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Will parliamentary audit uncover why Invossa was mislabeled?
  • By Jeong Sae-im
  • Published 2019.10.01 15:45
  • Updated 2019.10.01 15:45
  • comments 0

The National Assembly’s Health and Welfare Committee is expected to focus on two key issues – mislabeled gene therapy Invossa-K and Allergan’s recalled breast implant – in the 20th parliamentary audit for the pharmaceutical and biopharmaceutical sector starting from Wednesday.

People related to the suspension of Invossa took up the largest share of the general witnesses that the committee decided to summon for the audit. Six of the 18 general witnesses will testify on the Invossa issue.

Among the general witnesses are Kolon Life Science CEO Lee Woo-sok, Managing Director Kim Soo-jung, and Kolon TissueGene CEO Noh Moon-jong.

The health and welfare committee will ask Lee whether he was aware of the mislabeling of the second fluid of Invossa during drug development and approval procedure, whether he unfairly intervened in drug development or ordered a cell ingredient mix-up, whether he took enough follow-up measures for Invossa-treated patients and investors, and how the company was proceeding the legal action against the Ministry of Food and Drug Safety.

Lawmakers will also ask Kim, who received a presidential citation for Invossa research, whether she was aware of the mislabeling of the cell ingredient during R&D for the treatment and whether she ordered workers to mislabel it intentionally.

Noh has been called to testify as well. He is one of the developers of Invossa. Noh was the head of the life science research team at Kolon’s central research institute, leading the early development of Invossa jointly with Inha University professor Lee Kwan-hee.

Noh is the key person as the only early developer who is still working for Kolon. He is known to understand best how Invossa’s second fluid contained GP2-293 cells, not cartilage-derived cells. Noh was appointed as CEO of Kolon TissueGene on March 27, just before Kolon found the labeling error.

During the audit, lawmakers plan to check if he had known 293 cells had been mixed in the second fluid when the company was developing the treatment. However, it is unclear Noh will attend the audit because he lives in the U.S.

Also included in the witnesses is Eom Tae-seob, a lawyer at Oh Kims, who is helping Invossa-treated patients file a lawsuit against Kolon.

Eom conducted an epidemiological study for Invossa-treated patients, jointly with the Association of Physicians for Humanism (APH), in September. Based on the study, lawmakers will check the status of victims and the problems of follow-up measures.

Lawmakers will also ask Viaplus CEO Lee Min-young and Choo Hyun-seun, the head of Sungkyunkwan University’s Industrial-Academic Cooperation Team, who wrote the economic feasibility report regarding Invossa reimbursement, to see if they received an unfair order or interventions from Kolon during their studies.

Professor Baek Han-joo at the Rheumatism Department of Gachon University Gil Medical Center is on the reference list for the Invossa issue.

The parliamentary audit will also deal with Allergan’s recall of breast implant, as the health authorities recently received the first report of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in a local patient who had Allergan’s specific type of textured implant.

Lawmakers decided to summon Allergan Korea CEO Kim Ji-hyun to ask what her stance was on the product’s harm, whether the company took safety measures and warnings fully for patients, and whether the compensation plan was sufficient.

The compensations will differ depending on the types of patients. Patients diagnosed with BIA-ALCL will benefit from the national health insurance, and Allergan will support up to $7,500 (about 9 million won) for the patient’s contribution or non-reimbursable treatment.

If a patient has suspected BIA-ALCL symptoms and needs a diagnosis, Allergan will provide up to $1,000 support for pathology and ultrasound tests per session. Patients without suspected BIA-ALCL symptoms who want to replace the breast implant can receive Allergan’s smooth surface breast implant for free.

However, recipients of Allergan’s breast implant claimed that the compensation plan was disappointing because the full compensation was only for patients with BIA-ALCL.

same@docdocdoc.co.kr

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