Edited 04/16/2020 - Coronavirus Disease 2019 (COVID-19)
Facet has direct experience working with the FDA in relation to the development of COVID-19 therapeutics. Based on our experience and the information publicly available from FDA, we are providing the following guidance and recommendations.
FDA has issued a new guidance document that may be applicable to you:
FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the COVID-19 public health emergency. In a Q & A format, it addresses numerous direct and indirect ways FDA activities have been affected by COVID-19. It also indicates that, by in large, FDA is continuing to hold formal meetings (via teleconference), and adhere to stated application review timelines. See the guidance and/or ask Facet how your non-COVID-19 development program may be affected.
THINGS YOU NEED TO KNOW IF YOU:
- You are required to notify FDA if have a product shortage or supply issue. See: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/how-report-product-shortage-or-supply-issue-fda
- FDA has modified the post-marketing safety reporting requirements during this pandemic. See FDA’s guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-medical-products-and-dietary-supplements-during-pandemic
- FDA has provided several guidances on the necessary steps to ensure human safety and trial integrity: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders
- FDA’s website provides up-to-date information for Sponsors: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
- FDA has set different standards for diagnostics and therapeutics
- There are currently no FDA-approved diagnostics for COVID-19, but FDA has issued several Diagnostic Emergency Use Authorizations (EUAs): https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- There are currently no FDA-approved vaccines for COVID-19, but several companies are working to develop vaccine candidates. See clinicaltrials.gov for details.
- There are currently no FDA-approved therapies for COVID-19 or symptoms associated with the disease, but many companies are conducting clinical trials to investigate potential therapies. If you are interested in developing your therapeutic to treat COVID-19 or COVID-19 symptoms, FDA recommends you request a pre-IND consultation: https://www.fda.gov/drugs/investigational-new-drug-ind-application/pre-ind-consultation-program.
- At the present time, FDA is requiring controlled clinical trials to evaluate investigational drugs and biologics for the treatment of COVID-19.
- Unless your product is an antiviral, it is not enough to have a hypothesis that your drug/biologic will work in COVID-19 patients. FDA is likely to require relevant in vitro or in vivo data in models of coronavirus (e.g., SARS) to support an IND application for your investigational product for COVID-19.
- FDA is not currently granting expanded access (compassionate use) to unapproved non-antiviral therapeutics for COVID-19. The most appropriate way to approach the Agency with your potential therapeutic is to engage in a Pre-IND consultation.
If your company is making public statements about your product and COVID-19
FDA has and will continue to issue warning letters to organizations who are selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19. If you are developing a vaccine, biologic, drug, or medical device, you are required to adhere to FDA’s advertising and promotional regulations: https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products