'Pharmaceutical Companies Must Take Responsibility'

"It became very clear to me that, unfortunately, the future is that China and India will be the breadbasket of raw materials, creating the raw materials for the rest of the world," he said. "I think heparin is a prime example of where pharmaceutical companies must take responsibility"

He said the FDA must also take responsibility, "but the FDA is overwhelmed," he said.   Heparin may be used in high-tech medicine, but the raw material is literally hand-wrung from pigs' intestines in crude agricultural workshops. And the process is virtually unregulated.

"There is no process controls at the farmer level," Soon-Shiong said. "One has no idea what crude comes in, the source of the crude, are the pigs ill, do these pigs have any viruses. Frankly, are these pigs, even?"

Soon-Shiong says at his plant in China they track the entire supply chain, from "the live pig, the health and welfare of the pig, all the way to the slaughterhouse, all the way to the intestine, all the way into the crude heparin, all the way into the final heparin."

Prioritizing Patients

It's not the first time he has bucked his own industry. 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.

"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.

Soon-Shiong's unwavering stance in the face of opposition may come from his personal biography. He grew up in South Africa under apartheid, and he had to fight to become the first nonwhite doctor in a whites-only hospital.

He later emigrated to the U.S. with his wife Michele, whose career as a television actress paid the bills while he labored in a university lab.

"I wanted to follow my dreams with regard to my science and my research," he said. 

The gamble paid off. Soon-Shiong's medical prowess and business skills have made him one of the richest men in the pharmaceutical industry.

Self-Regulation

FDA Commissioner Janet Woodcock says the FDA is taking a "much closer look" at the safety of drugs that come from overseas, but the administration is woefully underfunded to safeguard America's drug supply.

Hubbard said 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 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."

In fact, the FDA never even inspected Baxter's supplier "SPL" in China because they couldn't find it.

"The plant wasn't inspected because there was a mix-up between that plant and another one," Woodcock said, "and it appeared that the plant that had been mixed up with this plant actually had been inspected, and so we felt that this plant had been inspected."

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