Fast Track the evaluation and approval of breakthrough treatments.

The Issue

Now that Washington  has passed and President Obama has signed the Food and Drug Administration Safety and Innovation Act to break through the bureaucratic roadblocks and speed up the FDA process of approving promising treatments, it is time for the FDA to take advantage of this new law.  In the past the FDA has evaluated 21st century treatments with 20th century processes. We are at the threshold of a new era of regenerative medicine and Stem Cell treatments and the FDA must align themselves for the benefit of the greater good of those in need. Advanced Cell Technology Company is conducting the only current FDA approved clinical trials for embryonic stem cell treatment on humans and has shown great promise with effectiveness and safety in treating blindness, and we need to fast track the process and protocols to bring this science to those in need.  

The following was recently written by the former FDA Commissioner Andy von Eschenbach. 

"Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them. Take regenerative medicine. If a company can grow cells that repair the retina in a lab, patients who've been blinded by macular degeneration shouldn't have to wait years while the FDA asks the company to complete laborious clinical trials proving efficacy. Instead, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies." 

"When I was commissioner of the Food and Drug Administration (FDA) from 2005 to 2009, I saw firsthand how regenerative medicine offered a cure for blindness,  kidney and heart failure and other chronic conditions like diabetes. Researchers used stem cells to grow cells and tissues to replace failing organs, eliminating the need for expensive supportive treatments like dialysis and organ transplants."

This common sense legislation ensures that patients across the country can receive breakthrough treatments faster and more efficiently than ever before. Time and again we’ve seen regulators in Washington fail to keep up with the industries they are tasked to oversee. When it comes to treating patients suffering with blindness, cancer or other devastating illnesses, science and patient care will not be slowed down by government red tape.

Now that the law has passed, it is up to the FDA to use this new legislated freedom to fast track stem cell clinical trials thus allowing these 21st century treatments to become a reality. 

Please sign up for this petition and let’s show the FDA we support the fast tracking of breakthrough sciences. Every time someone signs this petition 16 email letters are sent to the heads of the FDA encouraging them to take advantage of this new law. Let's cure blindness now.

This petition had 846 supporters

The Issue

Now that Washington  has passed and President Obama has signed the Food and Drug Administration Safety and Innovation Act to break through the bureaucratic roadblocks and speed up the FDA process of approving promising treatments, it is time for the FDA to take advantage of this new law.  In the past the FDA has evaluated 21st century treatments with 20th century processes. We are at the threshold of a new era of regenerative medicine and Stem Cell treatments and the FDA must align themselves for the benefit of the greater good of those in need. Advanced Cell Technology Company is conducting the only current FDA approved clinical trials for embryonic stem cell treatment on humans and has shown great promise with effectiveness and safety in treating blindness, and we need to fast track the process and protocols to bring this science to those in need.  

The following was recently written by the former FDA Commissioner Andy von Eschenbach. 

"Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them. Take regenerative medicine. If a company can grow cells that repair the retina in a lab, patients who've been blinded by macular degeneration shouldn't have to wait years while the FDA asks the company to complete laborious clinical trials proving efficacy. Instead, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies." 

"When I was commissioner of the Food and Drug Administration (FDA) from 2005 to 2009, I saw firsthand how regenerative medicine offered a cure for blindness,  kidney and heart failure and other chronic conditions like diabetes. Researchers used stem cells to grow cells and tissues to replace failing organs, eliminating the need for expensive supportive treatments like dialysis and organ transplants."

This common sense legislation ensures that patients across the country can receive breakthrough treatments faster and more efficiently than ever before. Time and again we’ve seen regulators in Washington fail to keep up with the industries they are tasked to oversee. When it comes to treating patients suffering with blindness, cancer or other devastating illnesses, science and patient care will not be slowed down by government red tape.

Now that the law has passed, it is up to the FDA to use this new legislated freedom to fast track stem cell clinical trials thus allowing these 21st century treatments to become a reality. 

Please sign up for this petition and let’s show the FDA we support the fast tracking of breakthrough sciences. Every time someone signs this petition 16 email letters are sent to the heads of the FDA encouraging them to take advantage of this new law. Let's cure blindness now.

Petition Closed

This petition had 846 supporters

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The Decision Makers

Maria Velasco
Maria Velasco
FDA Southwest
Malcolm Moos
Malcolm Moos
Director
Anitra D. Brown-Reed
Anitra D. Brown-Reed
FDA Central Office
JoAnn Pittman
JoAnn Pittman
FDA Southeast
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