Contacting the FDA

Here is some useful information you can use when contacting your legislators or the media concerning the FDA's mandate to regulate our own stem cells as prescription drugs.

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_20...1cfr1271.3.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 recent furor concerning CNN's despicable coverage of stem cell treatments overseas has kept me pretty riled up over the lack of caring of the FDA and in general, the politicians in Washington D.C. What CNN did was simply, in their own bumbling way, magnify the situation that now exists for those of us that are terminally and chronically ill in this country. Our own government is holding us hostage. In an effort to please Big Pharma and not see their budget cut, the FDA must continue to create new avenues for their own agency. Declaring our own stem cells to be drugs is an avenue they could not resist even though they have no legal jurisdiction in the practice of medicine and they did NOT go through the required period of public commentary before making this declaration. This is a real no-no and something that ASCTA intends to challenge via the courts.

If you are not familiar with ASCTA (American Stem Cell Therapy Association), then get familiar by visiting their site at www.safestemcells.org. If you are a physician www.stemcelldocs.org You do not have to be a doctor that is giving stem cell treatment or even one that embraces it, however, if your patients choose to have treatment done, you must care enough to back this effort that promises safe treatments in the U.S. for them. You should also consider that the FDA's actions could threaten the way you treat your patients as well.

If we let the FDA take a pass on this gross overstepping of its regulatory boundaries, we will rue the day. Our own stem cells will become the domain of large pharmaceutical companies, setting progress back years in this country. We are already falling shamefully behind. Many countries allow treatments and many also offer clinicals for thousands and thousands of patients. The U.S. has a few clinicals and allows only a very limited number of treatments.

There should be no hold up on giving us what we need and want in this country. I am sick and tired of begging for my life and the life of others. I am tired of politicians who do not care enough to respond to letters, e-mails or phone calls and yet are always ready to take campaign contributions. Unless these politicians live in a fog, they have to know that we are a nation that is over medicated and on many fronts losing the battle to be number one in stem cell research and biotechnology. I am especially tired of lousy reporting filled with editorializing and outright lies as was the case with CNN.

We must fight back. We can't let the few brave doctors that are fighting for the right to give patients safe stem cell treatments be harassed and humiliated by the FDA and the press. We need to continue to expose the false premise the FDA is working under when they attempt to classify our own stem cells as drugs. This could open the door for the FDA to start regulating all surgeries, cosmetic procedures, stem cell products, etc. Do we really want that? I know I don't. I want my life back, not more regulation that threatens to take it away unless I make my way to Mexico or China or some other more visionary country.