Questionable FDA Practices Regarding Ketek

There are two allegations regarding the circumstances about how the FDA approved Ketek for the marketplace: Questions arose about how the FDA’s management instructed FDA officials to present fraudulent data to the Advisory Committee because discussing issues regarding data integrity and the conduct of a safety study would not be productive; and, did the FDA actually presenting fraudulent study data to the Advisory Committee? About two months prior to the 2003 Advisory Committee meeting, the study site with the largest number of enrolled subjects (407) was under investigation by FDA’s Office of Criminal Investigations. The FDA also inspected the second and third highest enrolling sites and found them to have similarly violated the protocol. In addition, 72 other sites raised red flags for FDA officials and investigators, including non adherence to the study protocol, which recommended between 4 and 50 study subjects per site. FDA officials also questioned how quickly more than 24,000 patients were enrolled in the study. The FDA official charged with presenting at the Advisory Committee stated that he was not satisfied with what he knew about the integrity of a study and was against presenting it. When asked why he did indeed present a study he knew to have data integrity problems, the official replied that he was asked directly by the FDA Division Director. The Advisory Committee members said they were not aware of the data integrity problems until July 7, 2006. Several Advisory Committee members also responded that knowledge of the data integrity problems might have affected their vote. Ketek received a seal of approval amidst and botched and questionable study of participants who never existed.