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H.R. 3012 (114th): Right to Try Act of 2015

The text of the bill below is as of Jul 9, 2015 (Introduced).


I

114th CONGRESS

1st Session

H. R. 3012

IN THE HOUSE OF REPRESENTATIVES

July 9, 2015

(for himself, Mr. Stutzman, and Mr. Gosar) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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 authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.

1.

Short title

This Act may be cited as the Right to Try Act of 2015.

2.

Use of unapproved medical products by patients diagnosed with a terminal illness

(a)

In general

Notwithstanding the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Controlled Substances Act (21 U.S.C. 801 et seq.), and any other provision of Federal law, the Federal Government shall not take any action to prohibit or restrict the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that—

(1)

is intended to treat a patient who has been diagnosed with a terminal illness; and

(2)

is authorized by, and in accordance with, State law.

(b)

Definitions

In this section:

(1)

The term biological product has the meaning given to such term in section 351 of the Public Health Service Act (42 U.S.C. 262).

(2)

The terms device and drug have the meanings given to such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

(3)

The term experimental drug, biological product, or device means a drug, biological product, or device that—

(A)

has successfully completed a phase 1 clinical investigation;

(B)

remains under investigation in a clinical trial approved by the Food and Drug Administration; and

(C)

is not approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 355, 360(k), 360(e)) or section 351 of the Public Health Service Act (42 U.S.C. 262).

(4)

The term phase 1 clinical investigation means a phase 1 clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).

(5)

The term terminal illness has the meaning given to such term in the State law specified in subsection (a)(2).