WASHINGTON D.C. – Congressman Andy Kim (NJ-03) has re-proposed his Protecting Americans from Unsafe Drugs Act today, aiming to grant the Food and Drug Administration (FDA) the compulsory recall authority over any defective or hazardous prescription and over-the-counter medications.
“Enacting this bill is crucial for shielding Americans from harmful medicines. Equipping the FDA with the necessary tools can avert the widespread use of products that could cause damage instead of delivering their intended benefits,” stated Congressman Kim. “Should this bill become law, it would enforce corporate accountability, ensuring that local businesses and pharmacies aren’t held responsible after purchasing and receiving substandard medicines. Moreover, it would spare small businesses and pharmacies the expense of storing these medications in their facilities to prevent them from reaching Americans. I call upon my fellow legislators from both parties in the House and Senate to pass this bill and safeguard Americans.”
The proposed legislation would grant the FDA the compulsory recall authority over all drugs – including hand sanitizer – that may result in severe health consequences or death. Bills granting mandatory recall authority for prescription and over-the-counter medications have been presented and approved in the House on several occasions. A comparable provision received bipartisan support in the House of Representatives in 2018 and was subsequently incorporated by the House Appropriations Committee into a bipartisan FY2021 proposal. Although the bill was approved as part of the House Passed America COMPETES Act, it was excluded from the CHIPS and Science Act. Currently, Congressman Kim’s bill aligns with the FDA compulsory recall authority proposal featured in the Biden Administration’s FY2024 budget announced last month.
At present, the FDA lacks compulsory recall authority, despite having held this authority for food products since 2011 and recently acquiring it for cosmetic products in the 2023 Omnibus bill. A former constituent and small business owner facing a $5 million loss due to contaminated hand sanitizer that had not been recalled, despite notifying the FDA about the dangerous product, brought this issue to Congressman Kim’s attention.
As the FDA lacked compulsory recall authority, its only option in this situation was to request the manufacturer to initiate a voluntary recall, which an unprincipled manufacturer could reject. In this instance, with the assistance of Congressman Kim and the FDA, the manufacturer complied, and the small business received a refund.
The Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety and efficacy of various products, including food, drugs, medical devices, and other consumer products. When the FDA determines that a product poses a health hazard, it may issue a recall. The process of an FDA recall generally involves the following steps:
- Identification of the problem: The FDA may receive reports of adverse events or other safety concerns related to a product. The agency may also conduct its own testing and analysis to identify potential problems.
- Classification of the recall: The FDA classifies recalls into three categories based on the level of health hazard posed by the product: Class I (most serious), Class II, or Class III (least serious).
- Notification of the public: Once the FDA has determined that a recall is necessary, it works with the company to issue a public notification, typically in the form of a press release. The notification will include information about the product, the reason for the recall, and any recommended actions for consumers.
- Removal of the product: The company will typically be responsible for removing the product from the market, either by recalling it from stores or by contacting customers directly. The FDA may also monitor the effectiveness of the recall to ensure that all affected products have been removed from circulation.
- Investigation and follow-up: The FDA will investigate the root cause of the problem and take any necessary actions to prevent similar issues from arising in the future. The agency may also conduct follow-up inspections of the company’s facilities to ensure that appropriate corrective actions have been taken.
It’s important to note that not all recalls are initiated by the FDA. Companies may also voluntarily recall products if they become aware of potential safety issues. Regardless of the origin of the recall, the FDA plays a critical role in ensuring that the public is informed and that appropriate actions are taken to protect public health.
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