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FDA and SARS
How We're Helping

• What is FDA doing to combat SARS?
• How is FDA helping to develop SARS diagnostic tools?
• How is FDA helping to develop effective treatments for SARS?
• How is FDA working to develop a vaccine for SARS?
• How is FDA helping to motivate industry to more actively participate in the process?
• What else is FDA doing to combat SARS?
• What are the symptoms, and what should people do if they exhibit those symptoms?

Q: What is FDA doing to combat SARS?

A: FDA is helping in the battle against SARS in four ways:

• First, we are working closely with other government agencies such as CDC and NIH, as well as with the private sector, to speed the development of reliable diagnostic tools that will help identify the microbiologic agent of SARS virus from patient specimens.
• Second, we are working to help develop safe and effective treatments for those patients suffering from SARS.
• Third, FDA is part of the team striving to develop a safe and effective SARS vaccine.
• Finally, FDA is working with manufacturers to assure adequate supplies of various medical products that would be needed in the event of a broader spread of SARS in the United States.
[SARS Home Page]

Q: How is FDA helping to develop SARS diagnostic tools?

A: The mission of FDA’s Center for Devices and Radiological Health (CDRH) is to guarantee the reliability of diagnostic tools, including those under development to identify the microbiologic agent responsible for SARS. CDRH is working closely with the CDC and private industry to help bring these essential diagnostic tools to the market quickly. And we are doing so with both urgency and thoroughness to assure that patients and medical practitioners understand what is known and unknown at present regarding these diagnostic tests. [SARS Home Page]

Q: How is FDA helping to develop effective treatments for SARS?

A: FDA’s Center for Drug Evaluation and Research (CDER) is helping in the task of identifying drugs that may be effective in combating the agent that causes SARS. CDER is working expeditiously with CDC and NIH to establish and put in place protocols for using these products to treat patients with SARS who meet certain medical criteria for inclusion in the protocols. Because of this close collaboration, the United States is now better ready to respond to any escalation of SARS cases. For example, FDA received draft protocols from CDC late on a Wednesday and was able to review and return our comments to them the next day. CDC submitted their final diagnostic protocol to us Friday at 5 p.m. and we gave them our approval by 8 p.m. that same day. [SARS Home Page]

Q: How is FDA working to develop a vaccine for SARS?

A: We are part of a team that is pursuing multiple potential vaccine development strategies. FDA’s Center for Biologics Evaluation and Research (CBER) is working with other government agencies and the private sector to address many of the most difficult early issues in vaccine development. In this process, CBER provides guidance on the use of animal test data and on safe manufacturing practices. CBER will also be a major participant in the design of clinical trials and in defining the needs of special populations (such as pregnant women). As this program is in its infancy, much painstaking work must be accomplished to assure that the development and manufacturing processes meet the standards required to produce the kind of safe and effective vaccines from which people have benefited so much over the years. To do any less would be a disservice to those who would be receiving the vaccine in the future. As such, it would be imprudent and unfair to over-promise at this time on any possible timeline for a SARS vaccine. [SARS Home Page]

Q: How is FDA helping to motivate industry to more actively participate in the process?

A: Private industry is already highly engaged in the fight against SARS. FDA and other government agencies are collaborating daily with industry on these issues. Secretary Thompson recently met with leaders of the US pharmaceutical and vaccine industries to thank them for their participation and collaboration and to reinforce that this is, and must remain, a top priority and a team effort. FDA is committed to providing industry with the kind of prompt regulatory oversight they need to help defeat SARS as soon as possible. [SARS Home Page]

Q: What else is FDA doing to combat SARS?

A: In addition to working with our sister agencies:

• FDA has already cleared and approved dozens of tests for use in differential diagnosis of acute respiratory syndromes and has put in place a post-market surveillance program to measure how well these tests are working. These tests do NOT diagnose SARS; rather they help to diagnose other conditions that may have symptoms similar to SARS. In this way SARS can be ruled out as the diagnosis in these patients.
• In addition, FDA is carefully tracking the scientific progress in defining, treating and, ultimately, defeating SARS to ensure that all FDA resources are aggressively, safely, and smartly deployed in the battle against this new virus. [SARS Home Page]

Q: What are the symptoms, and what should people do if they exhibit those symptoms?

• Symptoms include coughing, fever and shortness of breath.
• Individuals reporting symptoms who have recently returned to the United States from mainland China, Hanoi, Vietnam or Singapore should see a health care provider right away and inform them of their travel history.
• Clinicians should report such cases to their state health department or CDC Operations Center at 770-488-7100.
• The U.S. Department of Health and Human Services is not recommending masks for everyone. People should follow personal hygiene practices, such as washing your hands. Those with SARS symptoms can wear a mask and should cover their mouth and nose when sneezing.
• HHS is recommending people not make nonessential or elective travel to China, Hong Kong, Hanoi, Vietnam and Singapore. [SARS Home Page]