Regulatory review of pharmaceutical products from Chinese entities

(a)

Definitions

In this section:(1)

Chinese entity

The term Chinese entity means an entity organized under the laws of the People's Republic of China or otherwise subject to the jurisdiction of the Government of the People's Republic of China.(2)

Drug application

The term drug application means an application submitted under subsection (b) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262).(3)

PRC-, CCP-, or PLA-affiliated entity

(A)

In general

The term PRC-, CCP-, or PLA-affiliated entity means any entity that receives support directly or indirectly from the Government of the People’s Republic of China, the Chinese Communist Party, or the People’s Liberation Army, including—(i)an entity owned or controlled by the Government of the People’s Republic of China or an entity owned or controlled by such an entity; and(ii)an entity that has on its board of directors one or more individuals described in subparagraph (B) who collectively hold an ownership interest in the entity.(B)

Individuals described

An individual described in this subparagraph is—(i)an official of the Government of the People’s Republic of China, the Chinese Communist Party, or the People's Liberation Army; or(ii)an executive officer of an entity owned or controlled by the Government of the People’s Republic of China, including the president or vice president of, or any other executive officer who performs a policy-making function for, the entity.(4)

Secretary

The term Secretary means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.(b)

Review of certain new drug applications submitted on or after enactment

(1)

In general

The Secretary, in coordination with the Office of National Security of the Department of Health and Human Services, shall review each drug application submitted on or after the date of enactment of this Act by a sponsor that is a Chinese entity, or an entity licensing a product owned by a Chinese entity, to determine whether such sponsor is a PRC-, CCP-, or PLA-affiliated entity. In carrying out this paragraph, the Secretary may review any Drug Master File referenced by such an application.(2)

Denied approval of certain applications

The Secretary shall not approve any drug application submitted on or after the date of enactment of this Act if the Secretary has determined under paragraph (1) that the sponsor of such application is a PRC-, CCP-, or PLA-affiliated entity.(c)

Review of certain new drug applications submitted prior to enactment

(1)

In general

The Secretary, in coordination with the Office of National Security of the Department of Health and Human Services, shall review each drug application submitted during the period described in paragraph (2) to determine whether the sponsor of the application and, if applicable, the holder of the approved application, is a PRC-, CCP-, or PLA-affiliated entity. In carrying out this paragraph, the Secretary may review any Drug Master File referenced by such an application. (2)

Period described

The period described in this paragraph is the period beginning on January 1, 2016, and ending on the day before the date of enactment of this Act. (d)

Refusal of certain drugs offered for import

(1)

In general

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following;

(v)

Import of drugs sponsored by PRC-, CCP-, and PLA-Affiliated entities

(1)

In general

The Secretary shall furnish to the Commissioner of U.S. Customs and Border Protection a list of drugs for which the sponsor or holder of an approved application is determined under section 2(c) of the Securing America’s Drug Supply from Communist China Act to be a PRC-, CCP-, or PLA-affiliated entity. (2)

Refusal

If it appears that a drug imported or offered for import into the United States is a drug for which the sponsor or holder of an approved application is determined under section 2(c) of the Securing America’s Drug Supply from Communist China Act to be a PRC-, CCP-, or PLA-affiliated entity, then such drug shall be refused, except as provided in paragraphs (3) and (4), and the Commissioner of U.S. Customs and Border Protection shall destroy, without the opportunity for export, such drug. (3)

Compliance

(A)

In general

The Secretary shall establish a process under which the sponsor of a drug described in paragraph (2) or the holder of an approved application for such a drug, as applicable, may— (i) demonstrate to the Secretary that it is no longer a PRC-, CCP-, or PLA-affiliated entity; or (ii) within 180 days, sell the approved application for such drug to an entity that is not a PRC-, CCP-, or PLA-affiliated entity. (B)

Requirement

The process established under subparagraph (A) shall include the opportunity to appear before the Secretary and introduce testimony. (C)

Notification

If the Secretary is satisfied with the action taken under clause (i) or (ii) of subparagraph (A), the Secretary shall notify the Commissioner of U.S. Customs and Border Protection. (4)

Waiver

The Commissioner of U.S. Customs and Border Protection may waive the requirements of paragraph (2) and authorize the import of a drug described in such paragraph if the Secretary has determined that the refusal of the import would create or exacerbate a drug shortage in the United States. (5)

Definition of PRC-, CCP-, or PLA-affiliated entity

In this subsection, the term PRC-, CCP-, or PLA-affiliated entity has the meaning given such term in section 2(a) of the Securing America’s Drug Supply from Communist China Act.

(e)

Authorization of Appropriations

There is authorized to be appropriated to carry out this section and the amendments made by this section $5,000,000, to remain available until expended.