News & Events
Dear Health Care Professionals Letter Regarding 2009 H1N1 Flu Virus
Dear Colleague:
As part of our ongoing efforts to keep you informed, we want to make you aware of FDA’s Emergency Use Authorizations (EUAs) concerning the 2009 H1N1 Flu Virus (Swine Flu).
An Emergency Use Authorization (EUA) may be issued by the Food and Drug Administration (FDA) to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.
Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act), amended by the Project BioShield Act of 2004, permits authorization of such products for use in diagnosing, treating, or preventing serious or life-threatening diseases or conditions caused by biological, chemical, radiological, or nuclear agents, if certain statutory criteria are met.
In late April and early May, FDA issued four Emergency Use Authorizations in response to requests from the Centers for Disease Control and Prevention (CDC). Three of these Emergency Use Authorizations make available to public health and medical personnel for emergency use two FDA-approved drugs, Relenza and Tamiflu, for the treatment and prevention of the 2009-H1N1 Flu Virus, and an rRT-PCR test for diagnosing infection with the virus. The fourth authorizes the emergency use of certain personal respiratory protection devices, specifically disposable respirators certified by CDC’s National Institute for Occupational Safety and Health, known as N95 respirators deployed from the National Strategic Stockpile.
Antiviral Emergency Use Authorizations
Tamiflu (Oseltamivir phosphate)
The authorized oseltamivir phosphate products are as follows:
Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules
Tamiflu (oseltamivir phosphate) oral suspension
Oseltamivir phosphate products are approved and indicated for the treatment of uncomplicated acute illness due to influenza infections in patients 1 year and older who have been symptomatic for no more than 2 days. Oseltamivir phosphate products are also approved and indicated for the prophylaxis of influenza in patients 1 year and older.)
1) The above oseltamivir phosphate products are authorized for use in patients less than 1 year old. Such products are also authorized for use at later time points (i.e., patients who are symptomatic for more than 2 days) and for in patients sick enough to require hospitalization (i.e., patients who do not have "uncomplicated acute illness" per se).
2) The above oseltamivir phosphate products labeled consistent with the manufacturer's label are authorized to be distributed under this EUA. Such products are authorized to be distributed or dispensed without the requisite prescription label information under section 503(b)(2) of the Act (e.g., name and address of dispenser, serial number, date of prescription or of its filling, name of prescriber, name of patient, if stated on prescription, directions for use and cautionary statements, if contained in the prescription).
3) The above oseltamivir phosphate products may include products that are deployed from the Strategic National Stockpile (SNS) and that are authorized to have their expiration date extended under the federal government's Shelf Life Extension Program (SLEP).
4) The above oseltamivir phosphate products are authorized to be accompanied by the following written information pertaining to the emergency use, which are authorized to be made available to health care providers and recipients:
Fact Sheet for Health Care Providers
Fact Sheet for Patients and Recipients
Tamiflu Letter for Emergency Use Authorization
Relenza (Zanamivir)
The authorized zanamivir products are as follows:
Relenza (zanamivir) Inhalation Powder
Zanamivir products are approved and indicated for the treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than 2 days. Zanamivir products are also approved and indicated for prophylaxis of influenza in adults and pediatric patients 5 years of age and older.
1) The above zanamivir products are authorized for use at later time points (i.e., patients who are symptomatic for more than 2 days) and for in patients sick enough to require hospitalization (i.e., patients who do not have "uncomplicated acute illness" per se).
2) The above zanamivir products labeled consistent with the manufacturer's label are authorized to be distributed under this EUA. Such products are authorized to be distributed or dispensed without the requisite prescription label information under section 503(b)(2) of the Act (e-g., name and address of dispenser, serial number, date of prescription or of its filling, name of prescriber, name of patient, if stated on prescription, directions for use and cautionary statements, if contained in the prescription).
3) The above zanamivir products are authorized to be accompanied by the following written information pertaining to the emergency use, which are authorized to be made available to health care providers and recipients:
Fact Sheet for Health Care Providers
Relenza Letter for Emergency Use Authorization
Under the authorizations, both medications may be distributed with information pertaining to emergency use to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs. 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 or public health emergency responses.
Medical Device Emergency Use Authorizations
rRT-PCR Swine Flu Panel diagnostic test
FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A 2009-H1N1 infections, whose viral subtype 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 appropriately trained personnel.
The test amplifies the viral genetic material from a human sample. A positive result indicates that the patient is presumptively infected with the 2009-H1N1 Flu Virus, but it doesn’t identify the stage of infection. A negative result does not, by itself, exclude the possibility of 2009-H1N1 Flu Virus infection.
Disposable N95 Respirators from the Strategic National Stockpile
FDA has authorized the emergency use by the general public of disposable N95 respirators certified by NIOSH from the SNS. Some of these N95 respirators are also FDA-cleared devices. The term "general public" is broadly defined and includes people performing work-related duties. In a work setting, OSHA requirements also apply to these N95 respirators.
For clarification purposes, these respirators may also be referred to as Personal protective equipment (PPE). PPE is any type of respiratory protection device (face mask or respirator), glove, or clothing that acts as a barrier between infectious materials and the skin, mouth, nose, or eyes (mucous membranes). When used properly, personal protective equipment can help prevent the spread of infection from one person to another.
More information is available on our Personal Protective Equipment page.
Vaccine
At present, there are no licensed vaccines approved for this new H1N1 influenza virus.
Consumer Protection
The U.S. Food and Drug Administration and the Federal Trade Commission are alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. The agencies are also advising operators of offending web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.
Consumers and health care professionals are urged to report any suspected fraudulent products or criminal activity relating to FDA regulated products associated with H1N1 Flu Virus (Swine Flu), including the names of web sites that may be offering these products for sale, to the FDA by visiting our Fraudulent Flu Products Reporting page.
MedWatch
Health care professionals may report serious adverse events (side effects) to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone. Please include the name of the product, the manufacturer, and the model and lot number (if know, for medical devices).
--Online: MedWatch Online Voluntary Reporting Form (3500)
--Regular Mail: Download postage-paid FDA Form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088
For additional information:
FDA’s 2009 H1N1 (Swine) Flu Virus
FDA’s Emergency Use Authorization of Medical Products Guidance
If you have any questions, contact us at the numbers listed below.
Sincerely,
Beth Fritsch, R.Ph., M.B.A.
Beth.Fritsch@fda.hhs.gov
301-827-4460
David Banks, R.Ph., Ph.D.
David.Banks@fda.hhs.gov
301-827-4460