval for Invossa.
According to the recorded ministry timeline, Invossa received final approval on July 12, 2017, the last day that former Food and Drug Safety Minister Sohn Mun-gi was in office and the day before former Minister Ryu Young-jin took office.
The data shows that lower-level approval was made just 27 minutes prior to the end of business hours at 5:33 p.m. on July 11, and a senior-level official started reviewing the case a little less than an hour later at 6:23 p.m. that day.
The same official immediately approved it upon entering the office the next day at 8:24 a.m. and final approval was made within the ministry just 16 minutes later at 8:40 a.m. on July 12, 2017.
The drug authority has already been under fire for making suspicious personnel moves in granting expert approval for Invossa. The move was again called into question by a number of lawmakers during the Monday audit.
During an initial hearing held in April 2017, most of the experts rejected the drug from being commercialized due to its hefty price tag and lack of clinical proof that it actually regenerates joints. Only one committee member was in favor of the commercialization of Invossa.
In a hearing held two months later, the ministry brought in five new pro-Invossa experts while excluding three anti-Invossa experts. The drug received the approval of six of nine experts.
BY KO JUN-TAE [email@example.com]