Regulatory Focus™ > News Articles > FDA Seeks New Authority Through FDASIA to Administratively Detain Deficient Pharmaceuticals

FDA Seeks New Authority Through FDASIA to Administratively Detain Deficient Pharmaceuticals

Posted 08 April 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced that it will begin to solicit comments from industry and the public regarding a pending regulation that would expand its authority to administratively detain deficient pharmaceutical products.


The provision, found under 304(g) of the Federal Food Drug and Cosmetic Act (FD&C Act), has historically allowed FDA to detain two types of products if the agency suspects they are adulterated or misbranded: medical devices and tobacco products.

"If during an inspection conducted under section 374 of this title of a facility or a vehicle, a device or tobacco product which the officer or employee making the inspection has reason to believe is adulterated or misbranded is found in such facility or vehicle, such officer or employee may order the device or tobacco product detained … for a reasonable period which may not exceed twenty days," the law states. An additional ten days of detention may be authorized if additional time is needed to initiate enforcement actions.

Pharmaceuticals Achieve Parity

Notably absent from that authority, however, have been pharmaceutical products, which are subject to a more rigorous set of enforcement practices that requires FDA to have "probable cause" to seize a product.

Under the FDA Safety and Innovation Act (FDASIA) of 2012, FDA is provided with the same authority to detain drugs that it already has to detain devices and tobacco products.

"Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations in accordance with section 304(i) of the FD&C Act, as added by paragraph (2) of this subsection, to implement administrative detention authority with respect to drugs, as authorized by the amendments made by subsection (a)," FDASIA explains.

"Before promulgating such regulations, the Secretary shall consult with stakeholders, including manufacturers of drugs," it adds. FDA's 9 April 2013 Federal Register notice calling for comments is the start of that consultation process.

FDA will accept comments from industry and the public for 30 days. The subsequent regulatory notice will, according to the FDASIA statute, have a 60-day comment period.


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