FDA Finalizes Rule for Detaining Suspicious Drug Imports

May 30, 2014

The FDA now has the power to stop any pharmaceutical import it suspects could be adulterated or misbranded, according to a final rule that implements the agency’s new import authority.

The final rule, released Thursday, stems from a provision in the 2012 FDA Safety and Innovation Act that gives FDA officials power to detain suspected drugs. Agency officials already had the ability to detain foods and medical devices.

Under the rule, an FDA field inspector can block a drug import for up to 20 days, while the importer has five days in which to appeal the detention order. The agency can detain the products for an additional 10 days if more time is needed to initiate legal action or institute injunction proceedings. The rule goes into effect June 28.

The FDA received six comments on the proposed rule issued last July, but made no changes to the draft. The agency did respond to concerns of commenters in the rule’s summary.

One commenter noted that the term adulteration was too broad. The agency replied that it can’t change the administrative detention standard itself, and that the 1938 FD&C Act has provisions that characterize adulteration and misbranding of pharmaceuticals. “Because these terms are already well characterized, we do not believe it is necessary or appropriate to further define or modify the meaning of these terms for the purpose of this rule,” the agency said.

Another commenter was concerned that detaining pharmaceuticals could create a shortage and would be withheld from patients without due process. The agency responded that the rule gives importers an opportunity for an informal hearing within five working days after an appeal is filed. While preventing drug shortages is a priority at the agency, the FDA also is concerned about introducing adulterated or misbranded drugs into the supply chain, the summary reads.

One expert believes the new rule could create havoc for industry because agency inspectors won’t be consistent in their approaches to detaining products.

The rule enables field inspectors to detain the drugs instead of going through the agency’s compliance office, William Nychis, senior regulatory advisor for the consulting firm FDAImports.com and a 40-year agency veteran, said. The problem is “the people out in the field are generally not specialists,” he said. “Giving this authority to the field investigators will only lead to more confusion and more wrong calls.”

Don’t let the FDA detain your imports. Learn how to challenge the FDA’s findings, order Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings.