Statements on Introduced Bills and Joint Resolutions
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - March 08, 2007)
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By Mr. DODD:
S. 830. A bill to improve the process for the development of needed pediatric medial 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 2007. 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 ``jury-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. So, infants and children under five 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 several years, 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 medical 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 post-market studies of certain products and improve public access to information about post-market pediatric studies.
This 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. The 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, the 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 number allowed under current law. Already approved adult HDEs upon date of enactment are eligible for the HDE profit modification but only if they meet the conditions of the bill. The lifting of the profit restriction for new pediatric HDEs sunsets in 2013 and the FDA is required to issue a report on its impact within five years.
In order to encourage pediatric medical device research, the 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, the 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 the federal government to 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. The 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 three 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 I am introducing today has been many years in the making. Last year, I introduced this legislation with Senator DeWine and I thank him for working with me on it and many other initiatives to improve children's health. I would like to also 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 tireless work and support for this legislation. The bill I am introducing today is supported by the Advanced Medical Technology Association (AdvaMed) and its member company Stryker and I thank them for their support. The bill reflects many of the comments they provided throughout the development of this legislation and I am pleased that they join me today in supporting its passage. Several other device manufacturers including Respironics, Seleon, and Breas Medical AB have previously supported this legislation and I would like to recognize and thank them for their continued support of the bill.
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 Kennedy and Enzi--to move this legislation when the Committee considers medical device-related 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 text of the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be printed in the RECORD, as follows:
S. 830
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