Proposed Rule Would Let FDA Destroy Detained Imports

The FDA has released a proposed rule that would allow it to destroy certain drug imports that have been refused admission into the U.S., the agency’s latest attempt to boost the integrity of the U.S. drug supply chain.

The rule, released Monday, allows FDA to implement its authority to destroy an imported drug valued at $2,500 or less if it was detained for being adulterated, unapproved or misbranded. Such an action would be a stark contrast from the current system, which gives owners 90 days to take back drugs that were refused entry into the U.S.

“There is currently little deterrence to prevent sellers from sending violative drugs or resending previously refused drugs into the United States,” a summary of the rule reads.

The FDA hopes the threat of destruction will deter the importation of adulterated or misbranded drugs in the first place.

The agency will send a written notice to the owner of the affected drugs, who can request a hearing to plead its case against destroying their products. The decision on whether to destroy drug products will be made separately from the decision to refuse admittance into the U.S., the summary reads.

The drug’s owner would be liable for the storage and destruction costs of its products, the summary notes, and failure to pay could result in a lien against future imports.

The FDA doesn’t foresee the ruling having a negative economic impact on importers. “The number of expected destructions per year along with the very small value per event implies that this burden will not be significant,” the summary reads.

The U.S. Treasury could raise the $2,500 threshold to a higher amount if it chooses, the agency said.

After the rule is finalized, drug importers will have 30 days until it goes into effect.

The new authority was mandated in the 2012 FDA Safety and Innovation Act (FDASIA). Under this authority, the FDA last year issued a proposed rule granting detention authority for drugs. Currently inspectors can detain devices and food they believe are adulterated or misbranded, but not drugs. The agency plans to issue a final rule by this July and have it go into effect by August.

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