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H.R. 4710 (116th): Pharmaceutical Independence Long-Term Readiness Reform Act


The text of the bill below is as of Oct 17, 2019 (Introduced). The bill was not enacted into law.


I

116th CONGRESS

1st Session

H. R. 4710

IN THE HOUSE OF REPRESENTATIVES

October 17, 2019

(for himself and Mrs. Hartzler) introduced the following bill; which was referred to the Committee on Armed Services, and in addition to the Committees on Veterans' Affairs, and Financial Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL

To direct the Secretary of Defense to include in each national defense strategy steps to strengthen the United States industrial base and to assure an uninterrupted supply of medicines, and for other purposes.

1.

Short title

This Act may be cited as the Pharmaceutical Independence Long-Term Readiness Reform Act.

2.

United States medicine supply chain

(a)

National defense strategy

The Secretary of Defense shall include, in each national defense strategy under section 113(g) of title 10, United States Code, steps to be taken to assure the provision of medicines to enable combat readiness and force health protection.

(b)

Report to Congress

Not later than one year after the date of the enactment of this Act, the Secretary of Defense, in consultation with the heads of other appropriate Federal departments and agencies, shall submit to Congress a report on vulnerabilities to the United States medicine supply chain. Such report shall include—

(1)

an identification of any finished drugs and their essential components including raw materials, chemical components and active ingredients necessary for the manufacture of medicines whose supply is at risk of disruption during a time of war or national emergency;

(2)

an identification of shortages of finished drugs essential for combat readiness and force protection;

(3)

an identification of the defense and geopolitical contingencies that are sufficiently likely to arise that may disrupt, strain, compromise, or eliminate supply chains of medicines and their essential components and recommendations for reasonable preparation for the occurrence of such contingencies;

(4)

an assessment of the resilience and capacity of the current supply chain and industrial base to support national defense upon the occurrence of the contingencies identified in paragraph (3), including with respect to—

(A)

the manufacturing capacity of the United States;

(B)

gaps in domestic manufacturing capabilities including non-existent, extinct, threatened, and single-point-of-failure capabilities; and

(C)

supply chains with single points of failure and limited resiliency;

(5)

legislative, regulatory, and policy changes necessary to avoid, or prepare for, contingencies identified in the report; and

(6)

recommendations to diversify supply away from complete dependency on sources of supply in competitor countries and politically unstable countries that may cut off United States supply, and address critical bottlenecks and mitigate single points of failure and limited resilience.

(c)

Preference for medicines

(1)

In general

Except as provided in paragraph (2) and under section 1107a(d) of title 10, United States Code, the Secretary of Defense and the Secretary of Veterans Affairs—

(A)

may only acquire and purchase American-made and Federal Drug Administration approved raw materials, medicines, and vaccines for the Department of Defense; and

(B)

shall use the authorities under the Defense Production Act to acquire and purchase such raw materials, medicines, and vaccines, recognizing the national security vulnerabilities of a dependency on a foreign medical supply chain.

(2)

Exception

Paragraph (1) does not apply in any case where the Secretary of Defense determines that a shortage of any raw material, medicine, or vaccine is such that it becomes unavoidable to acquire such raw material, medicine, or vaccine from a trusted foreign supplier.

(3)

American-made

For purposes of this subsection, the term American-made supplied from, created, or supplied by the United States, including any territory or possession of the United States.