[Congressional Record Volume 143, Number 121 (Friday, September 12, 1997)]
[Senate]
[Pages S9298-S9299]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 THE FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT 
    OF 1997; PRESCRIPTION DRUG USERS FEE REAUTHORIZATION ACT OF 1997

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                       DeWINE AMENDMENT NO. 1136

  (Ordered to lie on the table.)
  Mr. DeWINE submitted an amendment intended to be proposed by him to 
the bill (S. 830) to amend the Federal Food, Drug, and Cosmetic Act and 
the Public Health Service Act to improve the regulation of food, drugs, 
devices, and biological products, and for other purposes; as follows:

       Strike section 618 and insert the following:

     SEC. 618. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

       (a) General Authority.--Chapter V of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
     inserting after section 505 the following:

     ``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

       ``(a) Market Exclusivity for New Drugs.--If, prior to 
     approval of an application that is submitted under subsection 
     (b)(1) or (j) of section 505, the Secretary determines that 
     information relating to the use of a drug in the pediatric 
     population may produce health benefits in that population, 
     the Secretary makes a written request for pediatric studies 
     (which may include a timeframe for completing such studies), 
     and such studies are completed within any such timeframe and 
     the reports thereof submitted in accordance with subsection 
     (d)(2) or completed within any such timeframe and the reports 
     thereof are accepted in accordance with subsection (d)(3)--
       ``(1)(A) the period during which an application may not be 
     submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) 
     of section 505 shall be five years and six months rather than 
     five years, and the references in subsections (c)(3)(D)(ii) 
     and (j)(4)(D)(ii) of section 505 to four years, to forty-
     eight months, and to seven and one-half years shall be deemed 
     to be four and one-half years, fifty-four months, and eight 
     years, respectively; or
       ``(B) the period of market exclusivity under subsections 
     (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
     section 505 shall be three years and six months rather than 
     three years; and
       ``(2)(A) if the drug is the subject of--
       ``(i) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(ii) or 
     (j)(2)(A)(vii)(II) of section 505 and for which pediatric 
     studies were submitted prior to the expiration of the patent 
     (including any patent extensions); or
       ``(ii) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(iii) or 
     (j)(2)(A)(vii)(III) of section 505,

     the period during which an application may not be approved 
     under subsection (c)(3) or (j)(4)(B) of section 505 shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(B)  if  the  drug  is  the  subject  of  a  listed   
     patent   for   which   a   certification has been submitted 
     under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
     section 505, and in the patent infringement litigation 
     resulting from the certification the court determines that 
     the patent is valid and would be infringed, the period during 
     which an application may not be approved under subsection 
     (c)(3) or (j)(4)(B) of section 505 shall be extended by a 
     period of six months after the date the patent expires 
     (including any patent extensions).
       ``(b) Secretary To Develop List of Drugs for Which 
     Additional Pediatric Information May Be Beneficial.--Not 
     later than 180 days after the date of enactment of this 
     section, the Secretary, after consultation with experts in 
     pediatric research (such as the American Academy of 
     Pediatrics, the Pediatric Pharmacology Research Unit Network, 
     and the United States Pharmacopoeia) shall develop, 
     prioritize, and publish an initial list of approved drugs for 
     which additional pediatric information may produce health 
     benefits in the pediatric population. The Secretary shall 
     annually update the list.
       ``(c) Market Exclusivity for Already-Marketed Drugs.--If 
     the Secretary makes a written request for pediatric studies 
     (which

[[Page S9299]]

     may include a timeframe for completing such studies) 
     concerning a drug identified in the list described in 
     subsection (b) to the holder of an approved application under 
     subsection (b)(1) or (j) of section 505 for the drug, the 
     holder agrees to the request, and the studies are completed 
     within any such timeframe and the reports thereof submitted 
     in accordance with subsection (d)(2) or completed within any 
     such timeframe and the reports thereof accepted in accordance 
     with subsection (d)(3)--
       ``(1)(A) the period during which an application may not be 
     submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) 
     of section 505 shall be five years and six months rather than 
     five years, and the references in subsections (c)(3)(D)(ii) 
     and (j)(4)(D)(ii) of section 505 to four years, to forty-
     eight months, and to seven and one-half years shall be deemed 
     to be four and one-half years, fifty-four months, and eight 
     years, respectively; or
       ``(B) the period of market exclusivity under subsections 
     (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
     section 505 shall be three years and six months rather than 
     three years; and
       ``(2)(A) if the drug is the subject of--
       ``(i) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(ii) or 
     (j)(2)(A)(vii)(II) of section 505 and for which pediatric 
     studies were submitted prior to the expiration of the patent 
     (including any patent extensions); or
       ``(ii) a listed patent for which a certification  has  been 
      submitted  under subsection (b)(2)(A)(iii) or 
     (j)(2)(A)(vii)(III) of section 505,

     the period during which an application may not be approved 
     under subsection (c)(3) or (j)(4)(B) of section 505 shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(B)  if  the  drug  is  the  subject  of  a  listed 
     patent   for   which   a   certification   has   been 
     submitted under subsection (b)(2)(A)(iv) or 
     (j)(2)(A)(vii)(IV) of section 505, and in the patent 
     infringement litigation resulting from the certification the 
     court determines that the patent is valid and would be 
     infringed, the period during which an application may not be 
     approved under subsection (c)(3) or (j)(4)(B) of section 505 
     shall be extended by a period of six months after the date 
     the patent expires (including any patent extensions).
       ``(d) Conduct of Pediatric Studies.--
       ``(1) Agreement for studies.--The Secretary may, pursuant 
     to a written request for studies, after consultation with--
       ``(A) the sponsor of an application for an investigational 
     new drug under section 505(i);
       ``(B) the sponsor of an application for a drug under 
     subsection (b)(1) or (j) of section 505; or
       ``(C) the holder of an approved application for a drug 
     under subsection (b)(1) or (j) of section 505,

     agree with the sponsor or holder for the conduct of pediatric 
     studies for such drug.
       ``(2) Written protocols to meet the studies requirement.--
     If the sponsor or holder and the Secretary agree upon written 
     protocols for the studies, the studies requirement of 
     subsection (a) or (c) is satisfied upon the completion of the 
     studies and submission of the reports thereof in accordance 
     with the original written request and the written agreement 
     referred to in paragraph (1). Not later than 60 days after 
     the submission of the report of the studies, the Secretary 
     shall determine if such studies were or were not conducted in 
     accordance with the original written request and the written 
     agreement and reported in accordance with the requirements of 
     the Secretary for filing and so notify the sponsor or holder.
       ``(3) Other methods to meet the studies requirement.--If 
     the sponsor or holder and the Secretary have not agreed in 
     writing on the protocols for the studies, the studies 
     requirement of subsection (a) or (c) is satisfied when such 
     studies have been completed and the reports accepted by the 
     Secretary. Not later than 90 days after the submission of the 
     reports of the studies, the Secretary shall accept or reject 
     such reports and so notify the sponsor or holder. The 
     Secretary's only responsibility in accepting or rejecting the 
     reports shall be to determine, within the 90 days, whether 
     the studies fairly respond to the written request, whether 
     such studies have been conducted in accordance with commonly 
     accepted scientific principles and protocols, and whether 
     such studies have been reported in accordance with the 
     requirements of the Secretary for filing.
       ``(e) Delay of Effective Date for Certain Applications; 
     Period of Market Exclusivity.--If the Secretary determines 
     that the acceptance or approval of an application under 
     subsection (b)(2) or (j) of section 505 for a drug may occur 
     after submission of reports of pediatric studies under this 
     section, which were submitted prior to the expiration of the 
     patent (including any patent extension) or market exclusivity 
     protection, but before the Secretary has determined whether 
     the requirements of subsection (d) have been satisfied, the 
     Secretary shall delay the acceptance or approval under 
     subsection (b)(2) or (j), respectively, of section 505 until 
     the determination under subsection (d) is made, but such 
     delay shall not exceed 90 days. In the event that 
     requirements of this section are satisfied, the applicable 
     period of market exclusivity referred to in subsection (a) or 
     (c) shall be deemed to have been running during the period of 
     delay.
       ``(f) Notice of Determinations on Studies Requirement.--The 
     Secretary shall publish a notice of any determination that 
     the requirements of subsection (d) have been met and that 
     submissions and approvals under subsection (b)(2) or (j) of 
     section 505 for a drug will be subject to the provisions of 
     this section.
       ``(g) Limitation.--The holder of an approved application 
     for a new drug that has already received six months of market 
     exclusivity under subsection (a) or (c) may, if otherwise 
     eligible, obtain six months of market exclusivity under 
     subsection (c)(1)(B) for a supplemental application, except 
     that the holder is not eligible for exclusivity under 
     subsection (c)(2).
       ``(h) Study and Report.--The Secretary shall conduct a 
     study and report to Congress not later than January 1, 2003 
     based on the experience under the program. The study and 
     report shall examine all relevant issues, including--
       ``(1) the effectiveness of the program in improving 
     information about important pediatric uses for approved 
     drugs;
       ``(2) the adequacy of the incentive provided under this 
     section;
       ``(3) the economic impact of the program; and
       ``(4) any suggestions for modification that the Secretary 
     deems appropriate.
       ``(i) Termination of Market Exclusivity Extension Authority 
     for New Drugs.--Except as provided in section 618(b) of the 
     Food and Drug Administration Modernization and Accountability 
     Act of 1997, no period of market exclusivity shall be 
     extended under subsection (a) for a drug if--
       ``(1) the extension would be based on studies commenced 
     after January 1, 2002; or
       ``(2) the application for the drug under subsection (b)(1) 
     or (j) of section 505 was not submitted by January 1, 2002.
       ``(j) Definitions.--In this section, the term `pediatric 
     studies' or `studies' means at least 1 clinical investigation 
     (that, at the Secretary's discretion, may include 
     pharmacokinetic studies) in pediatric age-groups in which a 
     drug is anticipated to be used.''.
       (b) Market Exclusivity Under Other Authority.--
       (1) Through calendar year 2003.--
       (A) Determination.--If the Secretary requests or requires 
     pediatric studies, prior to January 1, 2002, under Federal 
     law other than section 505A of the Federal Food, Drug, and 
     Cosmetic Act (as added by subsection (a)), from the sponsor 
     of an application, or the holder of an approved application, 
     for a drug under subsection (b) or (j) of section 505 of such 
     Act (21 U.S.C. 355), the Secretary shall determine whether 
     the studies meet the completeness, timeliness, and other 
     submission requirements of the Federal law involved.
       (B) Market exclusivity.--If the Secretary determines that 
     the studies meet the requirements involved, the Secretary 
     shall ensure that the period of market exclusivity for the 
     drug involved is extended for 6 months in accordance with the 
     requirements of subsection (a), (c), (e), and (g) (as 
     appropriate) of section 505A of such Act (as in effect on the 
     date of enactment of this Act.).
       (2) Calendar year 2002 and subsequent years.--
       (A) New drugs.--Effective January 1, 2002, if the Secretary 
     requests or requires pediatric studies, under Federal law 
     other than section 505A of the Federal Food, Drug, and 
     Cosmetic Act, from the sponsor of an application for a drug 
     under subsection (b) or (j) of section 505 of such Act, 
     nothing in such law shall be construed to permit or require 
     the Secretary to ensure that the period of market exclusivity 
     for the drug is extended.
       (B) Already marketed drugs.--
       (i) Determination.--Effective January 1, 2002, if the 
     Secretary requests or requires pediatric studies, under 
     Federal law other than section 505A of the Federal Food, 
     Drug, and Cosmetic Act (as added by subsection (a)), from the 
     holder of an approved application for a drug under subsection 
     (b) or (j) of section 505 of such Act (21 U.S.C. 355), the 
     Secretary shall determine whether the studies meet the 
     completeness, timeliness, and other submission requirements 
     of the Federal law involved.
       (ii) Market exclusivity.--If the Secretary determines that 
     the studies meet the requirements involved, the Secretary 
     shall ensure that the period of market exclusivity for the 
     drug involved is extended for 6 months in accordance with the 
     requirements of subsection (a), (c), (e), and (g) (as 
     appropriate) of section 505A of such Act (as in effect on the 
     date of enactment of this Act.).
       (3) Definitions.--In this subsection:
       (A) Drug.--The term ``drug'' has the meaning given the term 
     in section 201 of such Act.
       (B) Pediatric studies.--The term ``pediatric studies'' has 
     the meaning given the term in section 505A of such Act.
       (C) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.

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