[Congressional Record Volume 161, Number 168 (Monday, November 16, 2015)]
[House]
[Pages H8212-H8213]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT
Mr. GRIFFITH. Mr. Speaker, I ask unanimous consent to take from the
Speaker's table the bill (H.R. 639) 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,
with the Senate amendment thereto, and concur in the Senate amendment.
The Clerk read the title of the bill.
The SPEAKER pro tempore. The Clerk will report the Senate amendment.
The Clerk read as follows:
Senate amendment:
Strike all after the enacting clause and insert the
following:
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) 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 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) 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) 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) In the case of a request under subsection (d) to add
a drug to the index under subsection (a) with respect to a
drug 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) 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) 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 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 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) 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) 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:
[[Page H8213]]
``(i)(1) 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) 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)'';
(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) 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) 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
``(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.''.
Mr. GRIFFITH (during the reading). Mr. Speaker, I ask unanimous
consent that the reading of the Senate amendment be dispensed with.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Virginia?
There was no objection.
The SPEAKER pro tempore. Is there objection to the original request
of the gentleman from Virginia?
There was no objection.
A motion to reconsider was laid on the table.
____________________