[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 2178 Introduced in Senate (IS)]






104th CONGRESS
  2d Session
                                S. 2178

    To amend the Federal Food, Drug, and Cosmetic Act to allow for 
additional deferred effective dates for approval of applications under 
           the new drugs provisions, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 30, 1996

 Mrs. Kassebaum (for herself, Mr. Kennedy, Mr. Dodd, Mr. DeWine, Ms. 
        Mikulski, and Mr. Simon) introduced the following bill; which 
        was read twice and referred to the Committee on Labor and Human 
        Resources

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to allow for 
additional deferred effective dates for approval of applications under 
           the new drugs provisions, 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 ``Better Pharmaceuticals for Children 
Act''.

SEC. 2. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

    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 
new section:

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

    ``(a) Market Exclusivity for New Drugs.--If, prior to approval of 
an application that is submitted under section 505(b)(1) 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 time frame for completing such studies), and such studies are 
completed within any such time frame and the reports thereof submitted 
in accordance with subsection (d)(2) or completed within any such time 
frame 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 section 505(b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) 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 section 505(b)(2)(A)(iii) or 
                section 505(j)(2)(A)(vii)(III),
        the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) 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 section 
        505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), 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 section 505(c)(3) or section 505(j)(4)(B) 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 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 may 
include a time frame for completing such studies) concerning a drug 
identified in the list described in subsection (b) to the holder of an 
approved application under section 505(b)(1) for the drug, the holder 
agrees to the request, and the studies are completed within any such 
time frame and the reports thereof submitted in accordance with 
subsection (d)(2) or completed within any such time frame 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 section 
        505(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 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 section 
        505(b)(2)(A)(iii) or section 505(j)(2)(A)(vii)(III), the period 
        during which an application may not be approved under section 
        505(c)(3) or section 505(j)(4)(B) 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 section 
        505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), 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 section 505(c)(3) or section 505(j)(4)(B) 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 the 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 section 505(b)(1), or
                    ``(C) the holder of an approved application for a 
                drug under section 505(b)(1), 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 such 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 (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 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 section 505(b)(2) or 505(j) 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 section 505(b)(2) or 505(j), respectively, 
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 notice of any determination that the 
requirements of subsection (d) have been met and that submissions and 
approvals under section 505(b)(2) or (j) for a drug will be subject to 
the provisions of this section.
    ``(g) Definitions.--As used in this section, the term `pediatric 
studies' or `studies' means at least one 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.
    ``(h) Limitation.--The holder of an approved application for a new 
drug that has already received six months of market exclusivity under 
subsection (a) or subsection (c) may, if otherwise eligible, obtain six 
months of market exclusivity under subsection (c)(1)(B) for a 
supplemental application; however the holder is not eligible for 
exclusivity under subsection (c)(2).''
    ``(i) Sunset.--No period of market exclusivity shall be granted 
under this section based on studies commenced after January 1, 2004. 
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.''.
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