The Food & Drug Administration ("FDA") has stated that it is responding to the 2009 H1N1 flu ("swine flu") virus threat by:

  • Working with other government agencies and manufacturers on a series of issues related to antiviral medications
  • Growing the swine flu virus and preparing to make vaccine seed lots to produce a safe and effective vaccine
  • Helping to prepare reagents for vaccine production and coordinating with other public health agencies for clinical development and testing
  • Accelerating access to new diagnostic tools for the swine flu virus

In response to requests from the U.S. Centers for Disease Control and Prevention ("CDC"), FDA has issued emergency use authorizations ("EUAs") to make important diagnostic and therapeutic tools available to the public. Under authority of the Federal Food, Drug, and Cosmetic Act, FDA can issue an EUA authorizing the use of a drug, device or biological product intended for use in an actual or potential emergency. EUA candidates include products that are not approved, cleared or licensed ("unapproved products") or uses of otherwise approved products that are not approved, cleared or licensed ("unapproved uses"). EUAs permit the use of unapproved products, or unapproved uses of approved products, following a declaration of a public health emergency, provided that certain statutory criteria are met.

Specifically, to authorize emergency use of a product, FDA must find that (i) the agent (in this case, the swine flu virus) can cause a serious or life-threatening disease or condition; (ii) based on the totality of the scientific evidence, it is reasonable to believe that the product may be effective in diagnosing, treating or preventing (a) this disease or condition, or (b) a serious or life-threatening condition caused by an FDA-regulated product (including an EUA product, or an approved, cleared or licensed product) used to diagnose, treat or prevent a disease or condition caused by such agent; (iii) the known and potential benefits of the product's use outweigh the known and potential risks of the product when used to diagnose, prevent or treat the serious or life-threatening disease or condition that is the subject of the emergency declaration; and (iv) there is no adequate, approved and available alternative to the product for the emergency application. The authorization will expire by statute within one year from the date of the emergency declaration, unless previously revoked by the agency.

On April 27, 2009, FDA issued four EUAs: two for the use of the approved antiviral drugs Relenza and Tamiflu for the treatment of the swine flu; one for a CDC-developed test for the presumptive diagnosis of infection with the swine flu virus; and one for specific disposable respirators, known as N-95 respirators. The EUAs for Relenza and Tamiflu allow for unapproved uses of the approved antiviral drugs. For example, Tamiflu is currently approved to treat uncomplicated acute illness due to influenza infections in patients one year and older who have been symptomatic for no more than two days, and for the prevention of influenza in patients one year and older. The EUA allows for Tamiflu to be used in patients less than one year old, and provides for alternate dosing recommendations, i.e., it permits for use at a later time beyond two days and/or in patients sick enough to require hospitalization. Under the EUAs, both Relenza and Tamiflu may be distributed with information pertaining to the emergency use, and do not need to comply with the statutory labeling requirements otherwise applicable to dispensed drugs.

The EUA for the rRT-PCR Swine Flu Panel diagnostic test allows the CDC to distribute the test to public health and other qualified laboratories that possess the appropriate equipment and trained personnel to interpret the results. According to FDA, the test amplifies the viral genetic material from a human sample, and a positive result indicates that the patient is presumptively infected with the swine flu virus, but does not provide information on the stage of the infection. A negative result, by itself, does not preclude the possibility of infection with the swine flu virus. (FDA subsequently amended this EUA to allow additional types of respiratory test specimens and different test components to prevent shortages in test availability.) The EUA for N-95 respirators covers certain disposable respirators certified by the National Institute for Occupational Safety and Health, with a minimum filtration efficiency classification of N-95. It permits the Department of Health and Human Services to deploy these products from the Strategic National Stockpile ("SNS") for use by the general public in reducing exposure to airborne germs. The SNS is the United States' national repository for medicines and medical supplies (such as antibiotics, antitoxins and airway maintenance supplies) and is designed to supplement and (re-)supply state and local public health agencies in the event of a national emergency.

On May 2, 2009, FDA issued a fifth EUA to allow use of a FDA-cleared diagnostic flu panel with certain specimen types and reagents not covered by the clearance. This test, the rRT-PCR Flu Panel, is used as a "first tier" test for patient specimens with suspected swine flu virus infection and is an integral component of the testing algorithm for the rRt-PCR Swine Flu Panel authorized for use under the April 27, 2009 EUA. Specifically, the rRt Flu Panel is used first to test specimens from individuals who may be infected with the swine flu virus; if the result is positive for influenza A and negative for certain seasonal human influenza subtypes, then the specimen is tested with the rRt-PCR Swine Flu Panel.

According to Dr. Joshua Sharfstein, FDA's Principal Deputy Commissioner and Acting Commissioner, the agency has initiated an "incident management approach" led by Dr. Jesse Goodman, FDA's Acting Chief Scientist and Deputy Commissioner for Scientific and Medical Programs. This approach includes the cross-cutting assignment of seven substantive teams such as the Vaccine Team, the Antiviral Team and the Personal Protective Equipment Team, with a management structure to coordinate operations, logistics and communications. The Vaccine Team is currently working to facilitate the availability of a safe and effective vaccine to protect the public from the swine flu virus, which involves growing and genetically engineering the virus, preparing reagents to help manufacturers produce and test the vaccine, and working with the CDC and other WHO centers on laboratory studies to provide an understanding of how well the seasonal flu vaccine might protect against the swine flu. FDA has also indicated that it is meeting with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities. Specifically, the agency is working to promptly review applications and/or supplements that could increase the number of vaccine manufacturers and therefore the vaccine supply. For example, on May 6, 2009 FDA announced that it approved a new manufacturing facility, owned and operated by sanofi pasteur, used to produce an influenza virus vaccine. This facility is approved for seasonal influenza vaccine production and could be used for the production of a vaccine against the swine flu virus.

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