DeLauro Secures Critical Protections from Dangerous Products Marketed During the COVID-19 Pandemic
After DeLauro’s Two Decades of Work on this Issue, House Appropriations Committee Passes DeLauro-led Provision Giving FDA Authority to Issue Mandatory Recall of Dangerous Hand Sanitizer
WASHINGTON, D.C. — Congresswoman Rosa DeLauro (CT-03), Chair of the Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee, and the House Appropriations Committee, today approved by voice vote an amendment offered by Subcommittee Chairman Sanford D. Bishop, Jr. (GA-02) to the Fiscal Year (FY) 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies spending bill that would protect Americans from dangerous products being marketed during the COVID-19 pandemic.
DeLauro has long advocated for expanding FDA’s mandatory recall authority to include drug products; an authority the Agency already has over other products it regulates, such as medical devices, foods, and biological products. The amendment that passed today is similar to DeLauro’s Recall Unsafe Drugs Act, legislation first introduced in 2017 and reintroduced in January 2020, that would close the existing loophole in FDA’s regulatory authority and enable the Agency to step in and issue a mandatory recall.
“As people work to protect themselves and their families during the COVID-19 pandemic, it is troubling that FDA lacks the ability to mandate recalls of dangerous products, like contaminated hand sanitizers,” said Congresswoman DeLauro. “Three weeks have now passed since a foreign manufacturer refused to issue a voluntary recall at FDA’s request. That is unconscionable, puts people’s lives in jeopardy, and is an outcome I have feared for the past two decades as I’ve worked to change this policy. As this pandemic continues, it is likely FDA will uncover more dangerous products that pose risks to consumers. That is why I am committed to ensuring FDA receives this expanded authority and has the resources to protect public health.”
Last month, U.S. Food and Drug Administration (FDA) advised consumers not to use more than ten brands of imported hand sanitizer due to the presence of methanol, a toxic substance than can be absorbed through the skin or accidentally ingested by children. According to the FDA, such “methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.”
On June 17, 2020, FDA asked the foreign manufacturer of these products, Eskbiochem SA de CV, to issue a voluntary recall. According to FDA, the manufacturer refused this request and has failed to remove these potentially life-threatening products from the market. Without mandatory recall authority, the Agency’s efforts to protect Americans have been significantly hampered.
“The FDA’s mission is to protect public health by assuring drugs, medical devices, and our nation’s food supply are safe,” said Congresswoman DeLauro. “I’m proud the House Appropriations Committee is taking this issue seriously as the coronavirus pandemic continues to surge across the country, and I look forward to this amendment’s inclusion in the final FY21 agriculture spending bill.”
The FY 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies spending bill next heads to the House Floor to be considered for passage.