Here is some useful information you can use when contacting your legislators or the media.
The FDA has taken the position that our own adult stem cells are biological drugs. You can view the FDA?s code of regulations at http://edocket.access.gpo.gov/cfr_2005/aprqtr/21cfr1271.3.htm The FDA defines stem cells as a type of ?human cell, tissue, or cellular or tissue-based products? (HCT/P?s). You will want to focus on 21 CFR 1271.3(d). It defines HCT/P?s as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.?
Over the past 5 years that definition has undergone a very significant change. Originally, human cell tissue/products were defined as ?any human tissue derived from a human body and intended for transplantation into another human?.
Do you see the significance of the change? The new regulation currently in effect purports to give the FDA the authority to regulate even those tissue products being used for autologous purposes such as tissue products being used in a bypass surgery or our own stem cells being used in our own treatments. The change in wording in this regulation gives the FDA more authority than Congress has ever authorized.
The really shocking part of all of this is that the FDA made these changes to the law without public comment. Federal law states that the FDA cannot make new regulations without giving notice to the public and offering the public the opportunity to comment.
Undoubtedly if the FDA had followed the proper procedure, the proposed change would have infuriated doctors and others involved in medical procedures because the new regulation purports to give the FDA the authority to regulate the practice of medicine, something Congress has NEVER granted to the FDA.
By changing just this one little simple phrase in the regulations, the agency has given itself vast new powers to regulate stem cells as biological drugs. The cell based therapy group at the FDA (CBER) depends on this little phrase for its existence. Without the phrase, the FDA has no authority to regulate our own stem cells as a drug. With the phrase, the FDA gives itself unheard of authority and a whole new section of the federal government (CBER) a reason to exist.
This is why ASCTA (American Stem Cell Therapy Association) is so important. Working together we can rectify this situation and return the practice of medicine to physicians working with patients concerning their personal healthcare. To begin this process, please join ASCTA at www.safestemcells.org If you are a physician go to www.stemcelldocs.org Once there, you will find a link to contact the FDA. The following is a suggested message you can send:
Gentlemen:
I oppose the change made in 21 CFR 1271.3(d) from ?any human tissue derived from a human body and intended for transplantation into another human?? (2004 and prior) to ?articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.? (recent regulation). This change allows the FDA to regulate the practice of medicine, even though Congress never gave the FDA such power. Please put this regulation change to public comment as is required by law.
The FDA has taken the position that our own adult stem cells are biological drugs. You can view the FDA?s code of regulations at http://edocket.access.gpo.gov/cfr_2005/aprqtr/21cfr1271.3.htm The FDA defines stem cells as a type of ?human cell, tissue, or cellular or tissue-based products? (HCT/P?s). You will want to focus on 21 CFR 1271.3(d). It defines HCT/P?s as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.?
Over the past 5 years that definition has undergone a very significant change. Originally, human cell tissue/products were defined as ?any human tissue derived from a human body and intended for transplantation into another human?.
Do you see the significance of the change? The new regulation currently in effect purports to give the FDA the authority to regulate even those tissue products being used for autologous purposes such as tissue products being used in a bypass surgery or our own stem cells being used in our own treatments. The change in wording in this regulation gives the FDA more authority than Congress has ever authorized.
The really shocking part of all of this is that the FDA made these changes to the law without public comment. Federal law states that the FDA cannot make new regulations without giving notice to the public and offering the public the opportunity to comment.
Undoubtedly if the FDA had followed the proper procedure, the proposed change would have infuriated doctors and others involved in medical procedures because the new regulation purports to give the FDA the authority to regulate the practice of medicine, something Congress has NEVER granted to the FDA.
By changing just this one little simple phrase in the regulations, the agency has given itself vast new powers to regulate stem cells as biological drugs. The cell based therapy group at the FDA (CBER) depends on this little phrase for its existence. Without the phrase, the FDA has no authority to regulate our own stem cells as a drug. With the phrase, the FDA gives itself unheard of authority and a whole new section of the federal government (CBER) a reason to exist.
This is why ASCTA (American Stem Cell Therapy Association) is so important. Working together we can rectify this situation and return the practice of medicine to physicians working with patients concerning their personal healthcare. To begin this process, please join ASCTA at www.safestemcells.org If you are a physician go to www.stemcelldocs.org Once there, you will find a link to contact the FDA. The following is a suggested message you can send:
Gentlemen:
I oppose the change made in 21 CFR 1271.3(d) from ?any human tissue derived from a human body and intended for transplantation into another human?? (2004 and prior) to ?articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.? (recent regulation). This change allows the FDA to regulate the practice of medicine, even though Congress never gave the FDA such power. Please put this regulation change to public comment as is required by law.