URGENT - S1082 What to do before TODAY's vote
Posted: Thu May 03, 2007 1:34 pm
Rosemary and others,
This lays out the issues - tells you where the clause is that can be used to potentially regulate supplements and gives a letter about the amendments that it is easy to send to your Senators. Put into the context of the forthcoming Codex etc. these extended powers of the FDA will not be good for any of us on the CAM side and do nothing to protect the public from another Vioxx debacle.
I tried to keep the info as brief as possible while at the same time clarifying the issues.
Carol
Carol Boyce MCH, CCH, RSHom(NA)
S1082 Update Tuesday's Activity. Fight Erupts on Senate floor:
( between the authors and their supporters and those wanting to amend the bill. See what to do at the end - please send the letter describing the amendments to your Senators before the vote tomorrow.) CB
"At issue is an amendment that Dorgan has added to S1082, one that is vehemently opposed by the authors of the bill and by the White House. Dorgan's amendment calls for Americans to be able to purchase prescription drugs from other countries. This would bring to an end the Big Pharma price-fixing that has Americans paying at least twice as much for the same drugs. Bush is threatening to veto the entire bill if the Dorgan amendment is part of the legislation.
A Vote is Likely on Thursday
Word from the hill is that all amendments and changes to this legislation will be finalized by Thursday and a vote will take place. In addition to the Dorgan amendment several other amendments are expected to come up - one very good and one very bad. The good amendment will be proposed by Senator Grassley (R-IA) and will seek to create an independent office within the FDA to monitor the safety of drugs already on the market (this would be another big blow to this legislation). The bad amendment will come from the vitamin-hating Dick Durbin (D-IL) who will try to place food safety legislation into this drug safety bill.
We must also get our amendment, THE PEOPLE'S AMENDMENT, into this legislation (see action letter following this article).
The People are Now Being Heard
We have word that the offices of Hatch, Harkin, Enzi, Kennedy, and many other Senators are being flooded by your concerns regarding what this bill can do to undermine health freedom and your access to dietary supplements. Their offices are seeking to tell those who get through that we are confused and that the legislation is not about dietary supplements.
We are not confused. The language in the bill is crystal clear. On pages 106-107 it states:
This language has been evaluated by Jonathan Emord, our nation's leading attorney that defends health freedom, the man who has beaten the FDA in court more than any other lawyer. He states that this language gives the FDA, through this foundation, broad new regulatory power that it currently does not possess, including the authority to attack any dietary supplement (which are food ingredients). A simple amendment to correct this problem has been prepared by Emord and is in the action letter that follows. WE ARE BEING HEARD. KEEP SENDING IN YOUR MESSAGES. We can win this!
WHAT TO DO: EMAIL THIS LETTER TO YOUR SENATORS:
You can get your Senator's info here and cut and paste the letter into their webform:
http://www.senate.gov/general/contact_i ... rs_cfm.cfm
May 2, 2007
The Honorable (Senator First and Last Name)
Address
Dear Senator Last Name;
The issue of drug safety and access to drugs at a fair price is of the utmost importance to myself and all Americans. In general, I am opposed to Senate bill S1082: Food and Drug Administration Revitalization Act, as it does not go far enough to protect myself and my family from the dangers of drugs. As one of the 150 million Americans that rely on dietary supplements to keep myself and my family well, I am especially concerned that this legislation broadens FDA regulatory power to harass functional foods and dietary supplements - which has nothing whatsoever to do with drug safety.
It is vital that the terms 'food' and 'food ingredients' be removed from this legislation. There must be no confusing the safety of drugs and the safety of food and food ingredients which are governed by different laws. This bill authorizes, on pages 106-107, the creation of a new regulatory category that enables the FDA and the Reagan-Udall Foundation for the FDA to attack dietary supplements and functional foods. This problem in the wording can be corrected with this simple amendment so as to be sure this legislation is about drugs and drug safety only.
Amendment to Bill S1082
Purpose of the amendment:
The bill, S1082: The Food and Drug Administration Revitalization Act, is hereby amended to eliminate any reference to the terms food or food ingredients, such that food and food ingredients will not be subject to any jurisdiction or control by the Regan-Udall Foundation for the Food and Drug Administration.
Intent of amendment:
To eliminate from the bill any possibility that food or food ingredients would be treated like drugs either for safety review purposes or for assessment of their efficacy. It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury.
I am in favor of the Dorgan amendment that enables Americans to get a fair price on prescription medication.
I am in favor of any Grassley amendment that offers an independent office within the FDA to monitor the safety of drugs already on the market.
I am opposed to the amendment being prepared by Durbin, as food safety is a completely different issue and must be kept out of drug safety legislation so that there can be no confusion between drug safety and food safety laws - which are quite different.
Sincerely,
This lays out the issues - tells you where the clause is that can be used to potentially regulate supplements and gives a letter about the amendments that it is easy to send to your Senators. Put into the context of the forthcoming Codex etc. these extended powers of the FDA will not be good for any of us on the CAM side and do nothing to protect the public from another Vioxx debacle.
I tried to keep the info as brief as possible while at the same time clarifying the issues.
Carol
Carol Boyce MCH, CCH, RSHom(NA)
S1082 Update Tuesday's Activity. Fight Erupts on Senate floor:
( between the authors and their supporters and those wanting to amend the bill. See what to do at the end - please send the letter describing the amendments to your Senators before the vote tomorrow.) CB
"At issue is an amendment that Dorgan has added to S1082, one that is vehemently opposed by the authors of the bill and by the White House. Dorgan's amendment calls for Americans to be able to purchase prescription drugs from other countries. This would bring to an end the Big Pharma price-fixing that has Americans paying at least twice as much for the same drugs. Bush is threatening to veto the entire bill if the Dorgan amendment is part of the legislation.
A Vote is Likely on Thursday
Word from the hill is that all amendments and changes to this legislation will be finalized by Thursday and a vote will take place. In addition to the Dorgan amendment several other amendments are expected to come up - one very good and one very bad. The good amendment will be proposed by Senator Grassley (R-IA) and will seek to create an independent office within the FDA to monitor the safety of drugs already on the market (this would be another big blow to this legislation). The bad amendment will come from the vitamin-hating Dick Durbin (D-IL) who will try to place food safety legislation into this drug safety bill.
We must also get our amendment, THE PEOPLE'S AMENDMENT, into this legislation (see action letter following this article).
The People are Now Being Heard
We have word that the offices of Hatch, Harkin, Enzi, Kennedy, and many other Senators are being flooded by your concerns regarding what this bill can do to undermine health freedom and your access to dietary supplements. Their offices are seeking to tell those who get through that we are confused and that the legislation is not about dietary supplements.
We are not confused. The language in the bill is crystal clear. On pages 106-107 it states:
This language has been evaluated by Jonathan Emord, our nation's leading attorney that defends health freedom, the man who has beaten the FDA in court more than any other lawyer. He states that this language gives the FDA, through this foundation, broad new regulatory power that it currently does not possess, including the authority to attack any dietary supplement (which are food ingredients). A simple amendment to correct this problem has been prepared by Emord and is in the action letter that follows. WE ARE BEING HEARD. KEEP SENDING IN YOUR MESSAGES. We can win this!
WHAT TO DO: EMAIL THIS LETTER TO YOUR SENATORS:
You can get your Senator's info here and cut and paste the letter into their webform:
http://www.senate.gov/general/contact_i ... rs_cfm.cfm
May 2, 2007
The Honorable (Senator First and Last Name)
Address
Dear Senator Last Name;
The issue of drug safety and access to drugs at a fair price is of the utmost importance to myself and all Americans. In general, I am opposed to Senate bill S1082: Food and Drug Administration Revitalization Act, as it does not go far enough to protect myself and my family from the dangers of drugs. As one of the 150 million Americans that rely on dietary supplements to keep myself and my family well, I am especially concerned that this legislation broadens FDA regulatory power to harass functional foods and dietary supplements - which has nothing whatsoever to do with drug safety.
It is vital that the terms 'food' and 'food ingredients' be removed from this legislation. There must be no confusing the safety of drugs and the safety of food and food ingredients which are governed by different laws. This bill authorizes, on pages 106-107, the creation of a new regulatory category that enables the FDA and the Reagan-Udall Foundation for the FDA to attack dietary supplements and functional foods. This problem in the wording can be corrected with this simple amendment so as to be sure this legislation is about drugs and drug safety only.
Amendment to Bill S1082
Purpose of the amendment:
The bill, S1082: The Food and Drug Administration Revitalization Act, is hereby amended to eliminate any reference to the terms food or food ingredients, such that food and food ingredients will not be subject to any jurisdiction or control by the Regan-Udall Foundation for the Food and Drug Administration.
Intent of amendment:
To eliminate from the bill any possibility that food or food ingredients would be treated like drugs either for safety review purposes or for assessment of their efficacy. It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury.
I am in favor of the Dorgan amendment that enables Americans to get a fair price on prescription medication.
I am in favor of any Grassley amendment that offers an independent office within the FDA to monitor the safety of drugs already on the market.
I am opposed to the amendment being prepared by Durbin, as food safety is a completely different issue and must be kept out of drug safety legislation so that there can be no confusion between drug safety and food safety laws - which are quite different.
Sincerely,