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For the FDA’s Emergency Use Authorization of Medical Products Guidance, go to www.fda.gov/oc/guidance/emergencyuse.html
1. What is an emergency use authorization?
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.
2. What is required before the FDA may issue an EUA?
The Act requires that, before an emergency use may be authorized, the Secretary of the Department of Health and Human Services (HHS) must declare an emergency justifying the emergency use, based on one of the following grounds:
(1) The Secretary of the Department of Homeland Security determines that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or
(2) The Secretary of the Department of Defense determines that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or
(3) The HHS Secretary determines that there is a public health emergency under the Public Health Service Act (PHS Act) that affects, or has a significant potential to affect, national security, and involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.
3. On what basis may the FDA issue an EUA?
Once the HHS Secretary has declared an emergency justifying the emergency use, the FDA Commissioner may authorize an emergency use only if, after consultation with the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) (to the extent feasible and appropriate given the circumstances of the emergency), he determines that certain statutory criteria have been met. Specifically, the Commissioner must conclude, as follows:
(1) That the agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition;
(2) That, based on the totality of scientific evidence available, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing—
(a) The serious or life threatening disease or condition, or
(b) A serious or life-threatening disease or condition caused by a product authorized under section 564, or approved, cleared, or licensed under the Act or PHS Act, for diagnosing, treating, or preventing the disease or condition referred to in paragraph (1) and caused by the agent specified in the declaration of emergency;
(3) That the known and potential benefits of the product 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 declaration; and
(4) That there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life threatening disease or condition.
An EUA may remain in effect for the duration (one year) of the declaration justifying the emergency use unless revoked. Both the declaration of an emergency and EUAs issued under that declaration may be renewed if justified after a year. The law requires the FDA to publish notice of each EUA in the Federal Register, each termination or revocation of an authorization, and an explanation of the reasons for the action.
4. Are there any limits on the use of an EUA product?
For unapproved products, the law requires the FDA Commissioner (to the extent practicable given the circumstances of the emergency) to establish certain conditions on an EUA that the Commissioner finds necessary or appropriate to protect the public health, and permits the Commissioner to establish other conditions that he finds necessary or appropriate to protect the public health. Such conditions may include a requirement to disseminate information to health care providers or authorized dispensers and prospective patients and other consumers regarding the EUA, the product’s significant known and potential benefits and risks and the extent to which such benefits and risks are unknown; available alternatives and their benefits and risks; and, for prospective patients and consumers, the option to accept or refuse the product and any consequences of refusal. Other conditions may include adverse event reporting and monitoring, data collection and analysis, and recordkeeping and records access.
For unapproved uses of approved products, certain of these conditions and other conditions may be required in an EUA.
Use of a product under an authorization must be consistent with any conditions imposed on the EUA.
5. What is the PREP Act?
The Public Readiness and Emergency Preparedness Act (PREP) provides compensation to individuals for serious physical injuries or deaths from pandemic, epidemic, or security countermeasures identified in a declaration issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d-6d).
If a person is given a countermeasure (such as a drug under an EUA) that is authorized for emergency use in a declaration made by the HHS Secretary, that person may be eligible for compensation for covered serious physical injury or death from the countermeasure under PREP.
For more information on the PREP Act and for information on filing a request for benefits, visit http://www.hrsa.gov/countermeasurescomp/.
6. What happens if the unapproved drugs or approved drugs for unapproved uses are distributed outside the scope of, or inconsistent with, the conditions of the EUA once it has been issued?
If the FDA issues an EUA to allow for the lawful distribution or dispensing of products for emergency use under certain circumstances and states do not distribute or dispense the countermeasures in accordance with the scope and conditions of the EUA, liability protections afforded by the PREP Act may be affected.
7. Are there EUAs currently in effect?
Yes. The FDA made available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the 2009 H1N1 flu virus under certain circumstances.
On April 27, 2009, the FDA issued EUAs for the use of certain antiviral products (Relenza®, Tamiflu®), N95 respirators, and for the rRT-PCR H1N1 Flu Virus Panel diagnostic test.
Additional information on these EUAs can also be found on www.fda.gov.
8. Why are EUAs needed to distribute 2009 H1N1 flu virus countermeasures?
While Tamiflu® and Relenza® have been previously approved by the FDA, certain aspects of the distribution and use of these products are not covered by their approved applications. An EUA allows these drugs to be legally distributed for the unapproved uses for which they are being authorized.
FDA has authorized emergency use of disposable N95 respirators by the general public during this declared emergency. These respirators may help to keep out germs that may be present in the air you breathe.
The rRT-PCR H1N1 Flu Virus Panel diagnostic test has not been approved or cleared by the FDA. An EUA allows this unapproved diagnostic kit to be legally distributed and used for the authorized purposes.
9. Will the EUAs cover 2009 H1N1 flu virus countermeasures not supplied by the Strategic National Stockpile?
In addition to the countermeasures supplied by the Strategic National Stockpile, Tamiflu and Relenza that are supplied via state and local governments are also covered by the EUAs, if the terms and conditions of the EUAs are met.
10. Will the recipient and health care provider fact sheets be available in multiple language translations?
Currently, the EUAs do not include translated versions of fact sheets.
11. Will states be distributing their own state-developed fact sheets for 2009 H1N1 flu virus countermeasures deployed from the Strategic National Stockpile for use under an EUA?
For the use of a countermeasure to be under an EUA, fact sheets as specifically authorized by the EUA will be distributed.
12. Will Project Areas need to plan to include information required under section 503(b)(2) of the Act on the label of the dispensed Tamiflu and Relenza?
No. The EUAs will permit that not all of the information required under section 503(b)(2) of the Act would appear on the label of the distributed Tamiflu and Relenza.
13. How do I report adverse events from using Tamiflu, Relenza and N95 respirators?
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.
--Online: www.fda.gov/MedWatch/report.htm
--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