Recently, the Food and Drug Administration (FDA) detailed a new “special emergency program” for accelerating research and development of potential treatments for coronavirus disease (COVID-19). Under the coronavirus treatment acceleration program (CTAP), FDA says it is responding to requests from researchers and industry as rapidly as possible and by providing “ultra-rapid, interactive input on most development plans.”
More About CTAP
As described by the agency, CTAP “uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness.”
As of April 19, there were 72 active trials of therapeutic agents and another 211 development programs for therapeutic agents in the planning stages. FDA notes, given the urgent nature of the pandemic and the number of companies and researchers developing COVID-19 related therapies, the numbers may change frequently.
FDA specifically asks that any requests for drug products regulated by CDER for proposed COVID-19 uses to: http://COVID19-productdevelopment@fda.hhs.gov. FDA writes if you are developing a biological product regulated by CBER you may reach out directly to CBER at http://CBERProductJurisdiction@fda.hhs.gov. In addition, while not within the scope of the CTAP program, it has received a number of submissions regarding medical devices. FDA encourages device sponsors to contact CDRH directly at http://CDRHProductJurisdiction@fda.hhs.gov.
FDA goes on to explain CTAP in action and the “extraordinary surge” to get initial waves of studies underway. As described by the agency:
- Immediately upon receipt, triaged requests from developers and scientists seeking to develop or evaluate new drug and biologic therapies, getting the right FDA staff in touch with them and the work to get studies going fast. With a first wave of requests behind us, FDA will generally respond within a day.
- Provided ultra-rapid, interactive input on most development plans. Interactions have generally been prioritized based on a product’s scientific merits, stage of development, and identification as a possible priority product in consensus USG documents.
- Provided ultra-rapid protocol review – within 24 hours of submission, in some cases.
- Completed review of single patient expanded access requests around-the-clock – and generally within 3 hours.
- Worked closely with applicants and other regulatory agencies to expedite quality assessments for products to treat COVID-19 patients and to transfer manufacturing to alternative or new sites to avoid supply disruption.
As of April 16, 2020, FDA received 950 inquiries and proposals concerning COVID-19 related drug development. FDA says the strongest proposals will go the front of the line on the basis of scientific merit. It will be posting more detailed information concerning CTAP procedures and timelines soon.
FDA concludes by noting: “to the extent permitted by confidentiality laws, we’ll post summary statistics, keep the public updated, and link to public information about ongoing clinical trials and to summaries of drugs in clinical and preclinical development.”