The U.S. Food and Drug Administration, in response to requests
from the U.S. Centers for Disease Control and Prevention, has
issued Emergency Use Authorizations (EUAs) to make available to
public health and medical personnel important diagnostic and
therapeutic tools to identify and respond to the swine flu virus
under certain circumstances. The agency issued these EUAs for
the use of certain Relenza and Tamiflu antiviral products, and
for the rRT-PCR Swine Flu Panel diagnostic test.
The EUA authority allows the FDA, based on the evaluation of
available data, to authorize the use of unapproved or uncleared
medical products or unapproved or uncleared uses of approved or
cleared medical products following a determination and
declaration of emergency, provided certain criteria are met. The
authorization will end when the declaration of emergency is
terminated or the authorization revoked by the agency.
Currently, Relenza is approved to treat acute uncomplicated
illnesses due to influenza in adults and children 7 years and
older who have been symptomatic for less than two days, and for
the prevention of influenza in adults and children 5 years and
older. Tamiflu is approved for the treatment and prevention of
influenza in patients 1 year and older.
The EUAs allow for Tamiflu also to be used to treat and prevent
influenza in children under 1 year, and to provide alternate
dosing recommendations for children older than 1 year. In
addition, under the EUAs, both medications may be distributed to
large segments of the population without complying with the
label requirements otherwise applicable to dispensed drugs, and
accompanied by written information pertaining to the emergency
use. They may also be distributed by a broader range of health
care workers, including some public health officials and
volunteers, in accordance with applicable state and local laws
and/or public health emergency responses.
In authorizing an EUA for the rRT-PCR Swine Flu Panel diagnostic
test, the FDA has determined that it may be effective in testing
samples from individuals diagnosed with influenza A infections,
whose virus subtypes cannot be identified by currently available
tests. This EUA allows the CDC to distribute the swine flu test
to public health and other qualified laboratories that have the
needed equipment and the personnel who are trained to perform
and interpret the results.
The test amplifies the viral genetic material from a nasal or
nasopharyngeal swab. A positive result indicates that the
patient is presumptively infected with swine flu virus but not
the stage of infection. However, a negative result does not, by
itself, exclude the possibility of swine flu virus infection.
The EUA authority is part of Project BioShield, which became law
in July 2004.
Health care professionals and consumers may report serious
adverse events (side effects) or product quality problems with
the use of this product to the FDA's MedWatch Adverse Event
Reporting program either online, by regular mail, fax or phone.
--Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088
For more information:
FDA’s Emergency Use Authorization of Medical Products Guidance,
Source: FDA Newsroom