119 S2986 IS: American Medicine Safety and Security Act U.S. Senate 2025-10-08 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II119th CONGRESS1st SessionS. 2986IN THE SENATE OF THE UNITED STATESOctober 8, 2025Mr. Cotton introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo establish certain conditions on employment and other work arrangements at the Food and Drug Administration to ensure the safety and security of drugs and devices.

1.

Short title

This Act may be cited as the American Medicine Safety and Security Act.

2.

Conditions for FDA employment and other work arrangements

(a)

Nationals of foreign countries of concern

No individual who is a national of a country of foreign concern shall be eligible for employment at, or for otherwise performing labor or services for remuneration for, the Food and Drug Administration.(b)

Reporting by certain employees and other workers

In the case of an employee of, or other individual performing labor or services for remuneration for, the Food and Drug Administration who has an immediate family member who is a national of a foreign country of concern, such employee or individual shall report such information, in accordance with a process established by the Commissioner of Food and Drugs. The Secretary of Health and Human Services shall immediately terminate the employment or agreement for labor or services for remuneration, as applicable, of any employee or other individual who fails to make a report required under this subsection.(c)

Limitation on subsequent employment and other work

(1)

In general

With respect to any individual who is employed by the Food and Drug Administration on or after the date of enactment of this Act, for the 10-year period immediately following such period of employment at the Food and Drug Administration, such individual may not be employed by, nor enter into an agreement to perform labor or services for remuneration or on a volunteer basis for, any entity based in a foreign country of concern.(2)

Contractual agreement

(A)

Existing employees

Effective on the date of enactment of this Act, each employee of the Food and Drug Administration hired prior to such date of enactment, as a condition of maintaining such employment, shall agree to the limitation on subsequent employment and other labor or services described in paragraph (1).(B)

New employees

Beginning on the date of enactment of this Act, each employee of the Food and Drug Administration hired after such date of enactment, as a condition of such employment, shall agree to the limitation on subsequent employment and other labor or services described in paragraph (1).(d)

Limitation on access to data

With respect to an employee of, or other individual performing labor or services for remuneration for, the Food and Drug Administration who is engaged in the review of applications for the approval, clearance, licensure, or authorization of drugs or devices, such employee or other individual shall not have access to drug or device information held by any department, division, or office of the Food and Drug Administration other than the department, division, or office employing the employee, or otherwise engaging the individual in the performance of labor or services for remuneration, if—(1)any member of the employee's or individual's immediate family is a national of a foreign country of concern; or(2)the employee or individual previously worked, at any time, as an employee or other individual performing labor or services for remuneration or on a volunteer basis, at an entity based in a foreign country of concern.(e)

Definitions

For purposes of this section—(1)the term foreign country of concern means the People's Republic of China, Russia, or Iran; and(2)the term immediate family, with respect to an individual, means the mother, father, sibling, or child of the individual.