H1N1 (Swine Flu) FDA Action
(05/13/2009)
The FDA is actively participating in the joint federal emergency response to the current outbreak of the novel influenza A (H1N1) virus that has affected Americans across the United States - and many more globally. The possibility of a major disease outbreak in the U.S. presents the FDA with difficult decisions regarding the emergency use of potentially critically important products that are still under development and are awaiting FDA’s approval, or that have not yet been approved for use for some populations who might benefit from them. In these situations – and the current threat of 2009 H1N1 flu infections is one of them –the FDA assesses, among other things, whether the known and potential benefits of making certain diagnostic tests, devices, and therapies more readily available outweigh the known and potential risks. As part of FDA’s mission to promote and protect public health, we have been given authority to allow the emergency use of potentially effective products under certain circumstances, even though they have not yet been approved, provided there is a determination and declaration of emergency. Last week, after the Acting HHS Secretary issued emergency declarations, the FDA issued Emergency Use Authorizations (EUAs) requested by the U.S. Centers for Disease Control and Prevention (CDC) for two drugs to treat and prevent influenza under certain circumstances. The two drugs are Relenza (zanamivir) and Tamiflu (oseltamivir). Both are antiviral medications that are active against the H1N1 virus. Under these EUAs, based on the totality of scientific evidence available, the antiviral medications can be made available to more patient populations. For example, under the EUA, Tamiflu may be used in patients less than a year old. In addition, the EUAs authorize certain information pertaining to the emergency use of the medications to be made available through appropriate means. The EUAs also allow Tamiflu and Relenza to be dispensed and distributed without complying with all the prescription label requirements otherwise applicable to dispensed drugs. The EUAs also note that public health officials or other volunteers may distribute Tamiflu and Relenza to recipients in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. All of the terms and conditions of the EUAs must be followed for activities to fall within the scope of the EUAs. More details on these medicines and the emergency authorizations can be found on FDA’s website. FDA also granted two EUAs for diagnostic tests. The FDA determined that these tests may be effective in testing samples from individuals with suspected 2009 H1N1 infection. One EUA allows the CDC to distribute the uncleared and unapproved rRT-PCR 2009 H1N1 flu panel to public health and other qualified laboratories. FDA subsequently amended this EUA to allow additional types of respiratory specimens to be tested and to allow different critical test components to prevent shortages in test availability. In addition, FDA issued a second EUA to allow these same changes to be made to the FDA cleared CDC rRT-PCR Flu Panel which is used as the first tier test for patient specimens with suspected 2009 H1N1 virus infection. FDA also issued an EUA for certain NIOSH-certified N95 disposable respirators to permit these products to be deployed from the Strategic National Stockpile for use by the general public, including those performing work-related duties that might put them at an increased risk of exposure to the 2009 H1N1 flu virus. FDA amended this EUA with clarifications including that, if respirators are used in a work setting, Occupational Safety and Health Administration (OSHA) requirements still apply. And, finally, FDA’s Center for Biologics Evaluation and Research, a WHO collaborating Center for Influenza, is, along with CDC and other partners, growing the 2009 H1N1 flu virus in order to help prepare a reference strain and is also preparing other materials needed to be ready for vaccine manufacturing.
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