The U.S. drug major now says that it had received a written approval from Nigerian authorities before administering Trovan- a drug that claimed the lives of 11 children in the northern Kano state in 1996.
"We have written approvals from NAFDAC (Nigeria's drug agency), the federal ministry of health, Kano government and parents or guardians of the children before the clinical test of the drug was carried out," said Ngozi Edozien, managing director of Pfizer Specialities Limited Nigeria, to a reporter.
Nigeria and Kano state government have filed two separate suits against Pfizer, claiming around some 9.5 billion dollars in damages for victims of the failed drug test. Pfizer is accused of carrying out improper trials for an anti-meningitis drug Trovan.
Pfizer denies any wrongdoing, claiming the trials were conducted according to Nigerian and international law but the government accuses the firm of carrying out the test without parental consent among children at a field hospital during an epidemic of meningitis, measles and cholera.
Apart from 11 deaths, nearly 181 children suffered from deafness, paralysis, brain damage and blindness. Trovan received an FDA approval for adult use in 1997 and the drug is now accepted as one of the most prescribed antibiotics in the U.S. market.
The federal government's suit is scheduled for a July 20 hearing while that of Kano government has been fixed for October 3.
