FDA Asks for Comments on Drug Administrative Detention Authority
The Food and Drug Administration is soliciting public comments on new regulations that will give the agency administrative detention authority with respect to drugs. The authority is granted to FDA under the Food and Drug Administration Safety and Innovation Act (FDSIA), signed into law by President Obama July 2012 (see 12062727). Section 709 of that law alters the Federal Food, Drug and Cosmetic Act -- which gives FDA administrative detention authority for food, tobacco products and devices -- by adding drugs to that list of items.
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The authority allows FDA inspectors to order products detained if, during an inspection, the product is found to be “adulterated or misbranded.” Detention may not exceed 20 days without approval from the "secretary." Maximum detention is 30 days. The owner of the product can also appeal a detention: Within five days of an appeal, the "secretary" must hold an informal hearing and by order confirm or revoke the detention. Read the existing administrative detention authority (here).
The FDSIA also requires the FDA to consult with stakeholders, including drug manufacturers, about the regulations, and issue a final rule before they take effect. The public docket for comments will be open for 30 days. Comments can be submitted through www.regulations.gov.
(Federal Register 4/9/13)