SRS/POSNA Task Force Meets with FDA
On November 14, 2011, the Scoliosis Research Society (SRS) and Pediatric Orthopaedic Society of North America (POSNA) task force on pediatric medical devices attended meetings with Food and Drug Administration (FDA) officials at the Silver Spring, Maryland White Oak campus. Despite legislative efforts included in the last FDA user fee bill, the Pediatric Medical Device Safety Act has not produced a marked increase in the availability of new devices for pediatric orthopaedic indications. The SRS/POSNA task force stated that regulatory processes must balance protections for patients with the need for innovation and the evolution of care. Pediatric device innovation is inherently different than in the adult population due to 1) small markets 2) weak financial incentives 3) liability concerns and 4) methodological challenges of small clinical trial populations. Pediatric orthopaedic surgeons use many devices off-label, often referred to as physician-directed applications. This practice is becoming increasingly problematic because there is rising payer denial of coverage when physician-directed applications are used, there is an increased threat to education and research, and the medical device industry is concerned about prosecution for off-label promotion. The FDA officials pledged to work with the SRS/POSNA task force and manufacturers to find ways to provide labeled indications for some pediatric devices, where sufficient data exists. Some foreign data may be appropriate for certain data requirements for select devices. The SRS/POSNA task force agreed to draft a guidance document on skeletal maturity and submit that to the FDA. Modifications to the Pediatric Medical Device Safety Act are expected by the legislative deadline of September 30, 2012 which may change the landscape slightly for the availability of pediatric orthopaedic devices.
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