Not much has more red tape than the regulatory gauntlet drug companies have to go through to get drugs FDA approved and to market. From one perspective, that red tape may help to keep humans from being experimental subjects for drugs not ready for market. On the other hand, those facing potentially terminal diseases link cancer, AIDS, to name a few, need new options and may not have any other options. Researchers and doctors regularly must go "off label" using drugs in new ways, but not yet approved by the FDA, to find new ways to battle these diseases.
The good news is we have had some regulatory relief thanks to U.S. Rep. Gabrielle Giffords' sponsored bill, The Safe and Effective Drug Development Act of 2007. Signed into law last week, this bill began as H.R. 2592. According to Giffords, this "encourages the establishment of a neutral territory within which
companies can work together and share their experiences with each other
and the (FDA) scientists." It allows companies working cooperatively with the FDA to get drugs to the field faster and support additional FDA monitoring of the drugs.
I have a friend Jason who has reached the end of his options with his current doctors for treating pancreatic cancer. He is now heading to a research hospital who specializes in treating cancer holistically and working on new studies and treatment options. Bills like H.R. 2592 offer Jason and so many others hope for treating their disease. My prayers and best wishes are with Jason and his young family.
Democratic Rep. Gifford has done something that will help us all. This is the kind of good work I wish all our representatives and senators would do. Thank you, Gabrielle Gifford.
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