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What to Expect from the FDA During COVID-19 Product Development
As the COVID-19 national emergency stretches on in the United States, the eyes of the pharmaceutical industry are trained on developing diagnostic, therapeutic, and preventive measures to combat the novel disease. Given the significance of the pandemic and the critical need, the FDA has developed new systems and policies for the rapid authorization of scientifically sound approaches to attenuate the coronavirus’s clinical impact.
Camargo has been consistently supporting Sponsors developing these products, and regular interactions with the FDA have given our team a front-row view of the Agency’s evolving response to the pandemic. So, what insights can we offer about the FDA’s handling of COVID-related programs, and how could it impact your development path?
The FDA recently launched a new program known as the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of potentially safe and effective life-saving treatments for COVID-19. CTAP aims to use every tool at the Agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate the efficacy and safety of the products. The Agency implemented the following streamlined processes to shorten timelines for Sponsor-Agency interactions:
As detailed in the recently released FDA Guidance titled “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products,” the FDA currently recommends that Sponsors seek initial advice for COVID-related products through pre-IND meetings, instead of a pre-EUA meeting. The FDA’s review and input will be prioritized based upon the data provided and the completeness of a submission, and the Agency has stated that feedback will generally be provided as Written Response Only.
The pre-IND process allows the FDA to provide efficient feedback on COVID-19 products in early stages of development that aren’t yet eligible for an EUA. Even if a product is currently in development under an active IND for a non COVID 19 indication, the FDA recommends that the Sponsor seek initial advice for the proposed COVID 19 indication under a new pre-IND, which can progress to a separate COVID-specific IND when appropriate. A second recently released FDA Guidance titled “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention” offers the Agency’s recommendations on Phase 2 and Phase 3 trials to support the clinical development of COVID-related products.
Communications between the FDA and Sponsors prior to an Emergency Use Authorization (EUA) request typically take place as pre-EUA meetings. However, under the new streamlined development process, pre-IND interactions for COVID-related products are being expedited, and the FDA considers a pre-IND meeting to be administratively equivalent to a pre-EUA meeting. Therefore, while a Sponsor can open an IND after a pre-IND interaction with the FDA, initiating discussions under a pre-IND does not preclude submission of an EUA request.
The issuance of an EUA, however, is distinct from authorization to use a product under an IND. An EUA provides only temporary permission to market a product specifically for its approved indication and is valid only for the duration of the declared national emergency. Once the COVID-19 national emergency ends, all COVID-related EUAs will be terminated under Section 564(b)(2) of the Federal Food, Drug, and Cosmetic Act. To continue marketing a product, a Sponsor will need to go through the formal IND/NDA approval process.
Camargo is actively supporting clients as they navigate the development of COVID-related therapeutic products through both the pre-IND and the pre-EUA pathways. Based on our extensive expertise, we can help move your development program forward by the quickest route available. Contact us to discuss your specific product development needs.
Cathy Gatza, PhD
Director of Regulatory Strategy
Tolu Junaid, MD, PhD
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Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.