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Delaney then asked a group of doctors to design a protocol, or test model, based on an FDA trial for a similar drug called Ricin Toxin. Delaney says several FDA and National Institutes of Health officials in Washington were told of Project Inform's proposed trial, which was planned for patients in San Francisco, Los Angeles and New York City. "At no time did anyone tell us to stop," he says. An FDA spokesman in Washington claims officials did not hear about the clandestine trials until well after they began...
Without revealing the purpose, Project Inform asked Genelabs, Inc., a California biotechnology firm that manufactures the drug in the U.S., to test samples of Compound Q that Corti brought back from China. They wanted to make sure it was identical to the Compound Q used in the FDA-approved study. An attorney drew up guidelines that would keep the trials within federal law. Each patient made a videotaped statement, in the presence of an attorney and a witness, that he was entering the trial of his own free will. "What we wanted was a trial that was faster than...
...current scandal started to unravel after Roy McKnight, head of Pittsburgh-based Mylan Laboratories, began to suspect the FDA of favoritism. Frustrated that a rival firm consistently won FDA approval for its products before his company did, McKnight hired private detectives to spy on the Government. The detectives' snooping produced enough evidence of corruption to encourage the Justice Department to initiate a probe. In July, Charles Chang, 47, former head of the FDA's generic-drug division, and two co-workers pleaded guilty to accepting a total of $24,300 in illegal gifts in exchange for preferential treatment. The favored...
...FDA pursued its own probe, it discovered that Vitarine Pharmaceuticals of New York City had taken a more drastic step to ensure approval of its generic version of Dyazide, a standard antihypertension drug developed by SmithKline. The generic-drug company substituted Dyazide for its own capsules and sailed right through the efficacy tests. Vitarine admitted the deception earlier this month and has recalled the product...
CREDIT: [TMFONT 1 d #666666 d {Source: FDA}]CAPTION: FDA Inspections