| Ask FDA to Better Serve Diabetes Patients Needs | | Print | |
| Thursday, 15 January 2009 | |
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by Kelly Close of Close Concerns 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. The need for improved treatments for the 20 million people with diabetes could not be more clear. Many of the drugs available now have safety and tolerability issues. Many patients do not meet A1c goals using current therapies and technologies and none of these can stop or reverse diabetes from advancing. We need better technology and drugs that help slow or avoid long-term complications. And, despite an epidemic status in numbers of diabetic patients, no drugs are yet available that can prevent diabetes. Innovative, safe, and effective preventions are the ultimate key for people at risk and to cost savings in the health care system. Those issues contribute to poor outcomes, and poor outcomes contribute to diabetes-related complications, on which our country spends $58 billion a year (compared to half as much for treatments). Ironically, excessive regulatory hurdles ensure the continued use of the very drugs and devices that have proven ineffective for so many patients. We see no value in the perfect diabetes drug or device, or even a very good one, if the regulatory costs are so great that the product never makes it to market. Make rules reasonable. We hereby urge the new FDA leadership to make the rules reasonable! We urge them recognize that a greater emphasis needs to be placed on improving treatment options for diabetes. This can benefit patients without sacrificing their safety. Please sign this petition and tell others about it. Make your voice heard!
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