FDA reverses debarment of one of its ex-chemists

A former US Food and Drug Administration (FDA) chemist who was banned from working on drug regulation for more than two decades for accepting bribes has been cleared. He was debarred for taking approximately $4300 (£2700) from senior officials at generic drug companies while he was allegedly involved in the regulation of their products.

The order against David Brancato, which has now been lifted, had meant that he could never provide services in any capacity to anyone with an approved or pending drug product application with the FDA.

Brancato, who pled guilty, had requested a pardon 17 years ago and was denied, but now the FDA says its change of heart came about because he has ‘provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA’s jurisdiction’. The agency has determined that ending Brancato’s debarment ‘serves the interest of justice and does not threaten the integrity of the drug approval process’.

The FDA says other factors that prompted its about-face include the fact that Brancato was convicted for a first offense, has had no prior or subsequent convictions for such conduct, has committed no other wrongful acts affecting the drug approval process and is highly regarded by his professional peers.

Despite the FDA’s action, Brancato says he will not be returning to the agency. ‘I am very happy that I persisted, better late than never,’ he tells Chemistry World. Brancato has been a toxicologist and a risk assessor at the Army Corps of Engineers since 1994.

‘I am happy that it brings a close to that period,’ Brancato says. He is nearing retirement age and has no plans become involved in drug reviews again.