Legislation Introduced to Provide FDA Mandatory Recall Authority for Human and Animal Drugs

Chairman Edolphus Towns (D-NY) announced that he has introduced H.R. 5740, “a bill to provide for the mandatory recall of adulterated or misbranded drugs,” that would amend the Federal Food, Drug and Cosmetic Act (FD&C Act), to provide new recall authority to FDA.

Towns had stated his intention to introduce a mandatory recall bill during a committee hearing in May that examined Johnson & Johnson’s recall of children’s medicines (IPQ “In the News” June 2).

Under the bill, any individual or firm in the US licensed to produce drugs must inform FDA of the identity and location of one of its drugs if there is reason to believe that the product is “adulterated or misbranded” and there is “reasonable probability that the use or consumption of, or exposure to the drug…will cause a threat of serious adverse health consequences or death to humans or animals.”  It states that the notification process will be the subject of later regulation or guidance.

The provisions of the bill allow FDA to request a voluntary recall or order a mandatory recall when it has reason to believe a drug is “adulterated, misbranded, or otherwise in violation of this Act.”  The bill also outlines appeal processes for the manufacturing firm to follow if it disagrees with the action, and provides the ability for FDA to amend or vacate the order after the appeal.

H.R. 5740 has been referred to the House Committee on Energy and Commerce.

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H.R. 5740