21 USC 360bbb3.

as may be necessary for the costs incurred by the Secretary in the procurement of countermeasures under this section.

SEC. 1603. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN

EMERGENCIES.

(a) IN GENERAL.-Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following section:

"SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

"(a) IN GENERAL.

"(1) EMERGENCY USES.-Notwithstanding sections 505, 510(k), and 515 of this Act and section 351 of the Public Health Service Act, 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 a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an 'emergency use').

"(2) APPROVAL STATUS OF PRODUCT.-An authorization under paragraph (1) may authorize an emergency use of a product that

"(A) is not approved, licensed, or cleared for commercial distribution under a provision of law referred to in such paragraph (referred to in this section as an 'unapproved product'); or

"(B) is approved, licensed, or cleared under such a provision, but which use is not under such provision an approved, licensed, or cleared use of the product (referred to in this section as an 'unapproved use of an approved product').

*(3) RELATION TO OTHER USES.-An emergency use authorized under paragraph (1) for a product is in addition to any other use that is authorized for the product under a provision of law referred to in such paragraph.

"(4) DEFINITIONS.-For purposes of this section:

"(A) The term 'biological product' has the meaning given such term in section 351 of the Public Health Service Act.

"(B) The term 'emergency use' has the meaning indicated for such term in paragraph (1).

"(C) The term 'product' means a drug, device, or biological product.

"(D) The term 'unapproved product' has the meaning indicated for such term in paragraph (2)(A).

"(E) The term 'unapproved use of an approved product' has the meaning indicated for such term in paragraph (2)(B).

"(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 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.

"(2) TERMINATION OF DECLARATION.—

"(A) IN GENERAL.-A declaration under this subsection shall terminate upon the earlier of—

"(i) a determination by the Secretary, in consultation with the Secretary of Defense, that the circumstances described in paragraph (1) have ceased to exist; or

"(ii) the expiration of the one-year period beginning on the date on which the declaration is made.

"(B) RENEWAL.-Notwithstanding subparagraph (A), the Secretary may renew a declaration under this subsection, and this paragraph shall apply to any such renewal.

"(C) DISPOSITION OF PRODUCT.-If an authorization under this section with respect to an unapproved product ceases to be effective as a result of a termination under subparagraph (A) of this paragraph, the Secretary shall consult with the manufacturer of such product with respect to the appropriate disposition of the product.

"(3) ADVANCE NOTICE OF TERMINATION.-The Secretary shall provide advance notice that a declaration under this subsection will be terminated. The period of advance notice shall be a period reasonably determined to provide

"(A) in the case of an unapproved product, a sufficient period for disposition of the product, including the return of such product (except such quantities of product as are necessary to provide for continued use consistent with subsection (f)(2)) to the manufacturer (in the case of a manufacturer that chooses to have such product returned); and

"(B) in the case of an unapproved use of an approved product, a sufficient period for the disposition of any labeling, or any information under subsection (e)(2)(B)(ii), as the case may be, that was provided with respect to the emergency use involved.

Federal Register,

"(4) PUBLICATION.-The Secretary shall promptly publish in the Federal Register each declaration, determination, publication. advance notice of termination, and renewal under this subsection.

"(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) 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 wellcontrolled 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 Act, or licensed under

section 351 of the Public Health Service Act, 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), 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), 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.

"(e) CONDITIONS OF AUTHORIZATION.—

“(1) UNAPPROVED PRODUCT.—

“(A) REQUIRED CONDITIONS.-With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the circumstances of the emergency, shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

"(i) Appropriate conditions designed to ensure that health care professionals administering the product are informed

"(I) that the Secretary has authorized the emergency use of the product;

"(II) of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and

"(III) of the alternatives to the product that are available, and of their benefits and risks.

"(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed

"(I) that the Secretary has authorized the emergency use of the product;

"(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

"(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

"(iii) Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the product.

"(iv) For manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records access by the Secretary, with respect to the emergency use of the product.

"(B) AUTHORITY FOR ADDITIONAL CONDITIONS.-With respect to the emergency use of an unapproved product, the Secretary may, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

"(i) Appropriate conditions on which entities may distribute the product with respect to the emergency use of the product (including limitation to distribution by government entities), and on how distribution is to be performed.

"(ii) Appropriate conditions on who may administer the product with respect to the emergency use of the product, and on the categories of individuals to whom, and the circumstances under which, the product may be administered with respect to such use.

"(iii) Appropriate conditions with respect to the collection and analysis of information, during the period when the authorization is in effect, concerning the safety and effectiveness of the product with respect to the emergency use of such product.±

"(iv) For persons other than manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records access by the Secretary, with respect to the emergency use of the product.

"(2) UNAPPROVED USE.-With respect to the emergency use of a product that is an unapproved use of an approved product:

"(A) For a manufacturer of the product who carries out any activity for which the authorization is issued, the Secretary shall, to the extent practicable given the circumstances of the emergency, establish conditions described in clauses (i) and (ii) of paragraph (1)(A), and may establish conditions described in clauses (iii) and (iv) of such paragraph.

"(B)(i) If the authorization under this section regarding the emergency use authorizes a change in the labeling of the product, but the manufacturer of the product chooses not to make such change, such authorization may not authorize distributors of the product or any other person to alter or obscure the labeling provided by the manufacturer.

"(ii) In the circumstances described in clause (i), for a person who does not manufacture the product and who

chooses to act under this clause, an authorization under this section regarding the emergency use shall, to the extent practicable given the circumstances of the emergency, authorize such person to provide appropriate information with respect to such product in addition to the labeling provided by the manufacturer, subject to compliance with clause (i). While the authorization under this section is effective, such additional information shall not be considered labeling for purposes of section 502. "(C) The Secretary may establish with respect to the distribution and administration of the product for the unapproved use conditions no more restrictive than those established by the Secretary with respect to the distribution and administration of the product for the approved use. "(3) GOOD MANUFACTURING PRACTICE.-With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the circumstances of the emergency, requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including such requirements established under section 501.

"(4) ADVERTISING.-The Secretary may establish conditions on advertisements and other promotional descriptive printed matter that relate to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), including, as appropriate

"(A) with respect to drugs and biological products, requirements applicable to prescription drugs pursuant to section 502(n); or

"(B) with respect to devices, requirements applicable to restricted devices pursuant to section 502(r).

"(f) DURATION OF AUTHORIZATION.—

"(1) IN GENERAL.-Except as provided in paragraph (2), an authorization under this section shall be effective until the earlier of the termination of the declaration under subsection (b) or a revocation under subsection (g).

"(2) CONTINUED USE AFTER END OF EFFECTIVE PERIOD.Notwithstanding the termination of the declaration under subsection (b) or a revocation under subsection (g), an authorization shall continue to be effective to provide for continued use of an unapproved product with respect to a patient to whom it was administered during the period described by paragraph (1), to the extent found necessary by such patient's attending physician.

"(g) REVOCATION OF AUTHORIZATION.—

"(1) REVIEW.-The Secretary shall periodically review the circumstances and the appropriateness of an authorization under this section.

"(2) REVOCATION.-The Secretary may revoke an authorization under this section if the criteria under subsection (c) for issuance of such authorization are no longer met or other circumstances make such revocation appropriate to protect the public health or safety.