Don't Be a Test Subject for the Medical Device Industry!
- al: Consumers Union
- destinatario: U.S. Congress
You've made it clear that safety testing medical devices first, and tracking them in case they go bad and need to be removed later, just makes sense.
Yet the House bill that will set safety rules for a medical device that your doctor may use on you someday does neither. This week House members can fix that, and if constituents like you speak out and put the pressure on now, we might change this bad bill.
Please take a moment to tell your Representative that using you and your family as test subjects for medical device safety isn't good enough. Tell them you want common sense safety testing and tracking—and if you have a personal experience with a medical device, share it with them in the comments box.
Yet the House bill that will set safety rules for a medical device that your doctor may use on you someday does neither. This week House members can fix that, and if constituents like you speak out and put the pressure on now, we might change this bad bill.
Please take a moment to tell your Representative that using you and your family as test subjects for medical device safety isn't good enough. Tell them you want common sense safety testing and tracking—and if you have a personal experience with a medical device, share it with them in the comments box.
Dear [Decision Maker],
As your constituent, I count on you to make sure medical devices are proven safe and effective before they're sold to me, and that they are effectively tracked if there is a safety problem later. Yet the Medical Device User Fee Act reauthorization proposed by the Energy and Commerce committee does neither, and I urge you to strengthen this bill for consumers before it comes up for a final vote.
[Your comments here]
Recently we've seen large-scale failures of hip replacements, surgical mesh and cardiac defibrillators that have led to tens of thousands of American deaths and injuries. We should be improving our safety rules so we can avoid these costly and deadly problems upfront, rather than spending so much of our nation's money trying to fix them after the fact.
Most high-risk devices are now cleared through FDA's fast-track 510(k) process, which in most cases requires no evidence of clinical safety testing before a device is sold. Instead, manufacturers only have to show that the device is similar to another device that was recalled for a safety problem!
That just doesn't make sense, which is why I believe each implant should be tested for safety, even when similar devices are in use. A recent Consumer Reports poll found that 91 percent of Americans agree that such safety testing should be required.
As you work on this bill, please do all you can to make these common-sense improvements to ensure safe and effective devices get to market without slowing innovation:
1) Don't allow new devices on the market if they're based on recalled devices.
2) Create an effective way to monitor devices and notify patients if there is a problem. Five years ago Congress OK'd a unique device identifier system, similar to a car's VIN number, to easily monitor devices and inform patients of problems, but it's never been put in place. We do that for everything from cars to coffeemakers--it's time to do it for implants.
3) Make studies of safety problems happen faster. These studies should begin within nine months of being ordered by the FDA; right now there is no deadline. And if a study shows that a device is unsafe or ineffective, the FDA should be able to rescind its prior clearance of it.
4) Make sure those deciding whether a device or drug gets on the market don't have a conflict of interest. Keep current law that requires conflicts be disclosed and limits people with significant financial interest in a device or drug from participating on an advisory panel reviewing the device or drug.
5) Let the FDA ask for important information from manufacturers so it can assess a device's safety and effectiveness. The House bill would restrict the agency's ability to ask for the information it needs.
6) Make sure industry fees help cover costs. This draft bill increases current user fees, which is good. But I'm concerned the funding will only cover about one-third of the FDA's costs for reviewing and monitoring devices, especially since the volume and complexity of medical devices will significantly increase over the next five years.
I know this is a lengthy list, but I can count on you to represent constituents like me who want to make sure the medical device I may need someday is safe, effective, and available. Please support these common-sense improvements to the MDUFA bill as it works its way through the House.
Thank you for your consideration.
Sincerely,
[Your name here]
firma la peticiónfirma la peticiónAs your constituent, I count on you to make sure medical devices are proven safe and effective before they're sold to me, and that they are effectively tracked if there is a safety problem later. Yet the Medical Device User Fee Act reauthorization proposed by the Energy and Commerce committee does neither, and I urge you to strengthen this bill for consumers before it comes up for a final vote.
[Your comments here]
Recently we've seen large-scale failures of hip replacements, surgical mesh and cardiac defibrillators that have led to tens of thousands of American deaths and injuries. We should be improving our safety rules so we can avoid these costly and deadly problems upfront, rather than spending so much of our nation's money trying to fix them after the fact.
Most high-risk devices are now cleared through FDA's fast-track 510(k) process, which in most cases requires no evidence of clinical safety testing before a device is sold. Instead, manufacturers only have to show that the device is similar to another device that was recalled for a safety problem!
That just doesn't make sense, which is why I believe each implant should be tested for safety, even when similar devices are in use. A recent Consumer Reports poll found that 91 percent of Americans agree that such safety testing should be required.
As you work on this bill, please do all you can to make these common-sense improvements to ensure safe and effective devices get to market without slowing innovation:
1) Don't allow new devices on the market if they're based on recalled devices.
2) Create an effective way to monitor devices and notify patients if there is a problem. Five years ago Congress OK'd a unique device identifier system, similar to a car's VIN number, to easily monitor devices and inform patients of problems, but it's never been put in place. We do that for everything from cars to coffeemakers--it's time to do it for implants.
3) Make studies of safety problems happen faster. These studies should begin within nine months of being ordered by the FDA; right now there is no deadline. And if a study shows that a device is unsafe or ineffective, the FDA should be able to rescind its prior clearance of it.
4) Make sure those deciding whether a device or drug gets on the market don't have a conflict of interest. Keep current law that requires conflicts be disclosed and limits people with significant financial interest in a device or drug from participating on an advisory panel reviewing the device or drug.
5) Let the FDA ask for important information from manufacturers so it can assess a device's safety and effectiveness. The House bill would restrict the agency's ability to ask for the information it needs.
6) Make sure industry fees help cover costs. This draft bill increases current user fees, which is good. But I'm concerned the funding will only cover about one-third of the FDA's costs for reviewing and monitoring devices, especially since the volume and complexity of medical devices will significantly increase over the next five years.
I know this is a lengthy list, but I can count on you to represent constituents like me who want to make sure the medical device I may need someday is safe, effective, and available. Please support these common-sense improvements to the MDUFA bill as it works its way through the House.
Thank you for your consideration.
Sincerely,
[Your name here]
Ver más peticiones:
Has deshabilitado JavaScript. Sin este programa, puede que nuestro sitio no funcione debidamente.
al firmar, aceptas los condiciones del servicio de Care2 Puede administrar sus suscripciones por correo electrónico en cualquier momento.
¿Tienes dificultades para firmarla?? Infórmanos.