Two House members have introduced a bill to speed development of pediatric devices that may prove unpopular with the industry. In fact, the FDA withdrew the same rule, which would have required devicemakers to include pediatric information in certain applications, in 2010 after a wave of devicemaker opposition.
Reps. Ed Markey (D-MA) and Mike Rogers (R-MI) last week introduced the The Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012 (H.R. 3975), which would reauthorize a 2007 law they co-authored. It created a grant program to speed the development of pediatric devices and encourage the creation of products to help children with rare conditions.
"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," Markey said in a statement. "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."
Advocates agree with his sentiments. In early 2010, the FDA announced that it would require companies to provide readily available information in certain premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure--even if it is only intended for adults. If the manufacturer did not submit such information, the FDA may not approve the application until the required data are provided.
But many in the industry weren't so happy, viewing the requirements as only adding to an already unwieldy situation. "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 proposed rule in June 2010. Furthermore, the use of the direct final rule procedure in this instance was improper because the proposed changes were "neither minor nor controversial," the group maintained. Indeed, the FDA can only use the direct final rulemaking procedures if it believes "there will be no significant adverse comment" to the rule--and that was not the case in this instance.
Whether this bill goes anywhere remains to be seen. But, given the anger it earlier aroused, there could be some congressional unease about the legislation.
- see the press release on the bill
- read the text of the legislation (.pdf)
- get more from MassDevice