 The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D. As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic. We understand the need to adapt and pivot to support modification or development of these lifesaving tools as new variants of coronavirus are identified. Since the beginning of the pandemic, the U.S. Food and Drug Administration has anticipated the possible emergence of coronavirus variants. The FDA continues to monitor the identified and emerging variants circulating globally, as well as their detection in the U.S. We have been actively assessing the impact of new strains on authorized products and continue to work with medical product sponsors and our international partners to evaluate the impact that each variant may have on effectiveness or utility of authorized medical products. Our agency has had experience with evolving infectious diseases. Influenza vaccines and diagnostics are often modified each year to address the predicted predominant strains circulating globally. The agency has created and used regulatory processes that facilitate these updates. We will utilize our experience with influenza to help inform a path forward if SARS-CoV-2 variants emerge against which currently authorized vaccines are not sufficiently effective. Similarly, the FDA also has vast experience with HIV developing resistance to antiviral drugs and will follow regulatory pathways to quickly enable new antiviral drug development for resistant virus. We have already been communicating with individual medical product sponsors to provide information as they evaluate the impact of COVID-19 variants on their products. And as part of our commitment to a public and transparent process, the FDA is developing guidances for diagnostic, therapeutic and vaccine developers to help guide ongoing medical product development. For therapeutics, particularly virus-targeting monoclonal antibodies, we are considering approaches to help expedite drug development in this key area, including discussing appropriate regulatory flexibilities. We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the COVID-19 variants that have emerged, and we are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations. Relying on our growing experience with this class of drugs, our teams are discussing approaches to the generation and evaluation of pre-clinical, clinical and chemistry, manufacturing and controls data. For diagnostics, we have been monitoring for new mutations, identifying and working with developers of tests whose performance may be adversely impacted by them, and communicating with the public when helpful information becomes available. At this time, we believe the risk that these mutations will impact overall testing accuracy of molecular tests is low. Moving forward, we are considering expanding the role of in silico monitoring by sponsors prior to and following authorization to assess for mutations that impact the performance of the test, test designs to minimize the impact of new mutations and ways to label authorized products to be transparent about what we know the test can detect. For authorized vaccines, our teams are currently deliberating and discussing the types of data needed to support changes in the composition of the vaccine, either through altering the existing vaccine or through the addition of new vaccine component(s), including how sponsors could demonstrate immune response to new variants through streamlined clinical programs that still gather the crucial data the FDA needs to demonstrate effectiveness, but can be executed quickly to gather this data. To be clear, while we continue to develop an understanding of and address any impact of variants on FDA-regulated products, at this time, available information suggests that the authorized vaccines remain effective in protecting the American public against currently circulating strains of COVID-19. We believe these guidances will demonstrate our flexibility to work with individual sponsors to support their modification or development of products to fight COVID-19. The FDA's response to the COVID-19 pandemic continues to be an all-hands-on-deck effort to enable the agency to simultaneously address multiple public health needs. With emergence of multiple variants and their potential impact on the performance and efficacy of vaccines, therapeutics, and diagnostics, it is critical that the FDA is transparent about its thinking in this space so that all parties know they are receiving consistent advice and other individuals have insight into the agency's decision-making process. In addition to these guidances, the FDA is undertaking scenario planning to prepare us to anticipate and address impacts to products and supply chains as quickly as possible, no matter what path the pandemic takes in the next months. As we continue this process, we are committed to sharing this information with the public when it is ready. We are committed to identifying efficient processes for authorized products that may need to be modified, based on information on emerging variants. We do not believe there will be the need to start at square one with any of these products—we recognize we are in a pandemic and we need to arm health care providers with the most appropriate tools to fight this pandemic on the frontlines. We do not want to create obstacles to getting these tools to the frontlines. As with any evolving situation, we will be continuously monitoring the situation and updating our plans as more information becomes available. We are committed to communicating with you as we continue to determine the best paths forward. We urge Americans to continue to get tested, get their vaccines and follow important health measures—wash your hands, wear a mask and maintain social distance. | 
No comments:
Post a Comment