The government’s recent announcement that it would nullify the license of Invossa-K was in breach of due procedures, Kolon Life Science said.
The Ministry of Food and Drug Safety said on Tuesday it would revoke Invossa approval. The ministry is to receive opinions from Kolon and make the final call by July 18.
Kolon Life Science disclosed on Wednesday that it received three notices from the ministry about its administrative measures. The three were prior notice for the nullification of Invossa license and procedures for opinion statements in accordance with the Article 31 of the Pharmaceutical Affairs Act, advanced notice for the cancelling of approval for phase-3 clinical trials of Invossa under the Article 34 of the Act, and advanced notice for the recall and disposal of Invossa under the Article 71.
Kolon emphasized that the ministry has yet to revoke Invossa license, opening a possibility for a reversal of the decision.
The ministry’s announcement of the plan to cancel the license did not mean an immediate nullification. If the company submits reasonable evidence at a hearing, the government could retract the decision and change the approval condition instead, Kolon said.
The hearing on the issue of Invossa license revocation is to be held on July 18.
Despite Kolon’s hope, there is a slim chance for the ministry to reverse its decision, observers said. It is improbable that Kolon could suddenly provide reasonable evidence at a hearing because it has failed to do so since the suspension of Invossa sales, they said.
However, Kolon is still clinging to the hope that the regulator’s possible breach of procedure for administrative punishment could twist the situation.
The abrupt announcement of the ministry’s plan of canceling the permit without prior notice to the company was a violation of the procedure, Kolon said.
Because the ministry announced the decision before collecting the company’s opinion, damages including the suspension of trading of Kolon Life Science shares were severe, Kolon argued. The company said it received the notice for a hearing in late Tuesday after the ministry announced in the morning.
The food and drug ministry said it did not have any problem in the procedure and Kolon is expected to fight back at the court.