IIB
115th CONGRESS
2d Session
H. R. 5811
IN THE SENATE OF THE UNITED STATES
June 20, 2018
Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes.
Postapproval study requirements
Purposes of study
Section 505(o)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(B)) is amended by adding at the end the following:
To assess a potential reduction in effectiveness of the drug for the conditions of use prescribed, recommended, or suggested in the labeling thereof if—
the drug involved—
is or contains a substance for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act; or
is a drug that has not been approved under this section or licensed under section 351 of the Public Health Service Act, for which an application for such approval or licensure is pending or anticipated, and for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act; and
the potential reduction in effectiveness could result in the benefits of the drug no longer outweighing the risks.
.
Establishment of requirement
Section 505(o)(3)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(C)) is amended by striking such requirement
and all that follows through safety information.
and inserting the following:
such requirement—
in the case of a purpose described in clause (i), (ii), or (iii) of subparagraph (B), only if the Secretary becomes aware of new safety information; and
in the case of a purpose described in clause (iv) of such subparagraph, if the Secretary determines that new effectiveness information exists.
.
Applicability
Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)) is amended by adding at the end the following new subparagraph:
Applicability
The conduct of a study or clinical trial required pursuant to this paragraph for the purpose specified in subparagraph (B)(iv) shall not be considered a new clinical investigation for the purpose of a period of exclusivity under clause (iii) or (iv) of subsection (c)(3)(E) or clause (iii) or (iv) of subsection (j)(5)(F).
.
New effectiveness information defined
Section 505(o)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(2)) is amended by adding at the end the following new subparagraph:
New effectiveness information
The term new effectiveness information, with respect to a drug that is or contains a controlled substance for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act, means new information about the effectiveness of the drug, including a new analysis of existing information, derived from—
a clinical trial; an adverse event report; a postapproval study or clinical trial (including a study or clinical trial under paragraph (3));
peer-reviewed biomedical literature;
data derived from the postmarket risk identification and analysis system under subsection (k); or
other scientific data determined to be appropriate by the Secretary.
.
Conforming amendments with respect to labeling changes
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) is amended—
in subparagraph (A)—
in the heading, by inserting or new effectiveness
after safety
;
by striking safety information
and inserting new safety information or new effectiveness information such
; and
by striking believes should be
and inserting believes changes should be made to
;
in subparagraph (B)(i)—
by striking new safety information
and by inserting new safety information or new effectiveness information
; and
by inserting indications,
after boxed warnings,
;
in subparagraph (C), by inserting or new effectiveness information
after safety information
; and
in subparagraph (E), by inserting or new effectiveness information
after safety information
.
Rule of construction
Nothing in the amendments made by this section shall be construed to alter, in any manner, the meaning or application of the provisions of paragraph (3) of section 505(o) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)) with respect to the authority of the Secretary of Health and Human Services to require a postapproval study or clinical trial for a purpose specified in clauses (i) through (iii) of subparagraph (B) of such paragraph (3) or paragraph (4) of such section 505(o) with respect to the Secretary’s authority to require safety labeling changes.
Passed the House of Representatives June 19, 2018.
Karen L. Haas,
Clerk