AAEI Says FDA Should Automatically Release Goods Upon Ok of NDA/BLA/ANDA
Goods should, as a matter of policy, be automatically released from FDA detention upon approval of the New Drug Application/Therapeutic Biologic Application (BLA)/Abbreviated New Drug Approvals are approved, said the American Association of Exporters and Importers in comments on the FDA's Draft Guidance for Industry on Pre-Launch Activities Importation Requests (PLAIR) for drugs. AAEI also said importers should be allowed to distribute product as soon as the NDA/BLA/ANDA is approved, without additional FDA action, such as release from detention.
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It also said industry should be allowed to submit the PLAIR 90 days before PDUFA (Prescription Drug User Fee Act) reports, instead of the 60 days proposed in the regulation. It also:
- Requested clarification that further processing (e.g. packaging and labeling) be allowed during FDA detention.
- Suggested that FDA consider the creation of an affirmation of compliance code and qualifier of PLAIR/NDA.
- Asked FDA to create separate PLAIR number for compliance and not rely on the NDA number, which it said creates a potential barrier for the Ports in that they currently have to investigate the history of the shipment to get PLAIR information.
- On the 6-month detention, AEI asked that if the FDA is not able to meet the PDUFA date the detention be extended by an equal length of time to the missed deadline.
- Asked that a PLAIR be valid for line extensions (as opposed to just new NDAs) and also that multiple shipments and entries be allowed under a PLAIR instead of just one.
- Said more flexibility would be advantageous to the trade, particularly for multiple processing points and warehouses. It said the FDA and industry should rely on cGMPs, GDPs and internal controls to ensure that the process follows PLAIR guidelines and NDA/ANDA/BLA requirements.
- It recommended FDA consider expanding the program beyond finished human health products to also include animal health products, API and medical devices.