DHHS has declared a public health emergency over the Zika virus, and authorized emergency use of diagnostic tests. (Copy here)
SUMMARY: The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. § 360bbb- 3. On February 26, 2016, the Secretary determined that there is a significant potential for 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 Zika virus.
On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
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Dated: February 26, 2016. Sylvia M. Burwell
Secretary
[FR Doc. 2016-04624 Filed: 3/1/2016 8:45 am; Publication Date: 3/2/2016]
What is the legal basis for this?
§360bbb–3. Authorization for medical products for use in emergencies
(a) In general
(1) Emergency uses
Notwithstanding sections 355, 360(k), and 360e of this title and section 262 of title 42, and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b) of this section, of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).[snip]
(b) Declaration of emergency
(1) In general
The Secretary may declare an emergency justifying the authorization under this subsection for a product on the basis of—
- (A) a determination by the Secretary of Homeland Security 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;
- (B) a determination by the Secretary of Defense 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
- (C) a determination by the Secretary of a public health emergency under section 247d of title 42 that affects, or has a significant potential to affect, national security, and that 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.
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(c) Criteria for issuance of authorization
The Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Director of the National Institutes of Health and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the circumstances of the emergency involved), the Secretary concludes—
- (1) that an agent specified in a declaration under subsection (b) of this section can cause a serious or life-threatening disease or condition;
- (2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that—
(A) the product may be effective in diagnosing, treating, or preventing—
(i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a product authorized under this section, approved or cleared under this chapter, or licensed under section 262 of title 42, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and(B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product;
- (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; and
- (4) that such other criteria as the Secretary may by regulation prescribe are satisfied.
(d) Scope of authorization
An authorization of a product under this section shall state—
- (1) each disease or condition that the product may be used to diagnose, prevent, or treat within the scope of the authorization;
- (2) the Secretary’s conclusions, made under subsection (c)(2)(B) of this section, that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product; and
- (3) the Secretary’s conclusions, made under subsection (c) of this section, concerning the safety and potential effectiveness of the product in diagnosing, preventing, or treating such diseases or conditions, including an assessment of the available scientific evidence.
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This is the key language from 42 U.S.C. 247D – PUBLIC HEALTH EMERGENCIES
42 USC 247d
(a) Emergencies
If the Secretary determines, after consultation with such public health officials as may be necessary, that–(1) a disease or disorder presents a public health emergency; or
(2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.
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