Congressman Kim Reintroduces Mandatory FDA Recall Bill to Protect Consumers from Unsafe Prescription and Over-the-Counter Medicines

WASHINGTON D.C. – Today, Congressman Andy Kim (NJ-03) reintroduced his Protecting Americans from Unsafe Drugs Act which would provide the Food and Drug Administration (FDA) with mandatory recall authority for any and all faulty or unsafe prescription and over-the-counter drugs.

“This bill is an important part of keeping Americans safe from defective medicines. By providing the FDA with the tools they need, we can prevent widespread usage of a product that would end up doing harm instead of the good it was intended to do,” said Congressman Kim. “If this bill becomes law, it would hold companies accountable, ensuring that local pharmacies and businesses are not on the hook after being sold and delivered sub-par medicines. It would also prevent those small businesses and pharmacies from having to pay to store those medicines in their own storage facilities in order to keep them out of the hands of Americans. I urge my colleagues in both parties in the House and Senate to pass this bill and protect Americans.”

This bill would give FDA mandatory recall authority for all drugs – including hand sanitizer – when they could cause serious adverse health consequences or death. Legislation to provide mandatory recall authority for prescription and over-the-counter drugs has been introduced and passed in the House multiple times in the past. A similar provision was adopted by the House of Representatives on a bipartisan basis in 2018 and was later included by the House Appropriations Committee in a bipartisan FY2021 proposal. The bill passed the House part of the House Passed America COMPETES Act, but it was not included in the CHIPS and Science Act. Now, Congressman Kim’s bill also concurs with the FDA mandatory recall authority proposal included within the Biden Administration’s FY2024 budget announced this past March.

Currently, FDA does not have mandatory recall authority even though they have had this long-standing authority for food products since 2011, and were just recently afforded this authority for cosmetic products in the 2023 omnibus bill. This issue was brought to Congressman Kim’s attention by a former constituent and small business owner whose business was saddled with $5 million in contaminated hand sanitizer that had not yet been recalled, despite them alerting the FDA about the unsafe product.

Because FDA did not have mandatory recall authority, their only recourse for this matter was asking the manufacturer to conduct a voluntary recall, a process that an unscrupulous manufacturer could refuse. In this case, with Congressman Kim and FDA’s help, the manufacturer complied and the small business was refunded.

Congressman Kim is the Ranking Member on the Military Personnel Subcommittee, and a member of the House Armed Services Committee, the Foreign Affairs Committee, and the Select Committee on China. More information about Congressman Kim’s accessibility, his work serving New Jersey’s 3rd Congressional District, and information on newsletters and his monthly town halls can be found on his website by clicking here.