More than 20 years after the U.S. Food and Drug Administration permanently debarred a former chemist for accepting bribes — and a puzzling 17 years after he asked for a pardon after helping the agency prosecute other cases — the FDA is lifting its debarment.

In 1994, chemist David J. Brancato:

…was permanently debarred from providing services in any capacity to a person with an approved or pending drug product application…

This suggests that he wasn’t even able to work with anyone with an FDA-approved product.

The reason the debarment was lifted?

FDA bases this order on a finding that Dr. Brancato provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA’s jurisdiction, and that special termination of Dr. Brancato’s debarment serves the interest of justice and does not threaten the integrity of the drug approval process.

According to an FDA spokesperson, the lifting of the debarment means Brancato “can return to work for industry.”

Brancato was sentenced in 1990, after pleading guilty to accepting $4,300 from officials at Par Pharmaceutical, Inc. (Par), and its subsidiary, Quad Pharmaceuticals, Inc. (Quad). At the time, according to the FDA, Brancato:

was involved in the regulation of Par’s and Quad’s drug products and while he was specifically responsible for reviewing Par’s and Quad’s applications to determine whether those applications met certain statutory standards for approval.

But Brancato apparently fought his sentence:

In a letter dated December 21, 1992, Mr. Brancato requested a hearing and submitted arguments and information in support of his hearing request. In his request for a hearing, Mr. Brancato acknowledges that he was convicted of a felony under Federal law as alleged by FDA; however, he argues that FDA’s findings are incorrect and that the agency’s proposal to debar him is unconstitutional.

It appears that Brancato argued, among other things, that his offense occurred before the establishment of the act that would debar him, which he believed shouldn’t be applied retroactively. He also argued that his “conduct” should be considered “subject to permissive debarment…rather than to mandatory debarment.”

Finally, Brancato argued that such a sanction should not apply to “individuals who cooperate with the government.” To this, the FDA replied:

Cooperation with the government may not be considered in the decision to initiate mandatory debarment proceedings. (Cooperation may, however, be considered in determining whether to grant special early termination of debarment, under section 306(d)(4)(C) of the act, to individuals and as evidence of mitigation, in determining appropriateness and period of permissive debarment.) Because Mr. Brancato’s cooperation is immaterial here, his claim fails to raise a genuine and substantial issue of fact.

In 1994, the FDA found Brancato’s arguments “unpersuasive,” and insufficient to warrant a hearing. Four years later, Brancato applied for special termination of the debarment, per the FDA’s stipulations. He didn’t hear anything for nearly 17 years. (We’ve asked the FDA to explain what took so long in this case.)

On April 15, 2015, the FDA “requested additional information.” Five days later, Brancato supplied it.

Three months later, effective today, Brancato earned a special termination of his debarment:

Dr. Brancato cooperated with the United States Attorney’s Office in the investigation of several individuals, as substantiated by letters submitted to the Agency by Thomas Holland, a Special Agent in the Office of the Inspector General, U.S. Department of Health and Human Services, and the U.S. Attorney’s Office for the District of Columbia. His cooperation contributed to the successful prosecution of these individuals, and in one instance continued over a period of 7 years. Accordingly, FDA finds that Dr. Brancato provided substantial assistance as required by section 306(d)(4)(C) of the FD&C Act…. The evidence presented to FDA in support of termination shows that Dr. Brancato was convicted for a first offense; that he has no prior or subsequent convictions for conduct described under the FD&C Act and has committed no other wrongful acts affecting the drug approval process; and that his character and scientific accomplishments are highly regarded by his professional peers. The evidence presented supports the conclusion that the conduct upon which Dr. Brancato’s debarment was based is unlikely to recur. For these reasons, the Agency finds that termination of Dr. Brancato’s debarment serves the interest of justice and will not pose a threat to the integrity of the drug approval process.

Clearly, Brancato has an interesting story to tell. We’ve been trying to track him down to hear it, to no avail (so far).

Hat tip: Theresa Defino

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