The FDA Caves In to Industry on Tardive Dyskinesia

Approximately 5 months after the meeting, in the summer of 1984, Leber sent a formal letter to all neuroleptic manufacturers, suggesting a revision of the proposed class warning label. By then, almost surely in response to industry pressure, the proposed language had already been watered down. Without mentioning any figures, Leber s proposed label stated that TD would develop in a substantial portion of patients treated with neuroleptics (P. Leber, unpublished letter, 1984, p. 3). The meaning of substantial was left up to interpretation. 

The FDA s Pharmacologic Drugs Advisory Committee met a second time on January 31, 1985, to discuss TD. Leber again mentioned the impact of the clamor from the press in the fall of 1983—the date of Dan Rather s TV report and the simultaneous publication of my book. 

Leber told the assembled representatives of the drug companies that he would not act without their endorsement or approval. He stated that he had been through a year and a half of trying to bring about change in the labeling of neuroleptic products that would be fair and that would be acceptable to everyone (FDA, 1985b, emphasis added). 

Leber described to the meeting participants the elaborate back and forth negotiating that had already gone on between the FDA and industry. He said that one of his aims was to obtain equitable labeling that did not cause injury to industry, as much as it also should not cause injury to patients or physicians who have to use neuroleptics under trying circumstances (FDA, 1985b, p. 9, emphasis added). 

By this second meeting, Leber and the FDA had surrendered to industry. The somewhat ominous phrase substantial proportion was replaced by the entirely innocuous phrase some patients, implying a minimal risk. Ironically, it was the same phrase that appeared on the outdated 1973 label. No change had been made. 

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