In 1996, Baldev Raj Bhutani pled guilty to one count of conspiracy and six count of violation the federal Food, Drug and Cosmetic Act for his role in manufacturing adulterated pharmaceuticals in violation of US regulations on good manufacturing processes, as well for manufacturing opioid painkillers without following proper record-keeping requirements and for using decomposed raw material; in finished products. In 2004 the FDA permanently barred Bhutani from providing services to any company with an approval pending before the FDA.
Now 9 years later, the FDA has refused his most recent request to overturn his debarment. The FDA claimed that since Bhutani’s debarment was based on his convictions, two of which were felonies, he could only be reinstated if the convictions were overturned or if he had provided substantial assistance to the investigation that led to his conviction. In determining that Bhutani was not eligible, the agency found that he had offered no substantial assistance precisely because Bhutani made no showing that the Department of Justice, which had prosecuted him, considered him to be cooperative, or that the DOJ agency had moved to reduce the severity of his punishment. The FDA further found that Bhutani has offered no substantial assistance to the government. The agency noted that he merely agreed to comply with the law after he had already violated it.