The Biden administration has outsourced production of cancer drugs to a Chinese pharmaceutical giant that was once investigated for using a toxic sludge called gutter oil to make antibiotics.
The Food and Drug Administration announced last week it will purchase the chemotherapy drug cisplatin from China's Qilu Pharmaceutical in a bid to alleviate what one expert called "one of the worst chemotherapy drug shortages in history." Chinese authorities investigated Qilu, one of the country's largest drugmakers, in 2012 for using discarded cooking oil from restaurants to make antibiotics. The FDA has not approved cisplatin for use in the United States but has granted a temporary waiver to combat a chemotherapy supply chain crisis that has caused widespread delays in treatment for lung, cervical, and other cancers.
The supply chain snafu threatens to derail President Joe Biden's pledge to "end cancer as we know it." Congress has appropriated $1.8 billion since then-vice president Biden launched his "Cancer Moonshot" in 2016. The president in 2022 "reignited" the moonshot and this March asked Congress for an additional $2.8 billion in funding. Researchers say a cure for cancer is still far off.
American lawmakers and medical experts have long called for the FDA to investigate foreign suppliers of raw materials for drugs. Investigative journalist Katherine Eban told the U.S.-China Economic and Security Review Commission in 2019 that China remains "a continuing source of adulterated drug products" and that the FDA has "found widespread fraud and manipulation of quality data in Chinese manufacturing plants." Sen. Chuck Grassley (R., Iowa) in 2019 called on the FDA to ramp up its inspections of overseas drug manufacturers that produce materials for American pharmaceuticals. Grassley noted that 80 percent of raw materials used in American drugs come from China and India.
Gutter oil, which is considered highly toxic and contains carcinogens, has been widely used in China's restaurants and food manufacturers for decades as an alternative to more expensive cooking oils. Qilu accepted responsibility for using gutter oil in its drugs but claimed it was unaware of the ingredients used by its suppliers.
The gutter oil scandal was part of a broader pattern of Chinese drugmakers using "cut-rate practices" to manufacture drugs, drug industry trade publication Fierce Pharma said at the time.
Chinese drugmakers have been at the center of several high-profile tainting scandals. Eighty-one Americans died in 2008 after taking the heart drug heparin, which was supplied by a Chinese company that used contaminated raw materials derived from pigs. And in 2018, the FDA recalled the Chinese-made valsartan, a blood pressure drug found to contain carcinogenic materials.
The FDA and Qilu did not respond to requests for comment. But FDA chief Robert Califf said last week, after the Qilu partnership was announced, that the agency will "very carefully assess product quality" and require its partners to "ensure the products are safe for patients."
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