FDA, is That Your “Final Answer?” Never Say Never When it Comes to Reversing FDA Import Refusals
Tags: compliance officers, detainment, drugs, FDA, final rule, importers, medicine, misbranded, refusal, regulation
If you remember only one thing about FDA-related legal matters involving imported products it should be this: Even if FDA issues a “final” FDA refusal on a legal matter, it is still possible to 1) prove that the FDA got it wrong, and 2) convince FDA to reverse itself.
For instance, in late 2011 FDA detained multiple shipments of children’s medicine being imported by a multi-national drug company. FDA alleged that the drugs appeared to be misbranded and unapproved. Eventually FDA refused all of the shipments. FDAImports.com reviewed the matter and discovered the compliance officer was requiring submission of a specific piece of information that had no basis in law or regulation. In this case, we identified that all of the necessary information had been submitted by the importer to FDA and that the compliance officer was asking for information that did not exist (and that FDA regulation did not require to exist).
Most importers are much too busy to know each and every FDA regulation inside and out and to spend time attempting to decipher cryptic demands from FDA Compliance Officers.
After a bit of back and forth (and appeals to senior agency decision makers) FDA rescinded all of the refusals and released the entries worth over $250,000.
Never say never, even if FDA gives their “final answer.”
