Tbilisi Mayor Kakha Kaladze has stated that the manufacturer of the Duchenne treatment drug, which parents of children with the condition are requesting be brought into Georgia, cannot itself take responsibility for the medicine’s efficacy and safety.

He made these remarks in connection with a conclusion published by the United States Food and Drug Administration, pursuant to which the medication has been assigned a so-called black box warning.

“I shall be frank with you, I am no specialist in this field, but given how acute the issue had become, I too looked into what the situation was regarding this matter. Anyone can verify that the company manufacturing this drug cannot itself take responsibility for it. Setting aside all political considerations, I ask a very simple, human question: do you believe it is right for the state to take a decision and purchase a medicine for these families and these children for which the manufacturer itself cannot take responsibility?” declared Kakha Kaladze.