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FDA’s Disparate Treatment Of Fibrinogen Products ‘Defies Logic,’ Octapharma Contends

 
• By Brenda Sandburg

Suit says FDA wrongly classified the fibrinogen products of three blood centers as ‘blood components’ exempt from clinical trials while classifying Octapharma’s Fibryga as a ‘blood derivative’ subject to clinical studies.

Blood cells
US FDA sued over its classification of fibrinogen blood products • Source: Shutterstock

Octapharma USA Inc is seeking an injunction to vacate the US Food and Drug Administration’s approval of plasma-derived fibrinogen products sponsored by three blood centers. It claims they should have undergone clinical testing as the agency required for approval of Octapharma’s Fibryga (human fibrinogen concentrate).

In a 14 September suit filed in the US District Court for the District of Columbia, Octapharma says the agency decided to regulate the blood centers’ products as blood components, allowing them to skip the submission of clinical studies demonstrating their safety, purity, and potency

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