Efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.
On March 31, 2020, the U.S. Food & Drug Administration (FDA) introduced a specially designed “emergency program”—dubbed the Coronavirus Treatment Acceleration Program (CTAP)—to provide patients with faster access to new COVID-19 treatments. The CTAP allows FDA to “move new therapies to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”
Given the rapidly increasing rate of COVID-19 confirmed cases and fatalities in the United States, efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.
Currently, a number of therapeutic options for the treatment of COVID-19 are being evaluated, including antiviral drugs (like remdesivir) that could treat this specific virus and so-called host targets (such as interleukin-6 receptor inhibitors) that may reduce lung inflammation or improve lung function for COVID-19 patients. As of March 31, FDA reported that 10 COVID-19 therapeutic agents are currently in active clinical trials and another 15 are in the planning stages. (FDA notes that given the urgent need to stem the COVID-19 pandemic and the substantial number of companies and researchers developing new therapies, the current “snapshot” figures are subject to frequent change.)
Benefits of the New Program
Under CTAP, staff from the Center for Drug Evaluation and Research as well as the Center for Biologics Evaluation and Research are providing “regulatory advice, guidance and technical assistance as quickly as possible.” According to the agency, the new program has enabled FDA to:
- Triage incoming requests from developers and scientists seeking to develop or evaluate new drug or biologic therapies, in part by connecting the developers and scientists with the appropriate contacts at FDA. (According to FDA, it will generally respond to such requests within a single day.);
- Provide “ultra-rapid, interactive input on most development plans,” prioritizing interactions based on, among other things, the product’s scientific merits and its stage of development;
- Provide “ultra-rapid” protocol review, within 24 hours of submission in most cases;
- Complete a review of a single patient expanded access request around-the-clock (generally within three hours); and
- Work closely with applicants and other regulatory agencies to (i) fast-track quality assessments for products designed to treat COVID-19 patients; and (ii) transfer manufacturing to alternative facilities to avoid supply disruption.
Operational Agency Changes to Support CTAP
FDA says it has taken a number of steps to ensure adequate agency support for the new emergency program. Among other things, FDA has:
- Redeployed medical and regulatory staff to teams dedicated to reviewing COVID-19 therapies and redeployed operations, policy and certain medical staff to support the overall effort of the CTAP;
- Involved senior management in the review of submissions;
- Streamlined the processes for developers and scientists to submit inquiries and requests; and
- Supplied healthcare providers and researchers with resources to assist them in submitting emergency requests to use investigational products for patients with COVID-19 infections.