
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document affected by Public Law 107-109 Section 18(a)]
[Document affected by Public Law 107-109 Section 19]
[Document affected by Public Law 107-109 Section 2]
[Document affected by Public Law 107-109 Section 4]
[Document affected by Public Law 107-109 Section 5(b)(2)]
[Document affected by Public Law 107-109 Section 7-11(a)]
[Document affected by Public Law 107-109 Section 7-11(a)]
[Document affected by Public Law 107-109 Section 11(b)]
[Document affected by Public Law 107-109 Section 16]
[Document affected by Public Law 107-109 Section 18(b)]
[CITE: 21USC355a]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 355a. Pediatric studies of drugs


(a) Market exclusivity for new drugs

    If, prior to approval of an application that is submitted under 
section 355(b)(1) of this title, the Secretary determines that 
information relating to the use of a new drug in the pediatric 
population may produce health benefits in that population, the Secretary 
makes a written request for pediatric studies (which shall 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) of this section or accepted in 
accordance with subsection (d)(3) of this section--
        (1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of 
    section 355 of this title, and in subsection (j)(4)(D)(ii) of such 
    section, is deemed to 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 such section to four years, to forty-eight months, 
    and to seven and one-half years are deemed to be four and one-half 
    years, fifty-four months, and eight years, respectively; or
        (ii) the period referred to in clauses (iii) and (iv) of 
    subsection (c)(3)(D) of such section, and in clauses (iii) and (iv) 
    of subsection (j)(4)(D) of such section, is deemed to be three years 
    and six months rather than three years; and
        (B) if the drug is designated under section 360bb of this title 
    for a rare disease or condition, the period referred to in section 
    360cc(a) of this title is deemed to be seven years and six months 
    rather than seven 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 355 of this title 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 subsections (b)(2)(A)(iii) or 
        (j)(2)(A)(vii)(III) of section 355 of this title,

    the period during which an application may not be approved under 
    section 355(c)(3) of this title or section 355(j)(4)(B) of this 
    title 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 355 of this title, 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 
    355(c)(3) of this title or section 355(j)(4)(B) of this title 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 November 21, 1997, the Secretary, 
after consultation with experts in pediatric research 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 to the holder of an 
approved application under section 355(b)(1) of this title for pediatric 
studies (which shall include a timeframe for completing such studies) 
concerning a drug identified in the list described in subsection (b) of 
this section, the holder agrees to the request, the studies are 
completed within any such timeframe, and the reports thereof are 
submitted in accordance with subsection (d)(2) of this section or 
accepted in accordance with subsection (d)(3) of this section--
        (1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of 
    section 355 of this title, and in subsection (j)(4)(D)(ii) of such 
    section, is deemed to 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 such section to four years, to forty-eight months, 
    and to seven and one-half years are deemed to be four and one-half 
    years, fifty-four months, and eight years, respectively; or
        (ii) the period referred to in clauses (iii) and (iv) of 
    subsection (c)(3)(D) of such section, and in clauses (iii) and (iv) 
    of subsection (j)(4)(D) of such section, is deemed to be three years 
    and six months rather than three years; and
        (B) if the drug is designated under section 360bb of this title 
    for a rare disease or condition, the period referred to in section 
    360cc(a) of this title is deemed to be seven years and six months 
    rather than seven 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 355 of this title 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 355 of this title,

    the period during which an application may not be approved under 
    section 355(c)(3) of this title or section 355(j)(4)(B) of this 
    title 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 355 of this title, 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 
    355(c)(3) of this title or section 355(j)(4)(B) of this title 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 from the 
    Secretary under subsection (a) or (c) of this section, after 
    consultation with--
            (A) the sponsor of an application for an investigational new 
        drug under section 355(i) of this title;
            (B) the sponsor of an application for a new drug under 
        section 355(b)(1) of this title; or
            (C) the holder of an approved application for a drug under 
        section 355(b)(1) of this title,

    agree with the sponsor or holder for the conduct of pediatric 
    studies for such drug. Such agreement shall be in writing and shall 
    include a timeframe for such studies.

        (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) of this section 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) of this section 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, 
    have been conducted in accordance with commonly accepted scientific 
    principles and protocols, and have been reported in accordance with 
    the requirements of the Secretary for filing.

(e) Delay of effective date for certain application

    If the Secretary determines that the acceptance or approval of an 
application under section 355(b)(2) or 355(j) of this title for a new 
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 the applicable period under clauses 
(ii) through (iv) of section 355(c)(3)(D) of this title or clauses (ii) 
through (iv) of section 355(j)(4)(D) of this title, but before the 
Secretary has determined whether the requirements of subsection (d) of 
this section have been satisfied, the Secretary shall delay the 
acceptance or approval under section 355(b)(2) or 355(j) of this title 
until the determination under subsection (d) of this section is made, 
but any such delay shall not exceed 90 days. In the event that 
requirements of this section are satisfied, the applicable six-month 
period under subsection (a) or (c) of this section 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) of this section have been met and that 
submissions and approvals under subsection (b)(2) or (j) of section 355 
of this title 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) Limitations

    A drug to which the six-month period under subsection (a) or (b) of 
this section has already been applied--
        (1) may receive an additional six-month period under subsection 
    (c)(1)(A)(ii) of this section for a supplemental application if all 
    other requirements under this section are satisfied, except that 
    such a drug may not receive any additional such period under 
    subsection (c)(2) of this section; and
        (2) may not receive any additional such period under subsection 
    (c)(1)(B) of this section.

(i) Relationship to regulations

    Notwithstanding any other provision of law, if any pediatric study 
is required pursuant to regulations promulgated by the Secretary and 
such study meets the completeness, timeliness, and other requirements of 
this section, such study shall be deemed to satisfy the requirement for 
market exclusivity pursuant to this section.

(j) Sunset

    A drug may not receive any six-month period under subsection (a) or 
(c) of this section unless the application for the drug under section 
355(b)(1) of this title is submitted on or before January 1, 2002. After 
January 1, 2002, a drug shall receive a six-month period under 
subsection (c) of this section if--
        (1) the drug was in commercial distribution as of November 21, 
    1997;
        (2) the drug was included by the Secretary on the list under 
    subsection (b) of this section as of January 1, 2002;
        (3) the Secretary determines that there is a continuing need for 
    information relating to the use of the drug in the pediatric 
    population and that the drug may provide health benefits in that 
    population; and
        (4) all requirements of this section are met.

(k) Report

    The Secretary shall conduct a study and report to Congress not later 
than January 1, 2001, based on the experience under the program 
established under this section. 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 on taxpayers and 
    consumers, including the impact of the lack of lower cost generic 
    drugs on patients, including on lower income patients; and
        (4) any suggestions for modification that the Secretary 
    determines to be appropriate.

(June 25, 1938, ch. 675, Sec. 505A, as added Pub. L. 105-115, title I, 
Sec. 111, Nov. 21, 1997, 111 Stat. 2305.)
