Back in 1985, when Soon-Shiong was working as a surgeon, he was poised to perform a pioneering transplant of cells from pigs to humans when he made a chilling discovery.the FDA "can only inspect less than 1 percent of imported foods and drugs. For example, [the FDA] can go to virtually none of these foreign drug manufacturers because it simply does not have the staff to do so."
"We discovered a virus in pigs, and I refused to do that transplant," he said. "My investors said, You will do the transplants."
His investors later sued him for fraud, and he won in arbitration.
"I recall vividly, they said, 'You know, heroes and pioneers take risks, and all that you will suffer is a slap on the hand from the FDA.' And I said, 'No, that's not all I'll suffer. We'll put patients' lives at risk and I will not do it,'" he recalled.
"We don't have the resources to do that, nor should it be our primary responsibility," Woodcock said. She said the FDA keeps Americans safe "by holding the people accountable who are on the ground. Our inspectors can't be in every plant all the time."