Congress, Industry Aim to Broaden Pediatric Device Research
BY LAUREN UZDIENSKI, APRIL 4, 2007
With a small market and conditions that are relatively rare, pediatrics hasn't drawn a lot of product development in the device space. As a result, children may receive devices that aren't appropriately sized for them or are lacking in data from pediatric trials. Now a bill introduced on the Senate floor could encourage new research.
Sen. Chris Dodd's (D-Conn) office announced last month that he was reintroducing the Pediatric Medical Device Safety and Improvement Act of 2007, which would consist of a number of measures to incentivize devicemakers as well as to simplify the regulatory process. A sample of the measures include:
-Profit will be allowed for HDE devices specifically designed for children, with no profit for a device used in more than 4,000 individuals;
-An FDA database will track the number and types of devices for children or pediatric conditions, as well as the premarket application and HDE approval status;
-The NIH will create a liason point between devicemakers and physicians and funding sources.
The legislation will help to mitigate some of the financial concerns surrounding R&D for pediatric devices, though manufacturers are still faced with designing devices for a population smaller and likely more active and more dependent on safe, long-lasting implants than the majority of their market. Additionally, development incentives could draw more orthopedic surgeons into a pediatric speciality - the number of peds orthopedic surgeons is decreasing.
These factors can explain the general lack of device activity to date, but one company tackling pediatric ortho on the prognostic front is Axial Biotech. The company is in the process of developing a test that will predict severe scoliosis in adolescents, and their efforts are being backed by funding from DePuy and Medtronic, among others. Paired with Sen. Dodd's legislation, industry support could spark new interest in pediatric indications.
Though the fate of Sen. Dodd's law is not yet known, Congress has encouraged pediatric research in the past. In 2002, Congress adopted a similar initiative for pharma, the Best Pharmaceuticals for Children Act, which grants six-month exclusivity to manufacturers producing a drug for children.
