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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 481 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                 S. 481

To amend the Controlled Substances Act and the Federal Food, Drug, and 
  Cosmetic 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.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           February 12, 2015

  Mr. Hatch (for himself and Mr. Whitehouse) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
To amend the Controlled Substances Act and the Federal Food, Drug, and 
  Cosmetic 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.

    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.''.
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