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DeLauro Introduces Bill to Give FDA Mandatory Recall Authority over Drugs

February 16, 2017
Press Release

WASHINGTON, DC (February 16, 2017) Congresswoman Rosa DeLauro (CT-03) today introduced the Recall Unsafe Drugs Act, which would give the U.S. Food and Drug Administration mandatory recall authority over drugs and homeopathic products. DeLauro’s legislation follows the FDA’s recent findings that Hyland’s teething tablets contain elevated levels of the toxic substance, belladonna, which has been linked to more than 400 adverse event reports in children including death, seizures, shortness of breath, and tremors.

Despite the FDA issuing a number of safety warnings on the dangers of homeopathic teething products, Standard Homeopathic Co., the manufacturers of the Hyland’s teething tablets, has refused to recall its products. While the FDA does not have the authority to issue a mandatory recall for the product, leaving children at risk for injury or death, DeLauro’s legislation would resolve this issue.

“Hyland’s refusal to recall its teething tablets, despite numerous health and safety warnings from the FDA, is downright shameful. While the FDA has called on consumers to stop using the products, Hyland’s will not go above and beyond what the law requires and is choosing instead to prioritize the company’s profits and reputation before the safety of children,” said DeLauro. “There is absolutely no reason why a potential life-threatening product should be in our families’ homes where unsuspecting parents may give it to their children.”

“As it stands, the FDA would have to go through an arduous legal process to take action against manufacturers such as Hyland’s. This is unacceptable and threatens the health and safety of American families. The Recall Unsafe Drugs Act will enable the FDA to step in and issue a mandatory recall of drugs that have been found to cause serious health consequences or death,” continued DeLauro. “The lack of mandatory recall authority must be corrected and Congress should enact my legislation to take products off the market that are deemed a threat to consumers. The American people deserve to know that what they are using is safe.”

“The FDA currently lacks the authority to order recalls of drugs, leaving the agency with insufficient means to protect patients from potentially dangerous medications that have already been distributed to pharmacies, doctors and patients,” said Dr. Michael Carome, Director of Public Citizen’s Health Research Group. “Representative DeLauro’s bill will close this safety loophole and provide the FDA with an essential tool to better protect public health.”

Currently, the FDA has mandatory recall authority over other products that the agency regulates, such as medical devices, food, and biological products. Unfortunately, when something goes wrong with drugs, the FDA has to rely on the good faith of drug manufactures to recall their products. More often than not, drug manufacturers heed the warnings of the FDA when products are causing harm. However, there are times when manufacturers refuse to recall their products, even in the face of overwhelming evidence suggesting that they are causing illness or even death to consumers. DeLauro’s legislation would close this loophole and enable the FDA to step in and issue a mandatory recall.