[Congressional Record Volume 152, Number 133 (Wednesday, December 6, 2006)]
[Senate]
[Pages S11343-S11348]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DODD (for himself and Mr. DeWine):
  S. 4098. A bill to improve the process for the development of needed 
pediatric medical devices; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. DODD. Mr. President, I rise today to introduce the Pediatric 
Medical Device Safety and Improvement Act of 2006. I want to begin by 
thanking Senator Mike DeWine for joining me in introducing this 
legislation and for his leadership on children's health. He has been my 
partner over the years as we fought to make drugs safer and more widely 
available for children. I believe the legislation we are introducing 
today will achieve a similar goal for pediatric medical devices. I 
would also like to especially thank the Elizabeth Glaser Pediatric AIDS 
Foundation, the American Academy of Pediatrics, the American Thoracic 
Society and the National Organization for Rare Disorders for their 
expertise in helping craft this legislation as well as their tireless 
support for making medical devices safer for use in children.
  This legislation provides a comprehensive approach to ensuring that 
children are not left behind as cutting-edge research and revolutionary 
technologies for medical devices advance. Like drugs, where for too 
long children were treated like small adults and could just be given 
reduced doses of adult products, many essential medical devices used 
extensively by pediatricians are not designed or sized for children. In 
fact, the development of new medical devices suitable for children's 
smaller and growing bodies can lag 5 or 10 years behind those for 
adults.
  While children and adults suffer from many of the same diseases and 
conditions, their device needs can vary considerably due to differences 
in size, rates of growth, critical development periods, anatomy, 
physiological differences such as breathing and heart rate, and 
physical activity levels. To date, because the pediatric market is so 
small and pediatric diseases relatively rare, there has been little 
incentive for device manufacturers to focus their attention on 
children. The result has been that pediatric providers must resort to 
``jerry-rigging'' or fashioning make-shift device solutions for 
pediatric use. When that is not an option, providers may be forced to 
use more invasive treatment or less effective therapies.
  For example, at present, left ventricular assist devices, LVADs, do 
not exist in the U.S. for children less than 5 years old. An LVAD is a 
mechanical pump that helps a heart that is too weak to pump blood 
through the body.

[[Page S11344]]

So infants and children under 5 years of age who have critical failure 
of their left or right ventricles have to be supported through 
extracorporeal membrane oxygenation, ECMO. An ECMO consists of a pump, 
an artificial lung, a blood warmer and an arterial filter, which is 
installed by inserting tubes into large veins or arteries located in 
the right side of the neck or the groin. While ECMOs can help children 
for short periods of time, they are problematic. They can cause 
dangerous clots and the blood thinners that prevent these clots may 
lead to internal bleeding. In addition, children must remain bedridden 
while using the device.
  For young children needing to be on a ventilator to assist their 
breathing, the lack of non-invasive ventilators with masks that 
suitably fit babies has led to respiratory treatments that are 
inadequate or invasive treatment options such as placing a tube in the 
baby's throat.
  Children needing prosthetic heart valves face a disproportionately 
high failure rate. Because of the biochemistry of children's growing 
bodies, prosthetic heart valves implanted in children calcify and 
deteriorate much faster than in adults. Typically, children with a 
heart valve implant who survive to adulthood will need four or five 
operations. Additionally, devices currently available for children must 
be better able to expand and grow as the child grows.
  Over the past 2 years, several efforts have been launched to better 
identify barriers to the development of pediatric devices and to 
generate solutions for improving children's access to needed medical 
devices.
  Beginning in June 2004, the American Academy of Pediatrics, the 
Elizabeth Glaser Pediatric AIDS Foundation, the National Organization 
for Rare Disorders, NORD, the National Association of Children's 
Hospitals, and the Advanced Medical Technology Association, AdvaMed, 
hosted a series of stakeholders meetings that yielded recommendations 
for improving the availability of pediatric devices. In October 2004, 
in response to a directive in the Medical Devices Technical Corrections 
Act of 2004, the Food and Drug Administration, FDA, released a report 
that identified numerous barriers to the development and approval of 
devices for children. And in July 2005, the Institute of Medicine, IOM, 
issued a report on the adequacy of postmarket surveillance of pediatric 
medical devices, as mandated by the Medical Device User Fee and 
Modernization Act of 2002. The IOM found significant flaws in safety 
monitoring and recommended expanding the FDA's ability to require 
postmarket studies of certain products and improving public access to 
information about postmarket pediatric studies.
  Our legislation seeks to address the equally important issues of 
pediatric medical device safety and availability. To begin with, the 
bill creates a mechanism to allow the FDA to track the number and types 
of medical devices approved specifically for children or for conditions 
that occur in children. It also allows the FDA to use adult data to 
support a determination of reasonable assurance of effectiveness in 
pediatric populations and to extrapolate data between pediatric 
subpopulations.
  The market for pediatric medical devices simply isn't what it is for 
adults. Therefore, many device manufacturers have been reluctant to 
make devices for children. Our bill creates an incentive for companies 
by modifying the existing humanitarian device exemption, HDE, provision 
to allow manufacturers to profit from devices that are specifically 
designed to meet a pediatric need.
  To prevent abuse, our bill reverts to current law which allows no 
profit on sales of devices that exceed the number estimated to be 
needed for the approved condition. This provision is modeled after the 
existing Orphan Products Division designation process. Under no 
circumstances can there be a profit on sales if the device is used to 
treat or diagnose diseases or conditions affecting more than 4,000 
individuals in the U.S. per year which is the same as under current 
law. Already approved adult HDEs upon date of enactment are eligible 
for the HDE profit modification but only if they are meet the 
conditions of the bill. The lifting of the profit restriction for new 
pediatric HDEs sunsets in 2012 and FDA is required to issue a report on 
its impact within 5 years.
  In order to encourage pediatric medical device research, our bill 
requires the National Institutes of Health, NIH, to designate a point 
of contact at the agency to help innovators and physicians access 
funding for pediatric medical device development. It also requires the 
NIH, the FDA, and the Agency for Healthcare Research and Quality, AHRQ, 
to submit a plan for pediatric medical device research that identifies 
gaps in such research and proposes a research agenda for addressing 
them. In identifying the gaps, the plan can include a survey of 
pediatric medical providers regarding unmet pediatric medical device 
needs.
  To better foster innovation in the private sector, our bill 
establishes demonstration grants for non-profit consortia to promote 
pediatric device development, including matchmaking between inventors 
and manufacturers and federal resources. These demonstration grants 
which are authorized for $6 million annually require that the federal 
government mentor and help manage pediatric device projects through the 
development process, including product identification, prototype 
design, device development and marketing. Under the bill, grantees must 
coordinate with the NIH's pediatric devices point of contact to 
identify research issues that require further study and with the FDA to 
help facilitate approval of pediatric indications.
  Finally, in its 2005 report on pediatric medical device safety, the 
IOM found serious flaws in the postmarket safety surveillance of these 
devices. Our legislation allows FDA to require postmarket studies as a 
condition of clearance for certain categories of devices. This includes 
``a class II or class III device the failure of which would be 
reasonably likely to have serious adverse health consequences or is 
intended to be (1) implanted in the human body for more than one year, 
or (2) a life sustaining or life supporting device used outside a 
device user facility.''
  The legislation also gives the FDA the ability to require studies 
longer than 3 years with respect to a device that is to have 
significant use in pediatric populations if such studies would be 
necessary to address longer term pediatric questions, such as the 
impact on growth and development. And, it establishes a publicly 
accessible database of postmarket study commitments that involve 
questions about device use in pediatric populations.
  The legislation we are introducing today has been many years in the 
making. In addition to the lead republican bill sponsor, Senator 
DeWine, and the public health organizations I mentioned earlier, I 
would like to thank the Advanced Medical Technology Association and its 
member company Johnson & Johnson, for their contributions to this 
legislation. The bill we are introducing today reflects many of the 
comments and suggestions they provided through the development of this 
legislation. Several device manufacturers including Respironics, 
Seleon, Breas Medical AB, and Stryker have submitted letters of support 
for this legislation and I ask unanimous consent that their letters as 
well as the letters of all organizations supporting this bill be 
entered in the record following my remarks.
  I look forward to working with patient groups, physicians, industry 
and my colleagues--including the chairman and ranking member of the 
Health, Education, Labor and Pensions Committee, Senators Enzi and 
Kennedy--to move this legislation next year when the committee 
considers medical device legislation. I urge my colleagues to support 
this legislation and I am hopeful that it will become law as soon as 
possible.
  I ask unanimous consent that the letters and the text of the bill be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                  Elizabeth Glaser


                                    Pediatric AIDS Foundation,

                                 Washington, DC, December 5, 2006.

     Hon. Christopher Dodd,
     Russell Senate Office Building,
     Washington, DC.

     Hon. Mike DeWine,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senators Dodd and DeWine: On behalf of the Elizabeth 
     Glaser Pediatric AIDS

[[Page S11345]]

     Foundation, I would like to express our strong support for 
     the Pediatric Medical Device Safety and Improvement Act of 
     2006. Your leadership on this issue has been outstanding and 
     I applaud your efforts to introduce legislation that will 
     improve the health and well-being of children across the U.S.
       While cutting-edge research and revolutionary technologies 
     have led to the development of countless innovative medical 
     devices, as science and medicine move forward children are at 
     risk of being left behind. Physical differences such as 
     children's size, anatomy, and growth provide challenges that 
     limit children's access to safe and effective medical 
     devices. With very few devices available for pediatric use, 
     pediatric providers must resort to ``jury-rigging'' or 
     fashioning make-shift device solutions for their patients. 
     When that is not an option, providers may be forced to use 
     more invasive treatment or less effective therapies.
       This legislation recognizes the urgent need for improved 
     access to medical devices designed specifically for children 
     and provides a comprehensive approach to addressing this 
     issue that includes providing assistance to innovators, 
     streamlining regulatory processes, elevating pediatric device 
     issues at the FDA and NIH, and improving incentives for 
     devices for small markets--while still preserving the ability 
     to ensure the safety of new products.
       Thank you for your leadership and commitment to this issue. 
     We look forward to working closely with you to ensure that 
     children across the U.S. benefit from this important piece of 
     legislation.
           Sincerely,
                                                 Pamela W. Barnes,
     President and Chief Executive Officer.
                                  ____



                                    American Thoracic Society,

                                 New York, NY, September 11, 2006.

     Hon. Mike DeWine,
     U.S. Senate,
     Washington, DC.
       Dear Senator DeWine: On behalf of the American Thoracic 
     Society, I want to encourage you to continue your efforts to 
     improve access to medical devices for children by introducing 
     legislation this fall.
       The ATS represents over 13,000 physicians, researchers, and 
     allied health professionals, who are actively engaged in the 
     diagnosis, treatment and research of respiratory disease and 
     critical care medicine. Many of the patients we treat are 
     children suffering from respiratory diseases.
       You have long been a champion of the health needs of 
     children and you are well aware that children are not 
     ``little people.'' Children have specific health needs and 
     challenges. This is particularly true in the case of medical 
     equipment.
       The medical device industry has excelled in developing new 
     products that improve the care and well being for patients 
     with respiratory diseases. However, due to the reduced market 
     size, many of these breakthrough respiratory devices are not 
     available to children. Children do not have the same access 
     to ventilators, sleep apnea machines, masks and other 
     respiratory related equipment that adults enjoy. The device 
     access issue for children is a persistent problem in other 
     fields of medicine.
       The research and regulatory requirements for making 
     pediatric specific devices can be daunting and may outweigh 
     the business potential for entering the pediatric device 
     market.
       We have worked with our colleagues at the American Academy 
     of Pediatrics and members of your staff to develop a 
     legislative proposal that would remove many of the barriers 
     that exist to binging pediatric specific medical devices 
     products to the market. We strongly encourage you to 
     introduce this legislation this fall.
       The American Thoracic Society looks forward to working with 
     you to bring this legislative proposal to fruition.
           Sincerely,
                                                  John E. Heffner,
     President.
                                  ____



                               American Academy of Pediatrics,

                          Elk Grove Village, IL, December 4, 2006.
     Hon. Christopher J. Dodd,
     U.S. Senate, Washington, DC.
     Hon. Mike DeWine,
     U.S. Senate, Washington, DC.
       Dear Senators Dodd and DeWine: On behalf of the 60,000 
     primary care pediatricians, pediatric medical subspecialists, 
     and surgical specialists of the American Academy of 
     Pediatrics who are committed to the attainment of optimal 
     physical, mental and social health and well-being for all 
     infants, children, adolescents, and young adults, we write 
     today to express our gratitude and support for the 
     ``Pediatric Medical Device Safety and Improvement Act of 
     2006.'' This legislation is an important step towards 
     improving the process for the development of needed pediatric 
     medical devices.
       Children and adults often suffer from many of the same 
     diseases and conditions, however their medical device needs 
     vary considerable. Children are not just small adults and 
     medical device technologies manufactured for adults often do 
     not fit the needs of children. This problems forces 
     pediatricians to ``jury-rig'' adult medical devices that are 
     often too large in order to make them fit smaller bodies. 
     This practice, however, is not always effective and leaves 
     children without optimal treatment. Additionally, children's 
     device needs vary considerable, due not only to size, but 
     also to different rates of growth, anatomy, physiological 
     differences and physical activity levels.
       This legislation offers incentives to manufacturers to 
     create needed medical devices specifically designed to meet 
     the needs of pediatric patients and it gives the Food and 
     Drug Administration the authority to require post-market 
     studies to ensure continued efficacy and safety of these 
     devices. The need for pediatric medical devices to treat or 
     diagnose diseases and conditions affecting children is clear. 
     Hence, it is essential that medical devices be manufactured 
     with children's needs in mind.
       Thank you for your continued commitment to improving the 
     health and well-being of children. The American Academy of 
     Pediatrics looks forward to working with you as this 
     important legislation moves through Congress.
           Sincerely,
     American Academy of Pediatrics.
     The American Pediatric Society.
     The Association of Medical School Pediatric Department 
     Chairs.
     The Society for Pediatric Research.
                                  ____

                                 Murrysville, PA, August 16, 2006.
     Hon. Mike DeWine,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senator DeWine, Respironics, Inc. is a global medical 
     device company based in Pittsburgh, Pennsylvania. We are the 
     worldwide leader at anticipating needs and providing valued 
     solutions to the sleep and respiratory markets. We employ 
     approximately 4,700 employees and have annual sales in excess 
     of one billion dollars.
       In our business, we often are called upon to work with 
     pediatric patients. Based on this work, it is clear that 
     changes are needed to facilitate an improvement in the 
     availability of diagnostic and therapeutic medical devices 
     for children.
       Currently, a draft of a bill entitled ``To improve the 
     process for the development of needed pediatric medical 
     devices'' is being circulated among some Senators for 
     discussion. After reviewing this bill, Respironics believes 
     that the changes contemplated by this bill could help improve 
     the availability of medical devices for children. Therefore, 
     Respironics supports enactment of the bill.
       We hope that you will join Respironics in supporting this 
     important legislation.
           Sincerely,
                                                   David P. White,
     Chief Medical Officer.
                                  ____



                                                 Seleon, Inc.,

                                Baltimore, MD, September 23, 2006.
     Hon. Mike DeWine,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senator DeWine: On behalf of Seleon Inc., I want to 
     encourage you to continue your efforts to improve access to 
     medical therapies for children by introducing the bill, ``to 
     improve the process for the development of needed pediatric 
     medical devices'' this fall.
       Seleon Inc., a medical device manufacturing company, 
     strongly supports this bill. Thank you for your ongoing 
     support of children's health and this important issue.
           Sincerely,
                                                     Michael Lauk,
     President.
                                  ____



                                             Breas Medical AB,

                               Molnlycke, Sweden, August 17, 2006.
     Hon. Christopher J. Dodd,
     Hon. Mike DeWine,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senators Dodd and DeWine, On behalf of Breas Medical, 
     I would like to thank you for your efforts to expand the 
     availability of medical devices for children. We appreciate 
     your long-standing leadership on behalf of children and 
     welcome your interest in ensuring that they are not left 
     behind when it comes to critical medical advances. Our 
     devices were developed in Europe and are available for home 
     use in the pediatric population there. We have partnered with 
     companies in the United States, including Sleep Services of 
     America, and now have FDA approval for device use in adults. 
     We are seeking approval for the use of our devices in 
     children where there is a great need.
       While children and adults suffer from many of the same 
     diseases and conditions, their device needs can vary 
     considerably. Cutting-edge research and revolutionary 
     technologies have led to the development of many innovative 
     medical products; however, very few are designed specifically 
     for children. We support your efforts to address the barriers 
     to pediatric device development through legislation, 
     particularly in the following areas:
       1. Improving the ability of the Food and Drug 
     Administration (FDA) to track how many and what types of 
     devices are approved for children each year;
       2. Streamlining pediatric device approvals by allowing the 
     extrapolation of adult data to support pediatric indications, 
     as appropriate;
       3. Encouraging device manufacturers to create products for 
     conditions that affect small numbers of children by removing 
     existing restrictions on profit;
       4. Improving federal support for pediatric device 
     development by creating a coordinated research agenda and 
     establishing a

[[Page S11346]]

     contact point at the National Institutes of Health to help 
     innovators access existing funding;
       5. Improving pediatric device availability by establishing 
     demonstration grants to promote pediatric device development, 
     including connecting inventors and manufacturers, product 
     identification, prototype development, and testing;
       6. Improving post-market safety of pediatric devices by 
     allowing FDA to call for postmarket pediatric studies, 
     establishing a publicly accessible database of postmarket 
     studies, and giving FDA the ability to require studies longer 
     than 3 years if needed to answer longer-term pediatric 
     questions.
       Thank you for your leadership and commitment to this issue. 
     We look forward to working closely with you toward passage of 
     legislation to improve children's access to medical devices.
           Sincerely,
                                                      Ulf Jonsson,
     President.
                                  ____



                                          Stryker Corporation,

                                 Washington, DC, December 4, 2006.
     Senator Christopher J. Dodd,
     Russell Senate Office Building, Washington, DC.
       Dear Senator Dodd: On behalf of Stryker Corporation 
     (``Stryker''), I am pleased to announce our support for your 
     legislation to improve the availability and safety of 
     pediatric medical devices--the Pediatric Medical Device 
     Safety and Improvement Act of 2006. Like you and your 
     colleagues, we want our children to have access to the 
     fullest and best range of possible medical treatments, even 
     if that means doing or inventing something new just for them.
       We view this as our responsibility both as the leading 
     manufacturer of orthopaedic oncology prostheses in the United 
     States and as a global medical technology company with a 
     significant presence in other medical specialties, including 
     craniofacial deformities such as cleft lip and palate. We 
     take pride in partnering with and sponsoring a range of 
     medical organizations, including one which last year was able 
     to provide free cleft lip surgeries to 8,531 children in 23 
     countries. The surgery took only about 45 minutes and cost 
     $750 per child, but the corrective surgery changed, in a 
     positive way, forevermore the lives of each and every child 
     and the lives of their families too.
       We sincerely appreciate your leadership role on children's 
     issues. We take very seriously not only our commitment to 
     children with cancer and craniofacial deformities but also 
     our responsibility to ensure that our devices are safe and 
     effective for use in pediatric patients.
       As you may know, there has been significant progress over 
     the past two decades in the management of patients with 
     musculoskeletal cancers that has improved both the survival 
     rates and quality of life of afflicted individuals. Twenty 
     years ago, the standard treatment for any primary malignant 
     bone and soft tissue sarcomas of the extremity was amputation 
     of the affected arm or leg. Since that time, Stryker is proud 
     to have partnered with leading pediatric oncology surgeons to 
     develop limb-sparing, surgical solutions, including the 
     implantation of a growing prosthesis that can be elongated to 
     account for children's growth.
       As with cancer, the treatment of craniofacial deformities 
     is an area in which Stryker has also significantly improved 
     and broadened its range of available medical products and 
     solutions. With continued innovation of new and improved 
     craniomaxillofacial technologies, Stryker hopes to continue 
     to transform the lives of children with craniofacial 
     deformities, such as craniosynostis and cleft lip and palate 
     too.
       It is our hope that your legislation will further spur the 
     evolution of novel health care solutions for children. The 
     bill's efforts to streamline approvals for devices with 
     pediatric indications, improve incentives for the development 
     of devices for small pediatric populations, and encourage the 
     establishment of non-profit consortia for pediatric device 
     development should be commended.
       Stryker stands ready to assist you in your drive to 
     stimulate the further development of child-centered medical 
     technologies while closely monitoring the safety of such 
     products after they have entered the market. Thank you again 
     for your leadership on this important issue, and we look 
     forward to working with you to advance your bill as medical 
     device reauthorization legislation moves forward in the 110th 
     Congress.
           Sincerely,

                                                  Ed Rozynski,

                                                   Vice President,
     Global Government Affairs.
                                  ____


                                S. 4098

       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.

[[Page S11347]]

       ``(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

[[Page S11348]]

     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.

  Mr. DeWINE. Mr. President, today I join my colleague Senator Dodd to 
introduce a bill designed to help protect our Nation's children. Simply 
put, our bill would help ensure that our children have access to 
lifesaving medical devices that are designed specifically for their 
small bodies. Since the beginning of my career, my No. 1 priority has 
been to ensure that our children are healthy and safe. There is no 
other issue more important to me.
  Today, many medical devices used by pediatricians are not designed 
for children. That means that doctors have to fit adult sized devices 
into children's bodies. This is not right. We need to encourage the 
development of devices that are sized appropriately for children. 
According to pediatricians, medical devices sized appropriately for 
children are developed sometimes 5 to 10 years behind those for adults. 
The Pediatric Medical Device Safety and Improvement Act takes a step 
towards fixing this problem by providing incentives for manufacturers 
to develop devices for children while also ensuring the safety of new 
products once on the market.
  By introducing this bill, we are saying that we care about our 
children. We are saying that we care that children have access to 
lifesaving medical devices that are designed specifically for their 
small bodies. We are saying that we know we can do better for our 
children and this bill will do just that.
  We all want to see better health care options for our sick children. 
I believe that with this bill we are taking the first step to resolve a 
serious national health problem. While this legislation obviously will 
not pass this year, I know that Senator Dodd will continue to work on 
it next year and encourage my Republican colleagues to take a close 
look at this bill and support it in the 110th Congress.
  I ask unanimous consent that the text of the bill be printed in the 
Record.

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