Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -218

Accepted - Volume 4

Comment Record
Commentor Ms. Patricia Nellans Date/Time 2002-07-26 12:49:50
Organization Ms. Patricia Nellans
Category Health Professional

Comments for FDA General
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? IN NO WAY, ABRIDGE MY RIGHT TO INFORMATION ABOUT NUTRITIONAL PRODUCTS!!! WHY WOULD THE FDA WANT TO DO THIS? Especially since drug advertisement to the general public is rampantly unregulated. The deal is: as long as the drug cartels state all the side effects, they can use the media to sell their products. These drugs have many adverse side effects; nutritional supplements for the most part DO NOT. Additionally, the lopsided approach presented to doctors, ie, drugs vrs nutritionals, is inherently misleading and to me. Physicians should receive as much training in nutritional approaches to diseases as drug approaches to diseases: THIS SHOULD BE MANDATORY. Drug companies have unbelievable entree to the physicians after medical school; just how much money do the drug companies spend luring doctors to prescribe their pills. If you want to regulate something, regulate that. TAKE A PAGE FROM EUROPE, ESPECIALLY, GERMANY!!! Their people are healthier and don't have an FDA colluding with the drug companies to promote drugs and limit nutritionals under the guise of protecting its citizens. LEAVE THE NUTRITIONAL INDUSTRY ALONE; by comparison, the harm done by nutritionals is tiny compared with the harm done by drugs!
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? Direct consumer advertisement of drugs leads to over prescription of drugs and requests by patients. THIS DOES NOT APPLY IN MY MIND TO NUTRICEUDICALS. DO NOT LIMIT THE INFORMATION ON NUTRICEUDICALS; THEY ARE THE HOPE FOR THE FUTURE!! I understand this is not in the best interest of the drug companies, but IT IS IN THE BEST INTEREST OF THE CITIZENS OF THE UNITED STATES!!!
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? Why does the FDA want to limit in any way info about dietary supplements? Are they indeed in bed with the powerful drug company lobbies? LEAVE THE DIETARY SUPPLEMENT INDUSTRY ALONE!!! I CAN BE NO CLEARER. Since many drugs are synthesized versions of natural substances, and the drugs have side effects and the natural substances usually DO NOT: The only reason I can see that FDA wants to regulate is being too closely related with the drug companies. DO NOT AMMEND MY FREEDOM OF CHOICE!
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 large enough for the elder population to read without glasses!
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? When a drug is advertised on television, also include how many people have died; how many have had life threatening problems associated with the drug. NOT, just that this or that can happen; publish the numbers! I have no problem with doing the same for nutritionals.
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? NO! What has happened in the past is no drug I have ever received has warnings on the label. You have to go to the pharmacist---the doctor rarely knows and will only look it up when requested and then has no idea how many have problems, etc. If you want to focus attention where it is needed, focus on the drug industry and their gross misrepresentations. STOP ALL MONEY CONNECTIONS between the FDA and drug companies.
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? FDA is supposed to regulate drugs NOT nutritionals. Keep out of business that isn't yours and regulate the industry you are supposed to regulate. This question is inherently unclear. If you are speaking of drugs, the FDA should look at them before manufacturer makes claims. If you are speaking of nutritionals, ABSOLUTELY NOT!!!! The FDA needs to keep its nose out of the nutritional industry; you are not an unbiased agent. Too many of your people have worked in the drug industries; you are biased. This is just another ploy to limit nutritionals so the drug companies can take over and make money. THEY KNOW that their only hope of survival is to take over the nutritional industry so they can make hugh amts of money by prescribing food for people. NO,NO,NO and a thousand times NO. Do not apply this to nutritionals!!!
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? FDA needs to look at a better more efficient model for the whole drug approval business. It appears to me, the drug companies have and always have had FREEDOM of speech. You have tried to regulate the nutritional industry, not to protect people, but to help the drug companies. Whatever, you do, DO NOT limit the right of nutritional supplements to state what these supplements do for health!!!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Allow, nutritionals the same freedom you have given the drug companies. STOP trying to regulate the nutritional, ie food, industry. If you want to regulate something, stop the genetic engineering of food until we know all the possible problems associated with it. LIMIT the close association between drug companies and physicians----when I go to a physician who has been indoctrinated by the drug companies, my freedom of health is limited. I can't even get my nutritionals paid for by insurance; nutritionals are cheaper and usually without side effects. Is this freedom of speech limitation, probably not; it's more like limitation of overall freedom. If there are any regs you need to tighten, its limiting the drug companies access to medical schools and doctors----doctors are for the most part so brain washed, they don't even know alternatives are available. The FDA has a choice, lead the way to a better way, or support the old ways and limit the freedom of every citizen in this country.

EC -218