Reps. Mike Rogers (R-Mich.) and Ed Markey (D-Mass.)
Congressional Representatives Ed Markey (D-Mass.) and Mike Rogers (R-Mich.) introduced a bill that would require medical device makers to include pediatric information in certain FDA applications.
The same rule had been earlier withdrawn by the FDA after the agency received "significant adverse comment" upon implementing the change in the summer of 2010.
The rule "was intended to make noncontroversial amendments to existing regulations which would require the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols," according to FDALawBlog.net.
The provision is tucked into a larger bill aiming to reauthorize and extend the Pediatric Medical Device Safety & Improvement Act of 2007, granting device makers the ability to make profits on pediatric devices cleared under Humanitarian Device Exemption and extending a grant program for research on pediatric devices.
"Children are not simply smaller-sized adults, and their size, physique, and activity level means that their medical needs are very different from our own," Rep. Markey, also a senior member of the House Energy and Commerce Committee, said in prepared remarks. "Our original law has made good progress helping children get medical devices that are made uniquely for them, but there is more work to do. Without this reauthorization, we risk losing the incentives and innovation occurring now in support of developing these life-saving devices."
The press release did not mention the added data requirements for medical device applications, measures that industry advocate AdvaMed had spoken out against when they were proposed by the FDA.
"Companies that are interested and committed to pursuing pediatric use of their devices are stymied by a regulatory process that fails to recognize the significant challenges associated with widely dispersed and small pediatric populations," AdvaMed wrote in a public submission on the FDA’s proposed rule in June 2010. "These proposed revisions are neither minor nor noncontroversial. Requiring sponsors to provide speculative information about: possible pediatric uses for a device; pediatric subpopulations that could possible be affected by the disease or condition that a device is intended to treat, mitigate, or cure; or the number of pediatric patients that may possible be affected by that disease or condition, us unduly burdensome and without legal basis."
AdvaMed representatives are still working through the new legislation and denied to comment at this time.
