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S. 204 (115th): Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

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The text of the bill below is as of Jan 24, 2017 (Introduced).

Summary of this bill

Source: Republican Policy Committee

S. 204 amends the Federal Food, Drug, and Cosmetic Act to exempt, from specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must report annually to the Food and Drug Administration (FDA) on any use of the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website.

The bill limits the liability of a sponsor, manufacturer, prescriber, or dispenser that …

II

115th CONGRESS

1st Session

S. 204

IN THE SENATE OF THE UNITED STATES

January 24, 2017

(for himself, Mr. Barrasso, Mr. Blunt, Mr. Boozman, Mrs. Capito, Mr. Cochran, Mr. Corker, Mr. Cotton, Mr. Crapo, Mr. Cruz, Mr. Daines, Mr. Donnelly, Mr. Enzi, Mrs. Fischer, Mr. Flake, Mr. Gardner, Mr. Graham, Mr. Grassley, Mr. Hatch, Mr. Heller, Mr. Hoeven, Mr. Inhofe, Mr. Isakson, Mr. Kennedy, Mr. King, Mr. Lankford, Mr. Lee, Mr. Manchin, Mr. McCain, Mr. McConnell, Mr. Moran, Ms. Murkowski, Mr. Paul, Mr. Perdue, Mr. Risch, Mr. Rounds, Mr. Rubio, Mr. Sasse, Mr. Shelby, Mr. Sullivan, Mr. Tillis, Mr. Toomey, Mr. Wicker, and Mr. Young) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

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 Trickett Wendler Right to Try Act of 2017.

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—

(1)

the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that—

(A)

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

(B)

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

(2)

the possession or use of an experimental drug, biological product, or device—

(A)

that is described in subparagraphs (A) and (B) of paragraph (1); and

(B)

for which the patient has received a certification from a physician, who is in good standing with the physician's certifying organization or board, that the patient has exhausted, or otherwise does not meet qualifying criteria to receive, any other available treatment options.

(b)

No liability or use of outcomes

(1)

No liability

Notwithstanding any other provision of law, no liability shall lie against a producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental drug, biological product, or device for the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is in compliance with subsection (a).

(2)

No use of outcomes

Notwithstanding any other provision of law, the outcome of any production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that was done in compliance with subsection (a) shall not be used by a Federal agency reviewing the experimental drug, biological product, or device to delay or otherwise adversely impact review or approval of such experimental drug, biological product, or device.

(c)

Definitions

In this section:

(1)

Biological product

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)

Device; drug

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)

Experimental drug, biological product, or device

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)

Phase 1 clinical investigation

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)

Terminal illness

The term terminal illness has the meaning given to such term in the State law specified in subsection (a)(1)(B).