Lagos, Nigeria-FDA refused to confirm or deny that it was launching a criminal investigation into Pfizer’s conduct during a 1996 clinical trial for Trovan (alatrofloxacin) in Nigerian patients.

FDA’s "no comment" follows the Washington Post’s report that its Office of Criminal Investigation has been collecting information about the trial of the antibiotic, which has since been approved.

In August, a lawsuit filed in a New York district court on behalf of 30 children alleged that the trial was conducted during an epidemic of bacterial meningitis in Nigeria. It asserts that Pfizer chose to embark on a trial when it knew there were problems with the medicine and that the company failed to secure patients’ consent. The result was brain damage and sometimes death, say the plaintiffs, including the families of 7 of the 11 children who died.

The lawsuit charges Pfizer with selecting children to participate in a medical experiment of a "new, untested, and unproven drug without first obtaining their informed consent" rather than providing the children with a safe, effective, and proven therapy for bacterial meningitis.

FDA’s silence on the matter is said to be standard practice. Pfizer defended Trovan’s safety, saying the company was "proud" of the way it conducted this "important clinical investigation."

Pfizer says the study was well conceived, well executed, and conducted with the approval of the Nigerian federal and state governments and with consent from patients’ families. In addition to saving lives, it says results showed that Trovan was as effective as ceftriaxone, another antibiotic treatment.