Emergency 4 La Mod 3.1 5 Download REPACK
Sumiko Fagnoni
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.
Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.
On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024.
FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. The ending of the COVID-19 PHE will not impact FDA's ability to authorize medical countermeasures for emergency use. Existing COVID-19 EUAs will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. Read more about what happens to EUAs when a public health emergency ends.
The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.
The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUA subsequently issued by FDA is listed in the table below this blue box.
The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table on the page: Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products.
The dashboard provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under EUA during the COVID-19 public health emergency. After launching the FAERS Public Dashboard, click on the COVID-19 EUA link at the top of the home page to open the COVID-19 EUA FAERS Public Dashboard.
On February 4, 2020, the Secretary determined pursuant to section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).
PREP Act declaration: Effective September 28, 2022, the HHS Secretary amended the declaration first issued on October 10, 2008, and amended and republished effective January 1, 2016 for smallpox countermeasures and countermeasures against other orthopoxviruses pursuant to section 319F-3 of the Public Health Service Act to emphasize that the declaration applies to monkeypox virus, to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox (variola virus), monkeypox virus, and other orthopoxviruses in a declared emergency, and to extend the duration of the declaration. About PREP Act declarations
We provide Massachusetts residents and visitors emergency preparedness resources, emergency alerts, and information during and after emergencies and disasters. MEMA coordinates with federal, state and local government agencies, non-profits and businesses to prepare, respond and recover from emergencies and disasters.
DOT's goal is to place an ERG in every public emergency service vehicle nationwide. To date, more than16 million free copies have been distributed to the emergency response community through state emergency management coordinators. Members of the public may purchase a copy of the ERG through the GPO Bookstore and other commercial suppliers.
Any woman or girl of reproductive age may need emergency contraception to avoid an unwanted pregnancy. There are no absolute medical contraindications to the use of emergency contraception. There are no age limits for the use of emergency contraception. Eligibility criteria for general use of a copper IUD also apply for use of a copper IUD for emergency purposes.
Frequent and repeated ECP use may be harmful for women with conditions classified as medical eligibility criteria (MEC) category 2, 3,or 4 for combined hormonal contraception or Progestin-only contraceptives (POC). Frequent use of emergency contraception can result in increased side-effects, such as menstrual irregularities, although their repeated use poses no known health risks.
Emergency contraceptive pills were found to be less effective in obese women (whose body mass index is more than 30 kg/m2), but there are no safety concerns. Obese women should not be denied access to emergency contraception when they need it.
WHO recommends that a copper-bearing IUD, when used as an emergency contraceptive method, be inserted within 5 days of unprotected intercourse. This method is particularly appropriate for women who would like to start using a highly effective, long-acting, and reversible contraceptive method.
When inserted within 120 hours of unprotected intercourse, a copper-bearing IUD is more than 99% effective in preventing pregnancy. This is the most effective form of emergency contraception available. Once inserted, women can continue to use the IUD as an ongoing method of contraception, or may choose to change to another contraceptive method.
A copper-bearing IUD is a safe form of emergency contraception. It is estimated that there may be less than 2 cases of Pelvic Inflammatory Disease (PID) per 1000 users (3). (FP Global Handbook). The risks of expulsion or perforation are low.
Eligibility criteria for general use of a copper IUD also apply for use of a copper IUD for emergency purposes. Women with a condition classified as MEC category 3 or 4 (for example, with current PID, puerperal sepsis, unexplained vaginal bleeding, cervical cancer, or severe thrombocytopenia) for the copper IUD should not use a copper IUD for emergency purposes. In addition, a copper-bearing IUD should not be inserted for emergency contraception following sexual assault as the woman may be at high risk of a sexually transmitted infection such as chlamydia and gonorrhoea. A copper-bearing IUD should not be used as emergency contraception when a woman is already pregnant.
All women and girls at risk of an unintended pregnancy have a right to access emergency contraception and these methods should be routinely included within all national family planning programmes. Moreover, emergency contraception should be integrated into health care services for populations most at risk of exposure to unprotected sex, including post-sexual assault care and services for women and girls living in emergency and humanitarian settings.
(1) Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel.
Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, et al. Contraception. 2011 Oct;84(4):363-7. doi: 10.1016/j.contraception.2011.02.009. Epub 2011 Apr 2.
(2) Effect of BMI and body weight on pregnancy rates with LNG as emergency contraception: analysis of four WHO HRP studies.
Festin MP, Peregoudov A, Seuc A, Kiarie J, Temmerman M. Contraception. 2017 Jan;95(1):50-54. doi: 10.1016/j.contraception.2016.08.001. Epub 2016 Aug 12.