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

<DOC>





                                                       Calendar No. 245
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, Mr. Whitehouse, and Mrs. Murray) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

                            October 1, 2015

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Improving Regulatory 
Transparency for New Medical Therapies Act''.</DELETED>

<DELETED>SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA-APPROVED 
              DRUGS.</DELETED>

<DELETED>    (a) Effective Date of Approval.--</DELETED>
        <DELETED>    (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:</DELETED>
<DELETED>    ``(x) Date of Approval in the Case of Recommended Controls 
Under the CSA.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) the date an application under 
                subsection (b) is approved under subsection (c); 
                or</DELETED>
                <DELETED>    ``(B) the date of issuance of the interim 
                final rule controlling the drug.''.</DELETED>
        <DELETED>    (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:</DELETED>
<DELETED>    ``(n) Date of Approval in the Case of Recommended Controls 
Under the CSA.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) the date an application is approved 
                under subsection (a); or</DELETED>
                <DELETED>    ``(B) the date of issuance of the interim 
                final rule controlling the biological 
                product.''.</DELETED>
        <DELETED>    (3) Effective date of approval of animal drugs.--
        </DELETED>
                <DELETED>    (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:</DELETED>
<DELETED>    ``(q) Date of Approval in the Case of Recommended Controls 
Under the CSA.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) the date an application under 
                subsection (b) is approved under subsection (c); 
                or</DELETED>
                <DELETED>    ``(B) the date of issuance of the interim 
                final rule controlling the drug.''.</DELETED>
                <DELETED>    (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:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(i) the date an application under 
                subsection (a) is conditionally approved under 
                subsection (b); or</DELETED>
                <DELETED>    ``(ii) the date of issuance of the interim 
                final rule controlling the drug.''.</DELETED>
                <DELETED>    (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:</DELETED>
<DELETED>    ``(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.''.</DELETED>
        <DELETED>    (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:</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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:</DELETED>
<DELETED>    ``(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).</DELETED>
<DELETED>    ``(2) The date described in this paragraph shall be the 
later of--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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).</DELETED>
<DELETED>    ``(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).''.</DELETED>
<DELETED>    (c) Extension of Patent Term.--Section 156 of title 35, 
United States Code, is amended--</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(A) have been approved; and</DELETED>
        <DELETED>    ``(B) have permission for commercial marketing or 
        use.</DELETED>
<DELETED>    ``(2) In this subsection, the term `covered date' means 
the later of--</DELETED>
        <DELETED>    ``(A) the date an application is approved--
        </DELETED>
                <DELETED>    ``(i) under section 351(a)(2)(C) of the 
                Public Health Service Act; or</DELETED>
                <DELETED>    ``(ii) under section 505(b) or 512(c) of 
                the Federal Food, Drug, and Cosmetic Act;</DELETED>
        <DELETED>    ``(B) the date an application is conditionally 
        approved under section 571(b) of the Federal Food, Drug, and 
        Cosmetic Act;</DELETED>
        <DELETED>    ``(C) the date a request for indexing is granted 
        under section 572(d) of the Federal Food, Drug, and Cosmetic 
        Act; or</DELETED>
        <DELETED>    ``(D) the date of issuance of the interim final 
        rule controlling the drug under section 201(j) of the 
        Controlled Substances Act.''.</DELETED>

<DELETED>SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.</DELETED>

<DELETED>    Section 303 of the Controlled Substances Act (21 U.S.C. 
823) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

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.''.
                                                       Calendar No. 245

114th CONGRESS

  1st Session

                                 S. 481

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                            October 1, 2015

                       Reported with an amendment