Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -246

Accepted - Volume 4

Comment Record
Commentor Mrs. Pamela Ragan Date/Time 2002-07-28 20:31:58
Organization Mannataeh Inc.
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? Who has the right to say Pharmaceutical companies are the only source of consumable treatment acceptable in the USA. Isn't it our God given right to obtain another opinion? Whether that opinion be Western Medicine (as dictated by the Pharmaceutical companies), Eastern or Alternative Therapies. Where does it say that Western medicine has all the answers. Look at the records, how many diseases has Western Medicine cured? All Western medicine has achieved is to treat a disease, not cure anything. You have to be sick before your Western Medical Doctor can help you. They are not into wellness or prevention. They have no cure for anything, however they are the first in line to prevent those who may have a cure or a method of allowing the body to heal itself from educating the public. What's wrong with the Government that they would allow this to happen. Does money talk there too? Does right of way alwaya have to go to the one with the most money, trinkets, power? How about investigating those who claim there is no solution for AIDS, MS, MD, ALS etc investigate the truth. If any one of those who claim non-pharmaceutical supplements don't work had a close, loved relative even they would take the supplements to save their loved ones grief and suffering. It's because they work... Drugs kill.... Nutrients save lives! Read the literature Sugars that Cure. It's a Constitutional Right to have Freedom of Speech, however Pharmaceutical Companies are attempting to gag the public voices advocating nutritional supplementation.
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? The FDA needs to get a grip on life. A product that does not kill, mame or debilitate someone but, does help them live a more normal, pain-free, disease-free life needs to be brought to the attention of the public whether or not it happens to be produced by a pharmaceutical company. Pharmaceutical companies have gone too far on this one, there are too many prescription toxins on the market as it is. People are choosing not to see a healthcare professional rather than to have to pay for more prescribed drugs and therapies. This is quite the set up. And, now the drug companies want all over-the-counter remedies to be prescription only. That is a farce, that will push the public to self treatment without the aid of physician and other healthcare professionals. Right now, diseases are treated with drugs that may or may not bring the public to wellness. Left alone most diseases would run their own course. Persons who are ill will not seek medical advice any more nor will they become anymore compliant with prescription use. Clients have no idea of the risks involved with drugs. Alternative therapies may benefit them more than the drugs prescribed for them! I believe the FDA is guided by Pharmaceutical lobbists who are getting paid great amounts of money to convince the FDA that Pharmaceuticals are the best solution. Why then are we being poisoned by the water we drink, the food we eat and the air we breathe. Ask the toxic specialists where they dump the waste products!
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? I believe all form of supplementation should have claim validation by clinical studies and scientific research, without interference. Testimonies validated through lab, x-ray and other tests should be shared with the medical community. If someone for instance has terminal AIDS, takes supplementation and is then declared not to have AIDS, further research should be done using this substance to see if the results can be duplicated. Obviously if the results are duplicated there is some merit to the claim.
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? Disclaimers should be mandated for all products that have no scientific backing. Also, risks and adverse effects should be public knowledge. The public is entitled to make a knowledgable decision.
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? All providers of drugs, medications, nutrients supplementation and food products should be required to reveal all risk factors related to ingestion or topical use of said product.
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? There ought to be a limit to the amount of advertising done by pharmaceutical companies to get the public to ask for their product as a quick fix for any ailment known to man. Labels are advertising as well. When will the Government show latitude with use and abuse of drugs.
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? Since the FDA has no bering over non-drugs, why are we addressing supplements and food for controls? The FDA does a poor job now adding to the existing load will only make matters worse. What does the 1st Ammendment guarantee? Claims made regarding drugs are not always true, can often be misleading, and understated. Supplements aren't allowed to make medical claims. Why not, if they do what they say they do?
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? NO! Pharmaceutical companies regulate the efforts of the FDA! All others suffer.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Control drug uses! Everyone has the right of chioce. Lets honor that. The Pharmaceutical companies have chafed FDA regulations, they welcome gagging non-drug supplement companies. The Drug companies are not fully truthful now, what makes anyone think loosening restraints will benefit the consumer? Case in point, psychotropic drugs are toxic and potentially lethal, a child taking retalin may not join the armed services if the drug is taken beyond the age of 14. Retalin is a Class II drug, one step below heroin. And they are giving this to young children, who while growing up shoot guns at schools and kill fellow students. Regulate adequately toxins & drugs that kill or when mixed with other drugs kill.




EC -246