[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 4098 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 4098

To improve the process for the development of needed pediatric medical 
                                devices.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            December 6, 2006

 Mr. Dodd (for himself and Mr. DeWine) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To improve the process for the development of needed pediatric medical 
                                devices.

    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 ``Pediatric Medical Device Safety and 
Improvement Act of 2006''.

SEC. 2. TRACKING PEDIATRIC DEVICE APPROVALS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 515 the following:

``SEC. 515A. PEDIATRIC USES OF DEVICES.

    ``(a) New Devices.--
            ``(1) In general.--A person that submits to the Secretary 
        an application under section 520(m), or an application (or 
        supplement to an application) or a product development protocol 
        under section 515, shall include in the application or protocol 
        the information described in paragraph (2).
            ``(2) Required information.--The application or protocol 
        described in paragraph (1) shall include, with respect to the 
        device for which approval is sought and if readily available--
                    ``(A) a description of any pediatric subpopulations 
                that suffer from the disease or condition that the 
                device is intended to treat, diagnose, or cure; and
                    ``(B) the number of affected pediatric patients.
            ``(3) Annual report.--Not later than 18 months after the 
        date of enactment of this section, and annually thereafter, the 
        Secretary shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives a report that 
        includes--
                    ``(A) the number of devices approved in the year 
                preceding the year in which the report is submitted, 
                for which there is a pediatric subpopulation that 
                suffers from the disease or condition that the device 
                is intended to treat, diagnose, or cure;
                    ``(B) the number of devices approved in the year 
                preceding the year in which the report is submitted, 
                labeled for use in pediatric patients;
                    ``(C) the number of pediatric devices approved in 
                the year preceding the year in which the report is 
                submitted, exempted from a fee pursuant to section 
                738(a)(2)(B)(v); and
                    ``(D) the review time for each device described in 
                subparagraphs (A), (B), and (C).
    ``(b) Determination of Pediatric Effectiveness Based on Similar 
Course of Disease or Condition or Similar Effect of Device on Adults.--
            ``(1) In general.--If the course of the disease or 
        condition and the effects of the device are sufficiently 
        similar in adults and pediatric patients, the Secretary may 
        conclude that adult data may be used to support a determination 
        of a reasonable assurance of effectiveness in pediatric 
        populations, as appropriate.
            ``(2) Extrapolation between subpopulations.--A study may 
        not be needed in each pediatric subpopulation if data from one 
        subpopulation can be extrapolated to another subpopulation.''.

SEC. 3. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.

    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (3), by striking ``No'' and inserting 
        ``Except as provided in paragraph (6), no'';
            (2) in paragraph (5)--
                    (A) by inserting ``, if the Secretary has reason to 
                believe that the requirements of paragraph (6) are no 
                longer met,'' after ``public health''; and
                    (B) by adding at the end the following: ``If the 
                person granted an exemption under paragraph (2) fails 
                to demonstrate continued compliance with the 
                requirements of this subsection, the Secretary may 
                suspend or withdraw the exemption from the 
                effectiveness requirements of sections 514 and 515 for 
                a humanitarian device only after providing notice and 
                an opportunity for an informal hearing.'';
            (3) by striking paragraph (6) and inserting the following:
    ``(6)(A) Except as provided in subparagraph (D), the prohibition in 
paragraph (3) shall not apply with respect to a person granted an 
exemption under paragraph (2) if each of the following conditions 
apply:
            ``(i)(I) The device with respect to which the exemption is 
        granted is intended for the treatment or diagnosis of a disease 
        or condition that occurs in pediatric patients or in a 
        pediatric subpopulation, and such device is labeled for use in 
        pediatric patients or in a pediatric subpopulation in which the 
        disease or condition occurs.
            ``(II) The device was not previously approved under this 
        subsection for the pediatric patients or the pediatric 
        subpopulation described in subclause (I) prior to the date of 
        enactment of the Pediatric Medical Device Safety and 
        Improvement Act of 2006.
            ``(ii) During any calendar year, the number of such devices 
        distributed during that year does not exceed the annual 
        distribution number specified by the Secretary when the 
        Secretary grants such exemption. The annual distribution number 
        shall be based on the number of individuals affected by the 
        disease or condition that such device is intended to treat, 
        diagnose, or cure, and of that number, the number of 
        individuals likely to use the device, and the number of devices 
        reasonably necessary to treat such individuals. In no case 
        shall the annual distribution number exceed the number 
        identified in paragraph (2)(A).
            ``(iii) Such person immediately notifies the Secretary if 
        the number of such devices distributed during any calendar year 
        exceeds the annual distribution number referred to in clause 
        (ii).
            ``(iv) The request for such exemption is submitted on or 
        before October 1, 2012.
    ``(B) The Secretary may inspect the records relating to the number 
of devices distributed during any calendar year of a person granted an 
exemption under paragraph (2) for which the prohibition in paragraph 
(3) does not apply.
    ``(C) A person may petition the Secretary to modify the annual 
distribution number specified by the Secretary under subparagraph 
(A)(ii) with respect to a device if additional information on the 
number of individuals affected by the disease or condition arises, and 
the Secretary may modify such number but in no case shall the annual 
distribution number exceed the number identified in paragraph (2)(A).
    ``(D) If a person notifies the Secretary, or the Secretary 
determines through an inspection under subparagraph (B), that the 
number of devices distributed during any calendar year exceeds the 
annual distribution number, as required under subparagraph (A)(iii), 
and modified under subparagraph (C), if applicable, then the 
prohibition in paragraph (3) shall apply with respect to such person 
for such device for any sales of such device after such notification.
    ``(E)(i) In this subsection, the term `pediatric patients' means 
patients who are 21 years of age or younger at the time of the 
diagnosis or treatment.
    ``(ii) In this subsection, the term `pediatric subpopulation' means 
1 of the following populations:
            ``(I) Neonates.
            ``(II) Infants.
            ``(III) Children.
            ``(IV) Adolescents.''; and
            (4) by adding at the end the following:
    ``(7) The Secretary shall refer any report of an adverse event 
regarding a device for which the prohibition under paragraph (3) does 
not apply pursuant to paragraph (6)(A) that the Secretary receives to 
the Office of Pediatric Therapeutics, established under section 6 of 
the Best Pharmaceuticals for Children Act (Public Law 107-109)). In 
considering the report, the Director of the Office of Pediatric 
Therapeutics, in consultation with experts in the Center for Devices 
and Radiological Health, shall provide for periodic review of the 
report by the Pediatric Advisory Committee, including obtaining any 
recommendations of such committee regarding whether the Secretary 
should take action under this Act in response to the report.''.
    (b) Report.--Not later than January 1, 2011, the Comptroller 
General of the United States shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report on the 
impact of allowing persons granted an exemption under section 520(m)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with 
respect to a device to profit from such device pursuant to section 
520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amended by subsection 
(a)), including--
            (1) an assessment of whether such section 520(m)(6) (as 
        amended by subsection (a)) has increased the availability of 
        pediatric devices for conditions that occur in small numbers of 
        children, including any increase or decrease in the number of--
                    (A) exemptions granted under such section 520(m)(2) 
                for pediatric devices; and
                    (B) applications approved under section 515 of such 
                Act (21 U.S.C. 360e) for devices intended to treat, 
                diagnose, or cure conditions that occur in pediatric 
                patients or for devices labeled for use in a pediatric 
                population;
            (2) the conditions or diseases the pediatric devices were 
        intended to treat or diagnose and the estimated size of the 
        pediatric patient population for each condition or disease;
            (3) the costs of the pediatric devices, based on a survey 
        of children's hospitals;
            (4) the extent to which the costs of such devices are 
        covered by health insurance;
            (5) the impact, if any, of allowing profit on access to 
        such devices for patients;
            (6) the profits made by manufacturers for each device that 
        receives an exemption;
            (7) an estimate of the extent of the use of the pediatric 
        devices by both adults and pediatric populations for a 
        condition or disease other than the condition or disease on the 
        label of such devices;
            (8) recommendations of the Comptroller General of the 
        United States regarding the effectiveness of such section 
        520(m)(6) (as amended by subsection (a)) and whether any 
        modifications to such section 520(m)(6) (as amended by 
        subsection (a)) should be made;
            (9) existing obstacles to pediatric device development; and
            (10) an evaluation of the demonstration grants described in 
        section 5.
    (c) Guidance.--Not later than 180 days after the date of enactment 
of this Act, the Commissioner of Food and Drugs shall issue guidance 
for institutional review committees on how to evaluate requests for 
approval for devices for which a humanitarian device exemption under 
section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j(m)(2)) has been granted.

SEC. 4. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.

    (a) Access to Funding.--The Director of the National Institutes of 
Health shall designate a contact point or office at the National 
Institutes of Health to help innovators and physicians access funding 
for pediatric medical device development.
    (b) Plan for Pediatric Medical Device Research.--
            (1) In general.--Not later than 180 days after the date of 
        enactment of this Act, the Commissioner of Food and Drugs, in 
        collaboration with the Director of the National Institutes of 
        Health and the Director of the Agency for Healthcare Research 
        and Quality, shall submit to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives a plan 
        for expanding pediatric medical device research and 
        development. In developing such plan, the Commissioner of Food 
        and Drugs shall consult with individuals and organizations with 
        appropriate expertise in pediatric medical devices.
            (2) Contents.--The plan under paragraph (1) shall include--
                    (A) the current status of federally funded 
                pediatric medical device research;
                    (B) any gaps in such research, which may include a 
                survey of pediatric medical providers regarding unmet 
                pediatric medical device needs, as needed; and
                    (C) a research agenda for improving pediatric 
                medical device development and Food and Drug 
                Administration clearance or approval of pediatric 
                medical devices, and for evaluating the short- and 
                long-term safety and effectiveness of pediatric medical 
                devices.

SEC. 5. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE 
              AVAILABILITY.

    (a) In General.--
            (1) Request for proposals.--Not later than 90 days after 
        the date of enactment of this Act, the Secretary of Health and 
        Human Services shall issue a request for proposals for 1 or 
        more grants or contracts to nonprofit consortia for 
        demonstration projects to promote pediatric device development.
            (2) Determination on grants or contracts.--Not later than 
        180 days after the date the Secretary of Health and Human 
        Services issues a request for proposals under paragraph (1), 
        the Secretary shall make a determination on the grants or 
        contracts under this section.
    (b) Application.--A nonprofit consortium that desires to receive a 
grant or contract under this section shall submit an application to the 
Secretary of Health and Human Services at such time, in such manner, 
and containing such information as the Secretary may require.
    (c) Use of Funds.--A nonprofit consortium that receives a grant or 
contract under this section shall--
            (1) encourage innovation by connecting qualified 
        individuals with pediatric device ideas with potential 
        manufacturers;
            (2) mentor and manage pediatric device projects through the 
        development process, including product identification, 
        prototype design, device development, and marketing;
            (3) connect innovators and physicians to existing Federal 
        resources, including resources from the Food and Drug 
        Administration, the National Institutes of Health, the Small 
        Business Administration, the Department of Energy, the 
        Department of Education, the National Science Foundation, the 
        Department of Veterans Affairs, the Agency for Healthcare 
        Research and Quality, and the National Institute of Standards 
        and Technology;
            (4) assess the scientific and medical merit of proposed 
        pediatric device projects;
            (5) assess business feasibility and provide business 
        advice;
            (6) provide assistance with prototype development; and
            (7) provide assistance with postmarket needs, including 
        training, logistics, and reporting.
    (d) Coordination.--
            (1) National institutes of health.--Each consortium that 
        receives a grant or contract under this section shall--
                    (A) coordinate with the National Institutes of 
                Health's pediatric device contact point or office, 
                designated under section 4; and
                    (B) provide to the National Institutes of Health 
                any identified pediatric device needs that the 
                consortium lacks sufficient capacity to address or 
                those needs in which the consortium has been unable to 
                stimulate manufacturer interest.
            (2) Food and drug administration.--Each consortium that 
        receives a grant or contract under this section shall 
        coordinate with the Commissioner of Food and Drugs and device 
        companies to facilitate the application for approval or 
        clearance of devices labeled for pediatric use.
    (e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $6,000,000 for each of fiscal 
years 2007 through 2011.

SEC. 6. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC 
              ADVISORY COMMITTEE.

    (a) Office of Pediatric Therapeutics.--Section 6(b) of the Best 
Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is amended by 
inserting ``, including increasing pediatric access to medical 
devices'' after ``pediatric issues''.
    (b) Pediatric Advisory Committee.--Section 14 of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended--
            (1) in subsection (a), by inserting ``(including drugs and 
        biological products) and medical devices'' after 
        ``therapeutics''; and
            (2) in subsection (b)--
                    (A) in paragraph (1), by inserting ``(including 
                drugs and biological products) and medical devices'' 
                after ``therapeutics''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``and 
                        505B'' and inserting ``505B, 510(k), 515, and 
                        520(m)'';
                            (ii) by striking subparagraph (B) and 
                        inserting the following:
                    ``(B) identification of research priorities related 
                to therapeutics (including drugs and biological 
                products) and medical devices for pediatric populations 
                and the need for additional diagnostics and treatments 
                for specific pediatric diseases or conditions; and''; 
                and
                            (iii) in subparagraph (C), by inserting 
                        ``(including drugs and biological products) and 
                        medical devices'' after ``therapeutics''.

SEC. 7. STUDIES.

    (a) Postmarket Studies.--Section 522 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360l) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``, or as a condition to approval 
                of an application (or a supplement to an application) 
                or a product development protocol under section 515 or 
                as a condition to clearance of a premarket notification 
                report under section 510(k),'' after ``The Secretary 
                may by order''; and
                    (B) by inserting ``, that is expected to have 
                significant use in pediatric populations,'' after 
                ``health consequences''; and
            (2) in subsection (b)--
                    (A) by striking ``(b) Surveillance Approval.--
                Each'' and inserting the following:
    ``(b) Surveillance Approval.--
            ``(1) In general.--Each'';
                    (B) by striking ``The Secretary, in consultation'' 
                and inserting ``Except as provided in paragraph (2), 
                the Secretary, in consultation'';
                    (C) by striking ``Any determination'' and inserting 
                ``Except as provided in paragraph (2), any 
                determination''; and
                    (D) by adding at the end the following:
            ``(2) Longer studies for pediatric devices.--The Secretary 
        may by order require a prospective surveillance period of more 
        than 36 months with respect to a device that is expected to 
        have significant use in pediatric populations if such period of 
        more than 36 months is necessary in order to assess the impact 
        of the device on growth and development, or the effects of 
        growth, development, activity level, or other factors on the 
        safety or efficacy of the device.''.
    (b) Database.--
            (1) In general.--
                    (A) Establishment.--The Secretary of Health and 
                Human Services, acting through the Commissioner of Food 
                and Drugs, shall establish a publicly accessible 
                database of studies of medical devices that includes 
                all studies and surveillances, described in paragraph 
                (2)(A), that were in progress on the date of enactment 
                of this Act or that began after such date.
                    (B) Accessibility.--Information included in the 
                database under subparagraph (A) shall be in language 
                reasonably accessible and understood by individuals 
                without specific expertise in the medical field.
            (2) Studies and surveillances.--
                    (A) Included.--The database described in paragraph 
                (1) shall include--
                            (i) all postmarket surveillances ordered 
                        under section 522(a) of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 360l(a)) or agreed 
                        to by the manufacturer; and
                            (ii) all other studies completed by the 
                        manufacturer with respect to a medical device 
                        after--
                                    (I) the premarket approval of such 
                                device under section 515 of the Federal 
                                Food, Drug, and Cosmetic Act (21 U.S.C. 
                                360e);
                                    (II) the clearance of a premarket 
                                notification report under section 
                                510(k) of such Act (21 U.S.C. 360(k)) 
                                with respect to such device; or
                                    (III) submission of an application 
                                under section 520(m) of such Act (21 
                                U.S.C. 360j(m)) with respect to such 
                                device.
                    (B) Excluded.--The database described in paragraph 
                (1) shall not include any studies with respect to a 
                medical device that were completed prior to the initial 
                approval of such device.
            (3) Contents of study and surveillance.--For each study or 
        surveillance included in the database described in paragraph 
        (1), the database shall include--
                    (A) information on the status of the study or 
                surveillance;
                    (B) basic information about the study or 
                surveillance, including the purpose, the primary and 
                secondary outcomes, and the population targeted;
                    (C) the expected completion date of the study or 
                surveillance;
                    (D) public health notifications, including safety 
                alerts; and
                    (E) any other information the Secretary of Health 
                and Human Services determines appropriate to protect 
                the public health.
            (4) Once completed or terminated.--In addition to the 
        information described in paragraph (3), once a study or 
        surveillance has been completed or if a study or surveillance 
        is terminated, the database shall also include--
                    (A) the actual date of completion or termination;
                    (B) if the study or surveillance was terminated, 
                the reason for termination;
                    (C) if the study or surveillance was submitted but 
                not accepted by the Food and Drug Administration 
                because the study or surveillance did not meet the 
                requirements for such study or surveillance, an 
                explanation of the reasons and any follow-up action 
                required;
                    (D) information about any labeling changes made to 
                the device as a result of the study or surveillance 
                findings;
                    (E) information about any other decisions or 
                actions of the Food and Drug Administration that result 
                from the study or surveillance findings;
                    (F) lay and technical summaries of the study or 
                surveillance results and key findings, or an 
                explanation as to why the results and key findings do 
                not warrant public availability;
                    (G) a link to any peer reviewed articles on the 
                study or surveillance; and
                    (H) any other information the Secretary of Health 
                and Human Services determines appropriate to protect 
                the public health.
            (5) Public access.--The database described in paragraph (1) 
        shall be--
                    (A) accessible to the general public; and
                    (B) easily searchable by multiple criteria, 
                including whether the study or surveillance involves 
                pediatric populations.
    (c) Medical Device Coding.--The Secretary of Health and Human 
Services, in consultation with the Commissioner of Food and Drugs, 
shall adopt voluntary national standards for medical device coding. In 
adopting voluntary national standards for medical device coding, the 
Secretary of Health and Human Services shall coordinate with other 
efforts by the Secretary to adopt and implement standards for the 
electronic exchange of health information.
                                 <all>