Sarah J. Dash, President and CEO for the Alliance for Health Policy, conducted an interview with Dr. Anand Shah MD, Deputy Commissioner of Medical and Scientific Affairs at FDA. Members of the Press were invited to the virtual event for a conversation with Dr. Shah.
Dr. Shah leads the agency’s operations as related to medical and scientific affairs and is responsible for developing and leading high-priority FDA policy initiatives and oversees cross agency teams to support FDA’s public health mission.
He mentioned a number of actions that FDA has taken for COVID-19 related to testing. He explained that when the outbreak started in January, there were no established diagnostic tests since SARS-CoV-2 was a novel pathogen. FDA then used their Emergency Use Authorization (EUA) which allows FDA to authorize the limited emergency of promising medical countermeasures.
After realizing that additional FDA action was needed to meet the demand for COVID-19 diagnostic tests, FDA streamlined the EUA submission process. The agency has now issued EUAs for over 200 COVID-19 tests.
Dr. Shah reports that FDA is now focusing resources to support developing new therapies. In March, the agency launched the Coronavirus Treatment Acceleration Program (CTAP). This program enables the agency to triage all incoming requests and proposals for potential COVID-19 therapies. FDA is able to match innovators with the appropriate scientific and technical experts within the agency.
CTAP enables coordination within the agency and accelerates review timelines. It also help to improve communication with developers and ensures that they get the feedback they need to improve on protocol designs.
The federal government launched Operation Warp Speed, a collaboration between HHS and DOD with the goal to focus resources and investments towards developing, testing, and manufacturing medical countermeasures for COVID-19.
FDA in keeping an arm’s length from the current vaccine testing process issued a guidance document concerning COVID-19 vaccines on June 30, 2020 in advance of the initiation of large-scale clinical trials.
Since FDA released the guidance, developers are reaching important milestones for vaccine development. Several developers have reported promising results from Phase 1 trials in July 2020. As of August, developers are now recruiting and testing vaccine candidates in large-scale Phase 3 trials.
FDA is making efforts to accelerate access to quality PPE. FDA has issued numerous EUAs and one EUA authorizes PPE decontamination systems so that PPE, include particular respirators that can be reused. FDA has issued several guidance documents for products, such as sterilizers, disinfectant devices, air purifiers, and gowns.
As Dr. Shah stated, “FDA is committed to protecting consumers, however, the agency recognizes there may be bad actors seeking to take advantage of the public’s anxiety when it comes to dealing with counterfeit medical products.
To help protect consumers, FDA has initiated Operation Quack Hack. This is a cross agency effort led by FDA in collaboration with U.S. Customs Border Protection, FTC, and the Department of Justice. The goal is to proactively identify products making false COVID-19 claims.
FDA previously launched a Digital Health Innovation Action Plan to develop a regulatory framework. FDA has issued a temporary policy to expand patient access to digital health therapies, which includes computerized behavioral health therapy and has also exercised enforcement discretion for remote monitoring devices so patients are able to manage their chronic diseases during the pandemic.
Dr. Shad concluded by reporting that FDA recently launched the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) which will occur in three phases. This will include getting feedback from stakeholders, identifying key priority areas for change, and developing an implementation plan to introduce improvements and modernization to regulatory processes, operations, communications, and intra-agency coordination.