[Congressional Record (Bound Edition), Volume 161 (2015), Part 12]
[Senate]
[Pages 16521-16522]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2748. Mr. PORTMAN (for Mr. Alexander) proposed an amendment to 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; as follows:

       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

[[Page 16522]]

     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.''.

  The PRESIDING OFFICER. The Senator from Ohio.

                          ____________________