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US lawmakers question FDA on complex generics approvals Posted 28/02/2020

A US Congress Committee have sent a letter to the US Food and Drug Administration (FDA) regarding concerns over the approval of complex generics.

Complex generics describe generic drugs that include a complex Active Pharmaceutical Ingredient (API), have a large or complex molecular composition or route of delivery, or are part of a complex drug-device combination. They are important for the treatment of a range of conditions including multiple sclerosis, schizophrenia, osteoporosis and chronic obstructive pulmonary disease (COPD). Examples of complex drugs include inhalers for asthma, eye drops and injectables.

At the beginning of 2019, then FDA Commissioner Scott Gottlieb outlined plans to promote access to complex generics [1]. This included a workshop on complex generics [2] and updated guidance for manufacturers [3].

However, the number of complex generics reaching the market remains limited. The House Committee on Energy and Commerce therefore wrote to current Commissioner Stephen Hahn requesting details of how the agency approves complex generics.

The letter raises particular concerns about the lengthy time taken to approve some of these products: ‘The length of time leading to the approval of some recently approved complex generics raises questions of whether additional actions may be necessary to encourage the development of these products’. As an example, FDA approved the first generic versions of EpiPen in 2018 – 10 years after they accepted the abbreviated new drug application (ANDA).

The letter requests information on complex generics, including:
• A list of all complex generics approved by FDA since October 2016.
• Copies of after-action reports or internal reviews related to the review of the aforementioned complex generics.
• The number of pre-ANDA meeting requests received by FDA since the program launched, as well as the number of meetings that were actually held.
• The number of ANDAs submitted for products discussed in the above meetings.
• The number of product development meeting requests for complex products, the number of meetings held, and the number of ANDAs submitted for products discussed during these meetings.
• A list of product-specific guidance published by FDA for complex drug products.

The ultimate aim of the request is to increase the number, and reduce the cost, of complex generics on the US market.

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA plans to advance development of complex generics in 2019 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 28]. Available from: www.gabionline.net/Guidelines/FDA-plans-to-advance-development-of-complex-generics-in-2019
2. GaBI Online - Generics and Biosimilars Initiative. FDA organizes workshop on complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 28]. Available from: www.gabionline.net/Guidelines/FDA-organizes-workshop-on-complex-generics
3. GaBI Online - Generics and Biosimilars Initiative. FDA planning more guidance for developers of complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 28]. Available from: www.gabionline.net/Guidelines/FDA-planning-more-guidance-for-developers-of-complex-generics

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