Monday, June 15, 2015
What does a female condom have in common with a hip replacement?
[Re-post from NWHN e-newsletter 6/11/15]
What does a female condom have in common with a hip replacement? Not much, obviously. At least it’s obvious to us. But the FDA treats female condoms as if they need the same level of stringent regulatory oversight as hip replacements and other implanted devices. That’s just not right!
I’ve written to you before about how female condoms are a great option for safer sex. Despite being safe and effective at preventing HIV, sexually transmitted infections (STI's) and unintended pregnancy, the FDA has labeled female condoms as a Class III medical device, the highest level of regulation. Male condoms are treated as Class II devices, which means that the FDA ensures that good manufacturing practices are followed, and changes aren’t made that could compromise safety and effectiveness. But otherwise, the FDA doesn’t over-regulate male condom. Needlessly classifying female condoms in the highest regulatory category creates barriers to female condom accessibility and affordability. Only one female condom is FDA approved and available in the U.S. and permitted to be purchased with U.S. foreign aid. Women and men deserve to choose the method of family planning and STI prevention that is right for them without facing unnecessary obstacles.
Last week, Network Program Director Coco Jervis participated in this informative webinar about current FDA regulatory opportunities for removing barriers. We have been working with our coalition partners at the National Female Condom Coalition to urge the FDA to down-classify female condoms to enable new options for women in the U.S. and across the globe. To help us remove barriers to new female condom products, take action today and share some of these fantastic NFCC resources and help spread the message that people need more options for safer sex.
The Network will continue working with our allies to ensure access to a full range of preventive options for pregnancy and STI transmission. Follow us on Facebook and Twitter to receive for the most up-to-date information on our advocacy!