Section 1 Short title
This Act may be cited as the “Right to Try Act of 2015”.
Right to Try Act of 2015
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.
Sec. 2 Use of unapproved medical products by patients diagnosed with a terminal illness
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—
is intended to treat a patient who has been diagnosed with a terminal illness; and
is authorized by, and in accordance with, State law.
Definitions— In this section:
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).
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).
The term experimental drug, biological product, or device means a drug, biological product, or device that—
has successfully completed a phase 1 clinical investigation;
remains under investigation in a clinical trial approved by the Food and Drug Administration; and
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).
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).
The term terminal illness has the meaning given to such term in the State law specified in subsection (a)(2).