Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -4

Accepted - Volume 1

Comment Record
Commentor Ms. Cynthia Ratcliffe Date/Time 2002-05-20 11:19:23
Organization none
Category Individual

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? The truth would be sufficient with a statement of whether the product has been thru the approval process of the FDA. All ingredients should be listed, as well as all amounts and percentages of included contents of carboyhydrates, vitamins, minerals, protien, sugars, calories, etc. Promotional speech is a twisting of the truth in ways to promote a product or food, therefore is not needed. Just the facts please. Allow for fonts, sizes of text and color to be used for promotional speech only. All speech on foods and supplements should be on a level of sixth to eighth grade reading level. If a product such as a supplement is often used for a certain action, ie echineacea for antibiotic properties, then that is truth and can be stated as such. The fact that an item has not been thru the fda approval process and that the manufacturer bears all responsibility for its effects, should be sufficient for a person to know whether there is no proof product will function as it is commonly used for. If a food or item has been deemed to have caused deaths or have caused numerous problems used with another product this should be added as well as it would be a truth. One death from an allergy to a supplement or food is not significant to put on a label however an amount would have to be chosen to be included on label.
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? On prescription drugs, biologics and devices, truth of any problems must be said, or stated equally with the rest of the info. Meaning no fast talk or tiny print but the same as the rest. Advertisement leads to over prescription of drugs. On the rest I have no comment.
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? Yes consumers do approach claims about conventional foods adn dietary supplements differenty. But truth in labeling and disclaimer as to whether the item is fda approved. See number one response.
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? All disclaimers should be in equal color, text size as the rest of the information. Considering the need to be able to actually read the text in the disclaimer should be all that is needed to know that it needs to be in the same size and color. In television or radio ads the disclaimer should be said at the same speed so that they are understandable. Or provide a toll free phone number for more info.
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? Since the previous warnings on different products has not been consistant, then they should be specified that they all be specific and truthful. Excessive claims must be proven or have a statement saying they have not been thru the fda process. Consumer confusion or inattention is not something that can be regulated as long as the truth is stated without promotional speech, and in a sixth to eighth grade language.
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....freedom of speech does not mean freedom to lie and rip people off. Just the facts, and the truth presented without promotional info speech and without claims that have not been proven. A suggested use or frequency of use would be appropriate but must be truthful at all time.
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? Any and all uses of product or non use of product should be included but not required.
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? Judging by my and others purchases, the current approach seems to support the seller more than the buyer. It is not a limitation of free speech to require the truth. It is a limitation on false advertising or misleading advertising. If a seller does not feel that the truth will sell the product then that product maybe is not something that should be on the market and the public will show them that by purchasing based on truth.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Since I am unfamiliar with all the policies etc of fda I am not educated in these to comment.

EC -4