FDA needs help

FDA needs help

Washington Post: Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, had reassuring news for the American people at a Senate hearing on Thursday: “We are confident the (blood-thinning drug) heparin in the United States is safe.” She highlighted a report from the New England Journal of Medicine, released earlier that day, which established a possible link between the contaminant found in tainted batches of heparin imported from China and adverse side effects. In the United States, 81 people died. About 80 allergic cases were reported in Germany.

But Woodcock’s reassurance was tempered by her warning to the Senate Health, Education, Labor and Pensions Committee that the FDA is an underfunded, 20th-century domestic agency struggling to protect American consumers in a globalized, 21st-century world. Some applications to import generic drugs may cite 15 different facilities anywhere in the world for one particular drug. The heparin case shows how the complexity can put lives at risk.

Tough trail to follow

The tainted drug was sold by Baxter International. The active ingredients were processed by one of Baxter’s Chinese suppliers, Changzhou SPL, which bought the heparin from two other companies that harvested the raw ingredients from pig intestines. At what point the contaminant made its way into the supply chain remains unknown. Chinese drug authorities didn’t poke around the Changzhou plant because they listed it as a chemical plant. The FDA says it never inspected the facility because of a clerical error. But the agency also notes that even if it had, it never would have found the heparin contaminant because it appeared chemically identical to genuine heparin in initial testing.

Woodcock described what the agency needs to better safeguard the nation’s pharmaceutical supply: more inspectors, modern information technology systems and enhanced science. The FDA is set to open three offices staffed with 13 inspectors in China by the end of the year. But Woodcock demurred when senators pleaded with her to say how much funding the FDA would need for this task. The administration has underfunded the FDA, as it has so many regulatory agencies; responsible officials need to put a price tag on what they need to get the job done.