Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -203

Accepted - Volume 4

Comment Record
Commentor Mr. Wesley Flanary Date/Time 2002-07-26 01:22:21
Organization Mr. Wesley Flanary
Category Individual

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? All drugs are considered to be toxic, and most dietary supplements are not toxic. I feel like these speech regulations should mainly focus on drugs and drug manufacturers, on the other hand if a manufacturer can prove through scientific research that its products are not considered to be toxic, and can prove its efficacy then the above mentioned speech regulations should not apply.
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? I feel like FDA needs to crack down on how much these drug companies can advertise a certain drug. These drug companies commercials on television make you feel like this drug that they are offering is the best, and is the only soloution you have to your sickness or whatever condition you may have. They make you think if you get this drug you will feel so much better and all is well. That is wrong and misleading. When in fact, the side effects of most drugs are actually more harmful than the disease or illness you may have. And in reality by taking such and such drug for a certain condition or disease, you can possibly have more serious health conditions as a result of taking this drug. I feel like Food and Dietary Supplement Companies need to be able to advertise and make true claims to their products as well especially the companies that can prove through science and research and through studies that their products are just as much effective, if not more effective as drugs. The PUBLIC needs to be aware, and is their right, to know about other companies such as dietary supplement and food companies that have Scientifically based products for their certain disease or condition as well, and not just drug companies.
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 feel like if there is a drug, dietary supplement, food or whatever it is, if it can be proven through scientific research and validation and with case studies been conducted and after all of this is over if it is determined that such and such is a successful treatment or cure for certain disease or conditions, then I feel like that is what needs to be on the label. People could care less about a label that reads this product has not evaluated by the FDA and is not intended for a treatment or cure any disease. Let me tell you what I think all of this label garbage is about, I feel like the government is afraid some Dietary Supplement Company is going to find a treatment or a cure for a certain disease such as cancer, before these big drug companies do and certain individuals are not going to get their pockets lined with money.
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? I feel like the truth needs to be told about drugs and dietary supplpements regardless how big or small the disclaimers are. To me the size of letters on a disclaimer is not going to make any difference. Most people do not even read the labels on what they are even taking. If the desire to take a certain medication is there then that person is going to take it, if not then they want.
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? Maybe you can add a phone number of the company who manufactured the product to where people can call with their questions or concerns about this product and maybe information to where that individual can obtain copies of actual studies that have been done regarding this product. Kind of like a hot-line.
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? I feel like if the Government really cared about the health of its citizens it would crack down on other health issues such as pollution, pesticides, chemicals, just to name a few. I feel like this label issue is just to protect the FDA from getting its but from being sued.
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? I say if a company can prove their products are effective as a treatment or cure for a disease or condition, regardless if it is a drug or a food or a dietary supplement then what does it matter what claime are made as long as their claims are supported by scientific validation and is proven to be effective. What does it matter, the claims are not hurting anyone.
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. I think guidelines and product labeling are to be for those companies that cannot back their claims with scientific validation and strict penalties imposed upon them. I believe this would weed out the Bad companies trying to make a quick buck and would punish those who make false claims. Never punish someone for doing good. If a company (drug or dietary supplement) can prove the efficacy of its products then let them make true claims about their products and don't put limitations on what they can say.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I feel like the FDA needs to put more regulations on drug companies concerning how safe these drugs really are. Last year there were over 100,000 deaths due to drug reactions. I'm not talking about drugs reacting with other drugs I'm talking drugs that reacted within people's bodies and the first symptom they had was death. Drugs that you the FDA approved and drugs that were prescribed by physicians. Know wonder more and more people are going to alternative medicine and dietary supplements. Leave the Dietary Supplement Health and Education Act of 1994 alone. Let the people decide what is best for them and not what the Government says is good for them.




EC -203