A quarter of drugs, which have received fast-track marketing licenses for the reason of urgent supply since 2010, showed no records of production or imports at all, a lawmaker said Tuesday.
In a parliamentary audit of the Ministry of Food and Drug Safety, Rep. Kim Sang-hoon of the opposition Liberty Party Korea said 12 drugs out of the total 48, which received approvals on condition of phase-3 clinical trials between 2010 and 2016, showed zero production or imports.
The ministry gives phase-3 conditional approval to new medicines, which can treat patients who suffer from diseases that cannot be cured with the existing medications. The sales approval is granted on the condition that the drug maker submits the result of the phase-3 clinical trial to the health authorities after the launch of the drug.
The 12 drugs without any records of supply to the Korean market include Roche Korea’s Tecentriq (ingredient: atezolizumab), Cotellic (ingredient: cobimetinib), Alecensa (ingredient: alectinib), Eli Lilly Korea’s Latruvo (ingredient: olaratumab), Celgene’s Istodax (ingredient: romidepsin), Novartis Korea’s Mekinist (ingredient: trametinib dimethyl sulfoxide), Gilead’s Zydelig (ingredient: idelalisib), and Meditip’s Translarna Granule (ingredient: ataluren).
Among them, Celgene’s Istodax has not had any import for the longest time since getting the fast-track approval in 2013. Gilead voluntarily canceled the endorsement on its Zydelig in the following year of getting the conditional sales license.
“If pharmaceutical companies do not supply the drugs for patients after enjoying the privilege of fast-track approvals, the conditional approval system will lose its purpose,” Kim said.
Before approving, the ministry should thoroughly study the demand for the drug, the manufacturer’s supply plan after the drug launch, and check the manufacturer meets additional conditions after the drug sales. Those without any production should be under a strict review, he added.
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