Within the pharmaceutical industry, it has long been understood that better addressing infectious diseases without a current vaccine or treatment option requires shorter regulatory approval processes. New drugs typically take up to 12 months to receive approval, while supplemental applications for additional use of an approved drug for a new disease or as part of a new combination therapy can take up to 10 months. These long review times can delay access to much-needed therapies.
At the same time, due diligence must be performed to ensure that new vaccines and treatments are safe and efficacious. In response, many regulatory bodies are taking a closer look at where processes can be streamlined.
Within the U.S. Food and Drug Administration (FDA), the Pre-Investigational New Drug Application (Pre-IND) consultation program, which was introduced in 1988, was designed to
“facilitate and foster early communications between the [FDA] and potential sponsors of new therapeutics ... for the treatment of bacterial, fungal, and viral infections; opportunistic infections; emerging infections ...”
Programs such as this involve more detailed feedback and earlier, closer collaboration with the agency, taking some of the guesswork out of submitting an application.
Advice can be requested for data-related questions to support the rationale for testing a drug in humans, study design, requirements for an Investigational New Drug (IND) application, initial drug development plans and regulatory requirements for demonstrating safety and efficacy.
COVID-19 is a perfect example of a novel disease for which there is an urgent need for both vaccines and therapies, with a matching response by many pharmaceutical and biotech organizations that have begun rapid development. To help reduce the application review timelines, the FDA issued guidance regarding Pre-IND meeting requests for COVID-19 drugs and biological products in May and established a multispecialty, multidisciplinary team to focus on the review of drug development proposals.
As we work with organizations on COVID-19 projects, we’ve been asked for guidance on Pre-IND meetings, including when to start talking to the agency. According to Suzanne Fleming, Regulatory Affairs Manager at our parent company, FHI 360, the earlier, the better:
“Pre-IND meetings are generally requested approximately two months prior to a desired meeting date because there are a lot of competing products for FDA review at the moment. Because the FDA has processed so many of these, they may have valuable advice for the sponsor with any complex issues they may have or what tools, such as specific analytical tools that could help with study design, they would like to see used in the study.”
FDA recommendations for COVID-19 drug development discussions include:
- Initiate discussions under a Pre-IND meeting, not a pre-emergency use authorization (pre-EUA), request
- Ensure all general information is provided (i.e., drug name, description of active ingredient, proposed indication, known or suspected mechanism of action, etc.)
- Provide data and information for risk assessment (i.e., formulation, pharmacology and toxicology data from nonclinical studies, etc.)
- Submit information to ensure acceptable quality (i.e., dosage adjustments for situations such as intubation, stability data, identity, purity, etc.)
- Follow the specific recommendation in the guidance for antiviral and inhalational drugs
Unsure when or how to start having discussions with the FDA? Contact our team to leverage our experience in rapid study start-up for infectious diseases.
