The Medicine Control Council has denied that its decision to review nevirapine was a political one, saying it would not allow itself to be treated as ”banana regulatory authority”.
The council was responding to accusations that its rejection of a Ugandan study on nevirapine, which is used to prevent mother-to-child transmission of HIV, was motivated by the government’s reluctance to institute a national Aids plan.
The council has given pharmaceutical giant Boehringer-Ingelheim, the manufacturer of nevirapine, 90 days to provide new data on the safety and efficacy of the drug.
The drug will be deregistered if new data are not submitted to the council within the deadline. If the drug is deregistered, the government will be forced to find alternative anti-retroviral drugs in terms of a Constitutional Court ruling last year.
Precious Matsoso, the council’s registrar, this week said the government was not behind the decision to reject the findings of the Ugandan study submitted by Boehringer-Ingelheim.
Matsoso said the study did not meet the council’s standards. ”It would be irresponsible of us to make this a political issue. A letter was written by Boehringer to alert us to the problems in the Uganda trial. How can this be a political issue if they wrote to us?
”We are not a banana regulatory authority, to forget it [evidence] because of an emotive issue.”
The pressure is now on Boehringer to provide an alternative study. ”I have heard that there is sufficient evidence and it is not difficult for them to find and submit it [before the deadline],” Motsoso said.
Read Don’t crow too soon over nevirapine.