Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -261

Accepted - Volume 4

Comment Record
Commentor Mrs. Lynda Wallin Date/Time 2002-07-29 13:34:58
Organization Mrs. Lynda Wallin
Category Health Professional

Comments for FDA General
Questions
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? Let us not get into the constitutionality of the FDA's agencies or the benifits of their existence, the fact is that the FDA has overstepped its regulatory bounds by enforcing misguided disclaimer at all. One can only see that the AMA(American Medical Association), the various pharmaceutical companies, and the Insurance industry has large and powerful lobbying groups to support their positions, be it in the best interest of the population or not, and that they have a very strong hold on how the Health Care Industry is managed in this country as well as, how it is managed in other countries. This is in part a fact that other countries look to the USA for many of their public/government programs as we have been looked upon as the most advanced in many technical, medical, and political world, examples of a few. False claims have come from all of these industries, stated above, with regards to the Federal Trade Commission. The FDA's mandate is to evaluate the safety and the efficacy or products for consumers of pharmaceuticals, foods, cosmetics, and other products. So, who really does it protect when it takes the less than necessary steps of requiring labels to carry this disclaimer? Labels on pharmaceuticals do not say that this has met the LD50 test so if you take enough of it that one of the side effects you will have will be death. No it doesn't say that and the explanations to consumers from physicians prescribing medications put out by the pharmaceutical groups don't tell their patients that medications, when taking more than 2 or more different medications at a time, have not been studied and researched for their adverse effects or their benefits, or if they will counteract the effects of the each other. So how can the FDA want to further regulate something that pharmaceutical companies have researched and found that they have profound and beneficial results for the consumer, and are trying to make synthetic drugs from this research but are unable to because the only place to get the product is through natural, plant based means. Power is money and money is power, and that is what the three entities, as stated earlier in this paragraph have and want to try to hold onto to no matter what battle they pick. Let consumers be responsible for themselves and to find out what will work for them when educated in a means that they can understand. All research material, and other responsible means of educating the public in a ethical way should be allowed to be shared with the public so that they can make educated, and informed decisions about their own bodies, minds, and spirits.
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? Let us not get into the constitutionality of the FDA's agencies or the benifits of their existence, the fact is that the FDA has overstepped its regulatory bounds by enforcing misguided disclaimer at all. One can only see that the AMA(American Medical Association), the various pharmaceutical companies, and the Insurance industry has large and powerful lobbying groups to support their positions, be it in the best interest of the population or not, and that they have a very strong hold on how the Health Care Industry is managed in this country as well as, how it is managed in other countries. This is in part a fact that other countries look to the USA for many of their public/government programs as we have been looked upon as the most advanced in many technical, medical, and political world, examples of a few. False claims have come from all of these industries, stated above, with regards to the Federal Trade Commission. The FDA's mandate is to evaluate the safety and the efficacy or products for consumers of pharmaceuticals, foods, cosmetics, and other products. So, who really does it protect when it takes the less than necessary steps of requiring labels to carry this disclaimer? Labels on pharmaceuticals do not say that this has met the LD50 test so if you take enough of it that one of the side effects you will have will be death. No it doesn't say that and the explanations to consumers from physicians prescribing medications put out by the pharmaceutical groups don't tell their patients that medications, when taking more than 2 or more different medications at a time, have not been studied and researched for their adverse effects or their benefits, or if they will counteract the effects of the each other. So how can the FDA want to further regulate something that pharmaceutical companies have researched and found that they have profound and beneficial results for the consumer, and are trying to make synthetic drugs from this research but are unable to because the only place to get the product is through natural, plant based means. Power is money and money is power, and that is what the three entities, as stated earlier in this paragraph have and want to try to hold onto to no matter what battle they pick. Let consumers be responsible for themselves and to find out what will work for them when educated in a means that they can understand. All research material, and other responsible means of educating the public in a ethical way should be allowed to be shared with the public so that they can make educated, and informed decisions about their own bodies, minds, and spirits.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? Let us not get into the constitutionality of the FDA's agencies or the benifits of their existence, the fact is that the FDA has overstepped its regulatory bounds by enforcing misguided disclaimer at all. One can only see that the AMA(American Medical Association), the various pharmaceutical companies, and the Insurance industry has large and powerful lobbying groups to support their positions, be it in the best interest of the population or not, and that they have a very strong hold on how the Health Care Industry is managed in this country as well as, how it is managed in other countries. This is in part a fact that other countries look to the USA for many of their public/government programs as we have been looked upon as the most advanced in many technical, medical, and political world, examples of a few. False claims have come from all of these industries, stated above, with regards to the Federal Trade Commission. The FDA's mandate is to evaluate the safety and the efficacy or products for consumers of pharmaceuticals, foods, cosmetics, and other products. So, who really does it protect when it takes the less than necessary steps of requiring labels to carry this disclaimer? Labels on pharmaceuticals do not say that this has met the LD50 test so if you take enough of it that one of the side effects you will have will be death. No it doesn't say that and the explanations to consumers from physicians prescribing medications put out by the pharmaceutical groups don't tell their patients that medications, when taking more than 2 or more different medications at a time, have not been studied and researched for their adverse effects or their benefits, or if they will counteract the effects of the each other. So how can the FDA want to further regulate something that pharmaceutical companies have researched and found that they have profound and beneficial results for the consumer, and are trying to make synthetic drugs from this research but are unable to because the only place to get the product is through natural, plant based means. Power is money and money is power, and that is what the three entities, as stated earlier in this paragraph have and want to try to hold onto to no matter what battle they pick. Let consumers be responsible for themselves and to find out what will work for them when educated in a means that they can understand. All research material, and other responsible means of educating the public in a ethical way should be allowed to be shared with the public so that they can make educated, and informed decisions about their own bodies, minds, and spirits.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? Let us not get into the constitutionality of the FDA's agencies or the benifits of their existence, the fact is that the FDA has overstepped its regulatory bounds by enforcing misguided disclaimer at all. One can only see that the AMA(American Medical Association), the various pharmaceutical companies, and the Insurance industry has large and powerful lobbying groups to support their positions, be it in the best interest of the population or not, and that they have a very strong hold on how the Health Care Industry is managed in this country as well as, how it is managed in other countries. This is in part a fact that other countries look to the USA for many of their public/government programs as we have been looked upon as the most advanced in many technical, medical, and political world, examples of a few. False claims have come from all of these industries, stated above, with regards to the Federal Trade Commission. The FDA's mandate is to evaluate the safety and the efficacy or products for consumers of pharmaceuticals, foods, cosmetics, and other products. So, who really does it protect when it takes the less than necessary steps of requiring labels to carry this disclaimer? Labels on pharmaceuticals do not say that this has met the LD50 test so if you take enough of it that one of the side effects you will have will be death. No it doesn't say that and the explanations to consumers from physicians prescribing medications put out by the pharmaceutical groups don't tell their patients that medications, when taking more than 2 or more different medications at a time, have not been studied and researched for their adverse effects or their benefits, or if they will counteract the effects of the each other. So how can the FDA want to further regulate something that pharmaceutical companies have researched and found that they have profound and beneficial results for the consumer, and are trying to make synthetic drugs from this research but are unable to because the only place to get the product is through natural, plant based means. Power is money and money is power, and that is what the three entities, as stated earlier in this paragraph have and want to try to hold onto to no matter what battle they pick. Let consumers be responsible for themselves and to find out what will work for them when educated in a means that they can understand. All research material, and other responsible means of educating the public in a ethical way should be allowed to be shared with the public so that they can make educated, and informed decisions about their own bodies, minds, and spirits.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? Let us not get into the constitutionality of the FDA's agencies or the benifits of their existence, the fact is that the FDA has overstepped its regulatory bounds by enforcing misguided disclaimer at all. One can only see that the AMA(American Medical Association), the various pharmaceutical companies, and the Insurance industry has large and powerful lobbying groups to support their positions, be it in the best interest of the population or not, and that they have a very strong hold on how the Health Care Industry is managed in this country as well as, how it is managed in other countries. This is in part a fact that other countries look to the USA for many of their public/government programs as we have been looked upon as the most advanced in many technical, medical, and political world, examples of a few. False claims have come from all of these industries, stated above, with regards to the Federal Trade Commission. The FDA's mandate is to evaluate the safety and the efficacy or products for consumers of pharmaceuticals, foods, cosmetics, and other products. So, who really does it protect when it takes the less than necessary steps of requiring labels to carry this disclaimer? Labels on pharmaceuticals do not say that this has met the LD50 test so if you take enough of it that one of the side effects you will have will be death. No it doesn't say that and the explanations to consumers from physicians prescribing medications put out by the pharmaceutical groups don't tell their patients that medications, when taking more than 2 or more different medications at a time, have not been studied and researched for their adverse effects or their benefits, or if they will counteract the effects of the each other. So how can the FDA want to further regulate something that pharmaceutical companies have researched and found that they have profound and beneficial results for the consumer, and are trying to make synthetic drugs from this research but are unable to because the only place to get the product is through natural, plant based means. Power is money and money is power, and that is what the three entities, as stated earlier in this paragraph have and want to try to hold onto to no matter what battle they pick. Let consumers be responsible for themselves and to find out what will work for them when educated in a means that they can understand. All research material, and other responsible means of educating the public in a ethical way should be allowed to be shared with the public so that they can make educated, and informed decisions about their own bodies, minds, and spirits.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? Let us not get into the constitutionality of the FDA's agencies or the benifits of their existence, the fact is that the FDA has overstepped its regulatory bounds by enforcing misguided disclaimer at all. One can only see that the AMA(American Medical Association), the various pharmaceutical companies, and the Insurance industry has large and powerful lobbying groups to support their positions, be it in the best interest of the population or not, and that they have a very strong hold on how the Health Care Industry is managed in this country as well as, how it is managed in other countries. This is in part a fact that other countries look to the USA for many of their public/government programs as we have been looked upon as the most advanced in many technical, medical, and political world, examples of a few. False claims have come from all of these industries, stated above, with regards to the Federal Trade Commission. The FDA's mandate is to evaluate the safety and the efficacy or products for consumers of pharmaceuticals, foods, cosmetics, and other products. So, who really does it protect when it takes the less than necessary steps of requiring labels to carry this disclaimer? Labels on pharmaceuticals do not say that this has met the LD50 test so if you take enough of it that one of the side effects you will have will be death. No it doesn't say that and the explanations to consumers from physicians prescribing medications put out by the pharmaceutical groups don't tell their patients that medications, when taking more than 2 or more different medications at a time, have not been studied and researched for their adverse effects or their benefits, or if they will counteract the effects of the each other. So how can the FDA want to further regulate something that pharmaceutical companies have researched and found that they have profound and beneficial results for the consumer, and are trying to make synthetic drugs from this research but are unable to because the only place to get the product is through natural, plant based means. Power is money and money is power, and that is what the three entities, as stated earlier in this paragraph have and want to try to hold onto to no matter what battle they pick. Let consumers be responsible for themselves and to find out what will work for them when educated in a means that they can understand. All research material, and other responsible means of educating the public in a ethical way should be allowed to be shared with the public so that they can make educated, and informed decisions about their own bodies, minds, and spirits.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? Let us not get into the constitutionality of the FDA's agencies or the benifits of their existence, the fact is that the FDA has overstepped its regulatory bounds by enforcing misguided disclaimer at all. One can only see that the AMA(American Medical Association), the various pharmaceutical companies, and the Insurance industry has large and powerful lobbying groups to support their positions, be it in the best interest of the population or not, and that they have a very strong hold on how the Health Care Industry is managed in this country as well as, how it is managed in other countries. This is in part a fact that other countries look to the USA for many of their public/government programs as we have been looked upon as the most advanced in many technical, medical, and political world, examples of a few. False claims have come from all of these industries, stated above, with regards to the Federal Trade Commission. The FDA's mandate is to evaluate the safety and the efficacy or products for consumers of pharmaceuticals, foods, cosmetics, and other products. So, who really does it protect when it takes the less than necessary steps of requiring labels to carry this disclaimer? Labels on pharmaceuticals do not say that this has met the LD50 test so if you take enough of it that one of the side effects you will have will be death. No it doesn't say that and the explanations to consumers from physicians prescribing medications put out by the pharmaceutical groups don't tell their patients that medications, when taking more than 2 or more different medications at a time, have not been studied and researched for their adverse effects or their benefits, or if they will counteract the effects of the each other. So how can the FDA want to further regulate something that pharmaceutical companies have researched and found that they have profound and beneficial results for the consumer, and are trying to make synthetic drugs from this research but are unable to because the only place to get the product is through natural, plant based means. Power is money and money is power, and that is what the three entities, as stated earlier in this paragraph have and want to try to hold onto to no matter what battle they pick. Let consumers be responsible for themselves and to find out what will work for them when educated in a means that they can understand. All research material, and other responsible means of educating the public in a ethical way should be allowed to be shared with the public so that they can make educated, and informed decisions about their own bodies, minds, and spirits.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? Let us not get into the constitutionality of the FDA's agencies or the benifits of their existence, the fact is that the FDA has overstepped its regulatory bounds by enforcing misguided disclaimer at all. One can only see that the AMA(American Medical Association), the various pharmaceutical companies, and the Insurance industry has large and powerful lobbying groups to support their positions, be it in the best interest of the population or not, and that they have a very strong hold on how the Health Care Industry is managed in this country as well as, how it is managed in other countries. This is in part a fact that other countries look to the USA for many of their public/government programs as we have been looked upon as the most advanced in many technical, medical, and political world, examples of a few. False claims have come from all of these industries, stated above, with regards to the Federal Trade Commission. The FDA's mandate is to evaluate the safety and the efficacy or products for consumers of pharmaceuticals, foods, cosmetics, and other products. So, who really does it protect when it takes the less than necessary steps of requiring labels to carry this disclaimer? Labels on pharmaceuticals do not say that this has met the LD50 test so if you take enough of it that one of the side effects you will have will be death. No it doesn't say that and the explanations to consumers from physicians prescribing medications put out by the pharmaceutical groups don't tell their patients that medications, when taking more than 2 or more different medications at a time, have not been studied and researched for their adverse effects or their benefits, or if they will counteract the effects of the each other. So how can the FDA want to further regulate something that pharmaceutical companies have researched and found that they have profound and beneficial results for the consumer, and are trying to make synthetic drugs from this research but are unable to because the only place to get the product is through natural, plant based means. Power is money and money is power, and that is what the three entities, as stated earlier in this paragraph have and want to try to hold onto to no matter what battle they pick. Let consumers be responsible for themselves and to find out what will work for them when educated in a means that they can understand. All research material, and other responsible means of educating the public in a ethical way should be allowed to be shared with the public so that they can make educated, and informed decisions about their own bodies, minds, and spirits.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Let us not get into the constitutionality of the FDA's agencies or the benifits of their existence, the fact is that the FDA has overstepped its regulatory bounds by enforcing misguided disclaimer at all. One can only see that the AMA(American Medical Association), the various pharmaceutical companies, and the Insurance industry has large and powerful lobbying groups to support their positions, be it in the best interest of the population or not, and that they have a very strong hold on how the Health Care Industry is managed in this country as well as, how it is managed in other countries. This is in part a fact that other countries look to the USA for many of their public/government programs as we have been looked upon as the most advanced in many technical, medical, and political world, examples of a few. False claims have come from all of these industries, stated above, with regards to the Federal Trade Commission. The FDA's mandate is to evaluate the safety and the efficacy or products for consumers of pharmaceuticals, foods, cosmetics, and other products. So, who really does it protect when it takes the less than necessary steps of requiring labels to carry this disclaimer? Labels on pharmaceuticals do not say that this has met the LD50 test so if you take enough of it that one of the side effects you will have will be death. No it doesn't say that and the explanations to consumers from physicians prescribing medications put out by the pharmaceutical groups don't tell their patients that medications, when taking more than 2 or more different medications at a time, have not been studied and researched for their adverse effects or their benefits, or if they will counteract the effects of the each other. So how can the FDA want to further regulate something that pharmaceutical companies have researched and found that they have profound and beneficial results for the consumer, and are trying to make synthetic drugs from this research but are unable to because the only place to get the product is through natural, plant based means. Power is money and money is power, and that is what the three entities, as stated earlier in this paragraph have and want to try to hold onto to no matter what battle they pick. Let consumers be responsible for themselves and to find out what will work for them when educated in a means that they can understand. All research material, and other responsible means of educating the public in a ethical way should be allowed to be shared with the public so that they can make educated, and informed decisions about their own bodies, minds, and spirits.




EC -261