National Women's Health Network - Comment

Comments of the National Women’s Health Network on Medical Device User Fees (MDUFA) [Docket no. FDA-2010-N-0389-0008] November 1, 2010 The National Women’s Health Network is a nonprofit advocacy organization that works to improve the health of all women. We bring the voices of women consumers to the policy and regulatory decision-making bodies. I appreciate the opportunity to speak to you today about ways in which the medical device program can be strengthened, in particular as it relates to ensuring the safety and effectiveness of devices for women. Women use and depend on a wide range of medical devices that are intended specifically for them – from female condoms, to breast implants, to bladder slings – as well as many devices that are used by both men and women. We rely on the FDA to ensure that devices will only be approved and made available if they are both safe and effective and that approved devices will be manufactured and marketed according to the highest safety standards. As some of you surely know, the NWHN has a long history of working with the FDA and while we often play the role of critic, we are staunch advocates of the critically important contribution that the agency makes to the health and well-being of the country. Our criticisms come from our commitment to improving the FDA’s ability to protect the public from exposure to unnecessary medical risks caused by unsafe drugs and medical devices. And I offer these comments today in that spirit. Our comments focus on raising scientific standards and wielding regulatory authority – but before I delve into those specifically, I want to acknowledge a fundamental problem that we believe underlies and exacerbates other concerns we have about the medical device program. Since 2002, the device program has been funded in significant part by user fees that are tied directly and specifically to performance standards set by the agency in negotiation with the industry it is responsible for