I need your help once again! Please help Me and millions of other Diabetic’s get the care we deserve by “Asking the FDA to Better Serve Diabetes Patient’s Needs”. I have been living with Diabetes for a little over 4 years. I know there are a lot of items such as glucose meters, insulin, oral medication, cgm’s (continuous glucose monitors) and heck who know’s what else that maybe sitting on someone’s desk waiting to be approved. Why should we have to suffer? Why should we have to wait for approval for Diabetic research? WHY should we? honestly, we shouldn’t!
We are in a world full of change and believe it or not the healthcare industry needs a change, right along with the FDA!
There was a petition that was started yesterday at Healthe FDA.com! The Diabetic Community and Healthcare providers need your help. We need 20,000 signatures and we need your support. Please sign the petition at HealtheFDA.com…Don’t you think WE deserve it? I do.
The Letter Below is from Healthefda.com
The FDA’s job is to protect the safety of patients in its use of drugs and medical devices and to advance public health by speeding innovations that make medicines and technology more effective, safer and more affordable. That is its mission.
But we believe the FDA has adopted a stance of excessive caution in its regulation of diabetes drugs and technology that is counter to its duty to serve patient needs. Specifically, it has established new rules that will impair research and innovation into diabetes medications and devices.
New requirements for additional studies will assuredly discourage research and innovation to the detriment of public health.
The need for improved treatments for the 24 million Americans with diabetes could not be clearer. Many of the drugs available now have tolerability issues. Poorly controlled diabetes increases the risk of devastating long-term complications, including blindness, end-stage renal disease, amputation, and heart disease. Complications cost our country at least $58 billion per year -over twice what is spent on technology and therapy annually.
Nearly 50 percent of patients in the US do not meet A1c goals using current therapies and technologies. No therapy today stops diabetes from advancing. As patients are living longer with diabetes and therapies stop working, the need for new therapies increases. We need better technology and drugs that help slow or avoid long-term complications as well as more therapies that cause fewer side effects and last longer. And, despite the epidemic in the number of diabetic patients, no drugs are yet available that can prevent diabetes. Innovative, safe, and effective prevention is the key for people at risk and for cost savings to society.
Ironically, excessive regulatory hurdles ensure the continued use of the very drugs and devices that have proven ineffective for many patients.
There is no value in an ideal diabetes drug or device if the regulatory costs are so great that the product never makes it to market. Make rules reasonable.
We urge the new FDA leadership to recognize the urgent need for more safe and effective treatment options for diabetes and to reduce barriers to innovation. More treatment options will benefit patients. The disease is progressive. Delays in the availability of new treatments will only result in tremendous cost to public health and the economy. Our recommendation can benefit patients without sacrificing their safety.
Due to the very nature of the severity and prevalence of diabetes, the following leaders within the diabetes community, who have signed this petition, implore the FDA for the immediate creation of a Diabetes Advisory Council, whose goal would be to improve options for patients. This council would include practicing endocrinologists, diabetes educators and others communicating directly with patients. Our experience, focus, and keen awareness of the needs of the diabetes community would be an invaluable resource to the FDA as it faces the arduous process1 of evaluating new diabetes treatments. Our aim is to improve options for patients.
Thank you for taking the time to read our letter.
I signed my name…it’s your turn.