[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 639 Reported in House (RH)]
Union Calendar No. 26
114th CONGRESS
1st Session
H. R. 639
[Report No. 114-41, Part I]
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 2, 2015
Mr. Pitts (for himself, Mr. Pallone, and Mr. Gene Green of Texas)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committee on the Judiciary,
for a period to be subsequently determined by the Speaker, in each case
for consideration of such provisions as fall within the jurisdiction of
the committee concerned
March 16, 2015
Additional sponsor: Mrs. McMorris Rodgers
March 16, 2015
Reported from the Committee on Energy and Commerce with amendments
[Strike out all after the enacting clause and insert the part printed
in italic]
March 16, 2015
The Committee on the Judiciary discharged; committed to the Committee
of the Whole House on the State of the Union and ordered to be printed
[For text of introduced bill, see copy of bill as introduced on
February 2, 2015]
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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
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 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
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 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 recommend controls under the Controlled Substances
Act, a determination to grant the request to add such drug to the index
shall not take effect, and the Secretary shall not list the drug on
such index, 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 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 add the drug to 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 recommendations 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, 571, or 572 of the Federal Food, Drug, and
Cosmetic Act or section 351(a) of the Public Health Service Act
with respect to the drug described in paragraph (1).
``(3) A rule issued by the Attorney General under paragraph (1)
shall be in accordance with the procedures provided in subsection (a),
except that the rule shall become immediately effective as an interim
final rule without requiring the Attorney General to demonstrate good
cause therefor. After publication of the interim final rule, the
Attorney General shall issue a final rule in accordance with the
procedures provided in subsection (a).''.
(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; 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:
``(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.''.
Amend the title so as to read: ``A bill 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, and for other
purposes.''.
Union Calendar No. 26
114th CONGRESS
1st Session
H. R. 639
[Report No. 114-41, Part I]
_______________________________________________________________________
A BILL
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.
_______________________________________________________________________
March 16, 2015
Reported from the Committee on Energy and Commerce with amendments
March 16, 2015
The Committee on the Judiciary discharged; committed to the Committee
of the Whole House on the State of the Union and ordered to be printed