DeLauro Statement on Faulty Tests for Lead Poisoning in Children
WASHINGTON, DC (May 17, 2017) — Congresswoman Rosa DeLauro (CT-03) today released the following statement regarding news that a laboratory test for lead poisoning from Magellan Diagnostics approved by the U.S. Food and Drug Administration (FDA) has been found to be inaccurate.
“Millions of American families test their children for lead exposure and poisoning every year, hoping to ensure that children are treated for this life-altering and devastating complication. When the health of our children is at risk, families should be able to depend on these tests to ensure that their children can be properly diagnosed and treated. As a result of approving this defective test through the less stringent 510(k) pathway, the FDA has failed to do its job as a regulatory agency and it has given a false sense of security to families that have been greatly impacted by water quality and lead tragedies.
“With more than 8 million tests given from this company over the last three years, children exposed to and poisoned by lead may have gone without treatment, potentially leaving them with lifelong health consequences. From diminished academic abilities, to behavioral issues, the effects of lead poisoning are severe and are best treated with early detection. Unfortunately, the FDA’s negligent approval process has jeopardized the health of American children. The FDA must do everything within its power to determine how these faulty tests were allowed to be on the market, and work to remedy the situation immediately.”