A lawsuit alleging that the US FDA unlawfully detained a batch of acetaminophen API destined for CMO Gemini Pharmaceuticals could have significant impact on the drug industry's definition of an ‘end user.'
The case focuses on a 20,000kg batch of the API made by China firm Zhejiang Kangle Pharmaceutical that the FDA detained on August 11 on the basis that it did not come with details of all potential customers – end users - that would purchase it.
Importer H&M USA Inc. says the Food and Drug Administration (FDA) was “overreaching, arbitrary and capricious, unlawful and discriminatory” in its detention of the API and asks for a restraining order that would prevent the batch being transferred to the US Customs and Border Patrol.
The firm’s contention is that it did provide details of the end user - contractor Gemini Pharmaceutical – which had been due to buy the batch and for the production of OTC pain drugs for Rugby Laboratories.
H&M argues that the batch was labelled appropriately as “Caution: For manufacturing, processing, or repacking” in accordance with 21 CFR 201.122 and that the customer – Gemini – had contacted the FDA before the shipment was refused entry to confirm the impending transaction.
The lawsuit details several months of increasingly acrimonious correspondence between H&M, its chemicals broker, Gemini and the FDA compliance officer involved. One message, on September 25, requested that the batch was released because it was “desperately needed” to avoid a shutdown of Gemini’s facility in Commack, New York.
According to H&M the FDA’s response – on November 7 – was to restate that the batch “was refused because the product was for future/inventory use by the contract manufacturer, which is not permitted, compounded by the submission of incomplete end use documentation from only one of the contract manufacturer’s customers, did not qualify the shipment for the labelling exemption under 21 CFR 201.122.”
H&M USA Inc – which lists acetaminophen, benzocaine, lidocaine and phenylephrine alongside its core range of nutraceutical products on its website - did not respond to request for comment. A court date has not yet been set.
According to lawyer Dara Katcher Levy of Hyman, Phelps & McNamara, H&M may have a point. She wrote on the FDA Law Blog that: “OTC drug products are often manufactured by a single manufacturer for many private label distributors.
“As long as the finished product is ultimately compliant, FDA’s refusal to permit the import of otherwise lawful bulk drug product simply because a customer for the finished product had not yet been identified at the time of import is difficult to understand, and does not appear to be consistent with the agency’s regulations on drugs intended to be further manufactured.”
Katcher Levy added that: “It would be interesting to see whether an end-use statement that simply stated that the product would be manufactured and labelled in accordance with the pending OTC monograph would have sufficed in securing the release of this shipment.”