DeLauro Reiterates Call to Ban Ranitidine Sales, Reintroduces Bill to Giving FDA Mandatory Recall Authority Over Drugs
WASHINGTON, DC — (January 10, 2020) At a news conference today in the Capitol with medical experts, Congresswoman Rosa DeLauro (CT-03) reiterated her call to ban sales of ranitidine—the active ingredient in Zantac—and reintroduced the Recall Unsafe Drugs Act. Her legislation would give the United States Food and Drug Administration (FDA) mandatory recall authority over drugs and homeopathic products.
Joining her at today’s news conference were:
- David Light, Founder & CEO of Valisure;
- Joe Graedon, Pharmacologist and Co-Host of The People’s Pharmacy on NPR; and
- Dr. Jon Ernstoff, Gastroenterologist at MidState Medical Center in Connecticut
“The FDA’s mission is to protect public health by assuring drugs, medical devices, and our nation’s food supply are safe. Yet, every day, drugs and homeopathic products with significant evidence of safety concerns remain available to consumers across the country. That is unacceptable,” said Congresswoman DeLauro. “The Recall Unsafe Drugs Act would enable the FDA to step in and issue a mandatory recall of products that have been found to cause serious health consequences or death. As Valisure and its research partners have found in their research, this problem extends to popular drugs like Zantac. People deserve to know that the medication they are using is safe. As a regulatory agency, the FDA needs to thoroughly review the safety of drugs before they come to market and while they are on the market. Anything short of that is a failure that puts lives at risk.”
Late last year, DeLauro wrote a letter to (FDA) Commissioner Stephen Hahn and the Department of Health and Human Services (HHS) Secretary Alex Azar to recall drugs containing ranitidine due to high levels of N-Nitrososdimethylamine (“NDMA”), a probable human carcinogen. A signed copy of the letter can be found here.
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.