[114th Congress Public Law 89]
[From the U.S. Government Publishing Office]
[[Page 697]]
IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT
[[Page 129 STAT. 698]]
Public Law 114-89
114th Congress
An Act
To amend the Controlled Substances Act with respect to drug scheduling
recommendations by the Secretary of Health and Human Services, and with
respect to registration of manufacturers and distributors seeking to
conduct clinical testing. <<NOTE: Nov. 25, 2015 - [H.R. 639]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Improving
Regulatory Transparency for New Medical Therapies Act.>>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Improving Regulatory Transparency for
New Medical Therapies Act''.
SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA-APPROVED
DRUGS.
(a) Effective Date of Approval.--
(1) Effective date of drug approval.--Section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended
by adding at the end the following:
``(x) Date of Approval in the Case of Recommended Controls Under the
CSA.--
``(1) In general.--In the case of an application under
subsection (b) with respect to a drug 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, approval of such
application shall not take effect until the interim final rule
controlling the drug is issued in accordance with section 201(j)
of the Controlled Substances Act.
``(2) <<NOTE: Definition.>> Date of approval.--For purposes
of this section, with respect to an application described in
paragraph (1), the term `date of approval' shall mean the later
of--
``(A) the date an application under subsection (b)
is approved under subsection (c); or
``(B) the date of issuance of the interim final rule
controlling the drug.''.
(2) Effective date of approval of biological products.--
Section 351 of the Public Health Service Act (42 U.S.C. 262) is
amended by adding at the end the following:
``(n) Date of Approval in the Case of Recommended Controls Under the
CSA.--
``(1) In general.--In the case of an application under
subsection (a) with respect to a biological product 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, approval
[[Page 129 STAT. 699]]
of such application shall not take effect until the interim
final rule controlling the biological product is issued in
accordance with section 201(j) of the Controlled Substances Act.
``(2) <<NOTE: Definition.>> Date of approval.--For purposes
of this section, with respect to an application described in
paragraph (1), references to the date of approval of such
application, or licensure of the product subject to such
application, shall mean the later of--
``(A) the date an application is approved under
subsection (a); or
``(B) the date of issuance of the interim final rule
controlling the biological product.''.
(3) Effective date of approval of animal drugs.--
(A) In general.--Section 512 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by
adding at the end the following:
``(q) Date of Approval in the Case of Recommended Controls Under the
CSA.--
``(1) In general.--In the case of an application under
subsection (b) with respect to a drug 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, approval of such
application shall not take effect until the interim final rule
controlling the drug is issued in accordance with section 201(j)
of the Controlled Substances Act.
``(2) <<NOTE: Definition.>> Date of approval.--For purposes
of this section, with respect to an application described in
paragraph (1), the term `date of approval' shall mean the later
of--
``(A) the date an application under subsection (b)
is approved under subsection (c); or
``(B) the date of issuance of the interim final rule
controlling the drug.''.
(B) Conditional approval.--Section 571(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360ccc(d)) is amended by adding at the end the
following:
``(4)(A) In the case of an application under subsection (a)
with respect to a drug 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, conditional approval of such
application shall not take effect until the interim final rule
controlling the drug is issued in accordance with section 201(j)
of the Controlled Substances Act.
``(B) For purposes of this section, with respect to an
application described in subparagraph (A), the term `date of
approval' shall mean the later of--
``(i) the date an application under subsection (a)
is conditionally approved under subsection (b); or
``(ii) the date of issuance of the interim final
rule controlling the drug.''.
(C) Indexing of legally marketed unapproved new
animal drugs.--Section 572 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360ccc-1) is amended by
adding at the end the following:
``(k) <<NOTE: Determination.>> In the case of a request under
subsection (d) to add a drug to the index under subsection (a) with
respect to a drug
[[Page 129 STAT. 700]]
for which the Secretary provides notice to the person filing the request
that the Secretary intends to issue a scientific and medical evaluation
and recommend controls under the Controlled Substances Act, a
determination to grant the request to add such drug to the index shall
not take effect until the interim final rule controlling the drug is
issued in accordance with section 201(j) of the Controlled Substances
Act.''.
(4) Date of approval for designated new animal drugs.--
Section 573(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360ccc-2(c)) is amended by adding at the end the
following:
``(3) <<NOTE: Time period.>> For purposes of determining
the 7-year period of exclusivity under paragraph (1) for a drug
for which the Secretary intends to issue a scientific and
medical evaluation and recommend controls under the Controlled
Substances Act, the drug shall not be considered approved or
conditionally approved until the date that the interim final
rule controlling the drug is issued in accordance with section
201(j) of the Controlled Substances Act.''.
(b) Scheduling of Newly Approved Drugs.--Section 201 of the
Controlled Substances Act (21 U.S.C. 811) is amended by inserting after
subsection (i) the following:
``(j)(1) <<NOTE: Deadline. Regulations.>> With respect to a drug
referred to in subsection (f), if the Secretary of Health and Human
Services recommends that the Attorney General control the drug in
schedule II, III, IV, or V pursuant to subsections (a) and (b), the
Attorney General shall, not later than 90 days after the date described
in paragraph (2), issue an interim final rule controlling the drug in
accordance with such subsections and section 202(b) using the procedures
described in paragraph (3).
``(2) The date described in this paragraph shall be the later of--
``(A) the date on which the Attorney General receives the
scientific and medical evaluation and the scheduling
recommendation from the Secretary of Health and Human Services
in accordance with subsection (b); or
``(B) the date on which the Attorney General receives
notification from the Secretary of Health and Human Services
that the Secretary has approved an application under section
505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic Act
or section 351(a) of the Public Health Service Act, or indexed a
drug under section 572 of the Federal Food, Drug, and Cosmetic
Act, with respect to the drug described in paragraph (1).
``(3) A rule issued by the Attorney General under paragraph (1)
shall become immediately effective as an interim final rule without
requiring the Attorney General to demonstrate good cause therefor.
The <<NOTE: Comments. Hearing.>> interim final rule shall give
interested persons the opportunity to comment and to request a hearing.
After the conclusion of such proceedings, the Attorney General shall
issue a final rule in accordance with the scheduling criteria of
subsections (b), (c), and (d) of this section and section 202(b).''.
(c) Extension of Patent Term.--Section 156 of title 35, United
States Code, is amended--
(1) in subsection (d)(1), in the matter preceding
subparagraph (A), by inserting ``, or in the case of a drug
product
[[Page 129 STAT. 701]]
described in subsection (i), within the sixty-day period
beginning on the covered date (as defined in subsection (i))''
after ``marketing or use''; and
(2) by adding at the end the following:
``(i)(1) <<NOTE: Notification. Effective date.>> For purposes of
this section, if the Secretary of Health and Human Services provides
notice to the sponsor of an application or request for approval,
conditional approval, or indexing of a drug product for which the
Secretary intends to recommend controls under the Controlled Substances
Act, beginning on the covered date, the drug product shall be considered
to--
``(A) have been approved or indexed under the relevant
provision of the Public Health Service Act or Federal Food,
Drug, and Cosmetic Act; and
``(B) have permission for commercial marketing or use.
``(2) <<NOTE: Definition.>> In this subsection, the term `covered
date' means the later of--
``(A) the date an application is approved--
``(i) under section 351(a)(2)(C) of the Public
Health Service Act; or
``(ii) under section 505(b) or 512(c) of the Federal
Food, Drug, and Cosmetic Act;
``(B) the date an application is conditionally approved
under section 571(b) of the Federal Food, Drug, and Cosmetic
Act;
``(C) the date a request for indexing is granted under
section 572(d) of the Federal Food, Drug, and Cosmetic Act; or
``(D) the date of issuance of the interim final rule
controlling the drug under section 201(j) of the Controlled
Substances Act.''.
SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is
amended by adding at the end the following:
``(i)(1) <<NOTE: Deadlines.>> For purposes of registration to
manufacture a controlled substance under subsection (d) for use only in
a clinical trial, the Attorney General shall register the applicant, or
serve an order to show cause upon the applicant in accordance with
section 304(c), not later than 180 days after the date on which the
application is accepted for filing.
``(2) <<NOTE: Notification.>> For purposes of registration to
manufacture a controlled substance under subsection (a) for use only in
a clinical trial, the Attorney General shall, in accordance with the
regulations issued by the Attorney General, issue a notice of
application not later than 90 days after the application is accepted for
filing. Not later than 90 days after the date on which the period for
comment pursuant to such notice ends, the Attorney General shall
register the applicant, or serve an order to show cause upon the
applicant in accordance with section 304(c), unless the Attorney General
has granted a hearing on the application under section 1008(i) of the
Controlled Substances Import and Export Act.''.
SEC. 4. RE-EXPORTATION AMONG MEMBERS OF THE EUROPEAN ECONOMIC
AREA.
Section 1003 of the Controlled Substances Import and Export Act (21
U.S.C. 953) is amended--
(1) in subsection (f)--
(A) in paragraph (5)--
(i) by striking ``(5)'' and inserting
``(5)(A)'';
[[Page 129 STAT. 702]]
(ii) by inserting ``, except that the
controlled substance may be exported from a second
country that is a member of the European Economic
Area to another country that is a member of the
European Economic Area, provided that the first
country is also a member of the European Economic
Area'' before the period at the end; and
(iii) by adding at the end the following:
``(B) Subsequent to any re-exportation described in
subparagraph (A), a controlled substance may continue to be
exported from any country that is a member of the European
Economic Area to any other such country, if--
``(i) the conditions applicable with respect to the
first country under paragraphs (1), (2), (3), (4), (6),
and (7) are met by each subsequent country from which
the controlled substance is exported pursuant to this
paragraph; and
``(ii) the conditions applicable with respect to the
second country under paragraphs (1), (2), (3), (4), (6),
and (7) are met by each subsequent country to which the
controlled substance is exported pursuant to this
paragraph.''; and
(B) in paragraph (6)--
(i) by striking ``(6)'' and inserting
``(6)(A)''; and
(ii) by adding at the end the following:
``(B) <<NOTE: Deadline.>> In the case of re-exportation
among members of the European Economic Area, within 30 days
after each re-exportation, the person who exported the
controlled substance from the United States delivers to the
Attorney General--
``(i) <<NOTE: Certification.>> documentation
certifying that such re-exportation has occurred; and
``(ii) information concerning the consignee,
country, and product.''; and
(2) by adding at the end the following:
``(g) Limitation.--Subject to paragraphs (5) and (6) of subsection
(f) in the case of any controlled substance in schedule I or II or any
narcotic drug in schedule III or IV, the Attorney General shall not
promulgate nor enforce any regulation, subregulatory guidance, or
enforcement policy which impedes re-exportation of any controlled
substance among European Economic Area countries, including by
promulgating or enforcing any requirement that--
``(1) re-exportation from the first country to the second
country or re-exportation from the second country to another
country occur within a specified period of time; or
[[Page 129 STAT. 703]]
``(2) information concerning the consignee, country, and
product be provided prior to exportation of the controlled
substance from the United States or prior to each re-exportation
among members of the European Economic Area.''.
Approved November 25, 2015.
LEGISLATIVE HISTORY--H.R. 639:
---------------------------------------------------------------------------
HOUSE REPORTS: No. 114-41, Pt. 1 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 161 (2015):
Mar. 16, considered and passed House.
Oct. 26, considered and passed Senate, amended.
Nov. 16, House concurred in Senate amendment.
<all>