Full article reprinted from "The Gray Sheet" - March 09, 2009
FDA and industry are collaborating on a handful of pediatric device development projects, building on requirements from Congress.
FDA, Device Firms Take Initiative With New Pediatric Projects
The 2007 FDA Amendments Act includes the Pediatric Medical Device Safety and Improvement Act, with incentives for industry and researchers to focus on designing devices for children.
Among other things, the law requires FDA, the National Institutes of Health and the Agency for Healthcare Research and Quality to submit to Congress long-term plans for spurring pediatric device development.
FDA and NIH say the reports, due last year, should get to the Hill shortly.
NIH's National Institute of Child Health and Human Development will propose to review grant proposals for pediatric device projects with a special eye to ensuring grantees have considered the need for eventual commercialization (1"The Gray Sheet" Aug. 11, 2008, p. 7).
In the meantime, the institute is hosting a series of workshops on pediatric product development, including one last August and a second late last month. Another meeting planned for April 23 will discuss institutional review board best practices for companies and clinicians conducting pediatric trials.
FDA, meanwhile, is focused in part on fulfilling some of the specific requirements of the pediatric act, such as tracking pediatric use of devices and ensuring that product sponsors include pediatric population data in pre-market submissions.
In addition to the long-term plans report, the agency needs to submit data annually to Congress on pediatric device submissions, devices with potential pediatric subpopulations and average review times of products with pediatric applications.
But the agency's device center says it is also taking it upon itself to initiate projects to improve pediatric device design.
FDA Cardio Branch Gets More Kid-Friendly
In 2006, CDRH held a workshop on developing pediatric circulatory support devices (2"The Gray Sheet" Jan. 30, 2006, p. 11). Since then, the center's cardiovascular review team has continued to focus some resources on bridging gaps in designing devices for children.
"Pediatric device development is a key program area for the division of cardiovascular devices this year," division director Bram Zuckerman told "The Gray Sheet."
Ashley Boam, the division's interventional cardiology devices branch chief, is working with visiting pediatrician fellow Francesca Dolcimascolo on one such project.
"We're building on the spirit of those legislative changes," Boam said.
Dolcimascolo, a pediatrician at the Children's National Medical Center in Washington, D.C., began her two-year stint with the agency in October 2008 as part of the FDA Commissioner's Fellowship Program.
The pair hopes to advance pediatric cardiovascular device development through education and outreach initiatives and by working with experts on alternative trial designs.
They are also working with professional societies to develop device registries that could help inform future pediatric trials and enhance post-market surveillance.
"There seem to be a number of clinicians in this area who responded favorably to our initial outreach and seem to want to work collaboratively with us to move this along," Boam said in an interview.
FDA has long been interested in addressing unmet needs in pediatric device development, but reviewers get bogged down by other responsibilities, she said. "The clinical community has become used to fending for themselves - making modifications to adult devices to make them work."
"We're trying to figure out ways to bring some of that innovation and creative thinking so we can get devices developed specifically for them, and get devices labeled for use in kids," Boam said.
The project may tackle technologies such as pediatric heart valves, patent foramen ovale closure devices and aortic stents, among others.
Industry Seeks Special Path To Peds Heart Valves
The device industry also says it is trying to make strides in this space, despite concerns about the difficulties and cost of pediatric trials and limited market potential (3"The Gray Sheet" April 14, 2008, p. 12).
An AdvaMed working group is engaging with FDA to craft new regulatory strategies to help firms develop smaller heart valves for pediatric patients without adding cost-prohibitive requirements. The trade group plans to submit a proposal to the agency soon.
"We would never propose a lower bar for evidence," said Jeffrey Secunda, associate VP of technology and regulatory affairs at AdvaMed. "It's really looking at the heart valve as a device for which there's a lot of clinical evidence and trying to leverage what's already in existence."
"We've been quite impressed that certain parts of the industry are willing to rethink the way that they're developing devices, such that pediatrics isn't forgotten," FDA's Zuckerman acknowledged.
The agency is also working with the Society for Cardiac Angiography and Interventions to create alternative acceptable pediatric device trial designs.
On a global scale, FDA is coordinating with international agencies to assure that children are not enrolled in duplicative or unsound clinical trials.
"Pediatric therapeutic development ... is going to become progressively global," Dianne Murphy, director of FDA's Office of Pediatric Therapeutics, said at the Feb. 26 NIH pediatric products stakeholder meeting.
"What we're trying to do is ensure that we know what's going on, on both sides of the ocean."
- Jessica Bylander
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