USA – FDA has little authority to control quality of foreign-made APIs

Following major recalls of Chinese-manufactured medication that contained carcinogenic ingredients, Congress is taking a hard look at the U.S. supply chain of generic drugs.

About 80 percent of manufacturers that create key ingredients for the domestic drug market are located outside the United States, according to the U.S. Food and Drug Administration (FDA). But for some drugs, China is the only supplier.

At a congressional hearing on Tuesday, lawmakers expressed alarm, and sometimes disbelief, at the lack of oversight the FDA demonstrates over these foreign suppliers—despite the fact that U.S. drug firms are continuously outsourcing their manufacturing needs.

« There’s a hidden health crisis in this country that will affect us all, » Rep. Anna Eshoo of California, chair of the Health Subcommittee, said in the hearing. « The crippling inadequacy of the American drug supply. »

Eshoo went on to say that the U.S. generic-drug industry’s reliance on foreign agents creates shortages of life-saving medications as well as subpar manufacturing.

Indeed, in the past two years alone, the FDA has recalled three blood pressure drugs and the heartburn medication Zantac after they were found to contain potentially carcinogenic impurities that their Chinese manufacturer failed to report.

To the surprise of lawmakers in the room, regulators at the hearing said they cannot control or properly monitor these dangerous drugs until long after they’ve reached U.S. shores.

Active pharmaceutical ingredients (APIs) are the backbone of the generics industry. They make up the part of the drug that generics are supposed to share with their brand-name counterparts…