DeLauro Celebrates FDA Mandatory Drug Recall Authority in the America COMPETES Act

WASHINGTON, D.C. — House Appropriations Committee Chair Rosa DeLauro (D-CT-03) today celebrated the inclusion of a provision in the America COMPETES Act to give the U.S. Food and Drug Administration (FDA) mandatory recall authority over drug products.

"For years, I have fought to advance legislation – the Recall Unsafe Drugs Act – giving the FDA mandatory recall authority over drugs so the Agency can fully use its regulatory authority to protect public health," said Congresswoman DeLauro. "I am pleased the America COMPETES Act includes this expanded authority; authority the Agency already has over foods, medical devices, and biological products. FDA's lack of mandatory drug recall authority has real-world consequences. Even if dangerous products that pose serious risks to consumers are discovered, the Agency can only request a recall. Companies can – and do – refuse voluntary recalls. That is unconscionable and puts people at risk. That is why I am committed to ensuring FDA receives this expanded authority and has the resources to mandate recalls of unsafe drugs."

"At Valisure, we applaud Congresswoman Rosa DeLauro for tirelessly advocating for the FDA to acquire mandatory recall authority over drugs and, ultimately, add this matter to the COMPETES Act," said Chief Executive Officer of Valisure David Light. "We strongly support efforts that can improve the quality of the U.S. drug supply, which is heavily reliant on a complex, global, and increasingly vulnerable supply chain. We hope the FDA will utilize its new authority in conjunction with the proven impact of independent testing, which has identified multiple adulterated products and industry-wide quality concerns. The combination of increased vigilance and independent quality assurance throughout the supply chain with enhanced regulatory authority has the potential to significantly diminish the unnecessary risk to consumers from contaminated or otherwise adulterated products. We encourage the FDA and Congress to continue taking actions in support of improving drug quality and the robustness of the global supply chain."

DeLauro first introduced legislation to give FDA mandatory recall authority over drugs in 2017 following the death of 10 children associated with Hyland's teething tablets. Overall, the teething tablets were linked to more than 400 adverse event reports in children including death, seizures, shortness of breath, and tremors. Despite the FDA issuing several safety warnings on the dangers of homeopathic teething products, the manufacturer refused to recall its products. That refusal left deadly products in the homes of unsuspecting parents who were still, unknowingly, giving it to their children.

Recently, DeLauro secured similar language to give FDA mandatory recall authority over drugs in the Fiscal Year 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies spending bill. That summer, a foreign manufacturer of hand sanitizers refused a voluntary recall request after the FDA discovered they were potentially contaminated with methanol, a toxic, life-threatening substance that can be absorbed through the skin or accidentally ingested by children.