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.
Premier Consulting 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?
Initial Inquiries to the FDA for COVID-19 Products
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:
- Dedicated review teams: At the Center for Drug Evaluation and Research (CDER), a multi-specialty, multi-disciplinary team led by the Division of Antivirals in the Office of Infectious Diseases reviews inquiries and requests related to COVID-19.
- Centralized email addresses: The FDA has created dedicated email addresses for initial COVID-related inquiries.
- Quick review team assignment: Upon receipt, development requests are quickly triaged and assigned to the appropriate review team within CDER, the Center for Biologics Evaluation and Research (CBER), or the Center for Devices and Radiological Health (CDRH). The Agency aims to respond to Sponsors’ requests within a day.
- Prioritization of interactions: The review teams prioritize Sponsor interactions based on the product’s scientific merits, stage of development, and identification as a possible priority product. According to the FDA, “Because the overriding objective is to develop safe and effective treatments for American patients as soon as possible, the strongest proposals will go to the front of the line on the basis of scientific merit.”
- Manufacturing alternatives: The FDA is working closely with applicants and other regulatory agencies to expedite quality assessments for COVID-19 treatments and to transfer manufacturing to alternative sites to avoid supply disruption.
FDA Process for COVID-19 Treatments
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.
Pre-IND vs. pre-EUA Submissions
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.
Premier Consulting 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