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) 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:
    ``(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.''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.

Summary: (This measure has not been amended since it was passed by the Senate on October 26, 2015.  Improving Regulatory Transparency for New Medical Therapies Act (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs. This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately. For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later. (Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant. (Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.