Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -424

Accepted - Volume 6

Comment Record
Commentor Ms. Shirley Bortner Date/Time 2002-09-13 16:37:03
Organization Association of Food and Drug Officials
Category Association

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? There is not a clear line of demarcation between drugs and some highly purified extracts of plant components that are sold as dietary supplements. Many prescription drugs began their life as a plant component and many of these components that become drugs, such as tamoxifen for example, have dangerous side effects if their use is not prescribed and monitored by a physician. For prescription drugs, the doctor and pharmacist serve as gatekeepers for evaluating information as to the characteristics of the drug, including its appropriate use and risks. If these drugs are marketed through advertising directly to consumers, full disclosure of pertinent information for safe and efficacious use of the drugs, including warnings and contraindications, is required through appropriate regulations governing such advertisements. There is, however, no gatekeeper for dietary supplements and the FDA label requirements should become that gatekeeper in a fashion similar to over-the-counter (OTC) drugs. For the safe and efficacious use of dietary supplements, FDA must regulate the use, labeling and advertising, such as active ingredient strength, ingredients, appropriate warnings, contraindications and adverse events, as is currently required for OTC drugs and prescription drugs FDA should especially consider increased regulation of commercial speech for dietary supplements that are concentrated, refined extracts more in line with OTC label requirements as opposed to those supplements that are in their natural state with lower, naturally occurring active ingredient strengths. The concentrated forms frequently represent greater need for disclosure with respect to contraindications and adverse event warnings and other information for safe and efficacious use. It should be noted that currently the FDA does not regulate the commercial speech or advertising for dietary supplements in a manner that ensures safety for the consumers with respect to contraindications and warning statements on dietary supplements.
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? Manufacturers that do direct-to-consumer advertising have met different standards for their products. They have had to establish and prove safety and effectiveness for their products, unlike pharmacists that are compounding and/or manufacturing products and then advertising them to practitioners and consumers. Also, advertisements/promotions cross international boundaries creating problems for Mexico and Canada specifically. Negative effects are persons self diagnosing and buying these drugs over the Internet or in foreign countries with no medical oversight. They also demand certain drugs from their physician which interferes with the judgment of the physician. Positive effects are persons are better informed on the array of drugs available for various conditions.
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? AFDO believes that FDA must do this based on the fact that by definition, dietary supplements may be concentrated extracts of plant products with significant biological activity and impact—a fact that is not true of traditional foods. Such information can be provided in tabular form and/or in concise messages regarding any public health concern that is present or that consumers need to know to evaluate appropriate and safe use prior to product purchase. AFDO believes that a significant number of consumers approach dietary supplements as alternatives to therapy by drugs. Therefore, there is a basis to approach dietary supplement and conventional foods somewhat differently.
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? It would be advisable to utilize a consumer focus group that includes a cross section of potential users—particularly senior citizens—to determine the need for qualifiers and/or disclaimers. Need for the use of disclaimers should be minimized. Type size should be sufficient to provide the information and any qualifier so that one does not take precedent over the other. Some research may be available from the Federal Trade Commission gathered as a result of advertising-impact investigations.
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? AFDO believes the OTC drug monographs provide a good template for consumer information on warning statements. Clear concise warning in plain English and in a reasonable type size for age and/or other impaired sight is needed. In other words, it has to be easily readable and understandable by the intended consumer. Another effective method is similar to standardized panels found on foods pursuant to the Nutritional Labeling and Education Act and the panels on OTC drugs.
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? None, AFDO believes that because advertising is frequently done in “sound bites”, whereas labeling stays with the product, there is a strong need to control advertising to the same degree as labeling with respect to information, except directions for use which should be clearly defined on the label. The FDA, as gatekeeper for the safety and health-education of citizens, has a strong role to play with both labels and advertising. Advertising is labeling of the product.
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? To begin with, most distributors and marketers have no knowledge, training, or licensure that qualifies them to provide information regarding off-label uses. Off-label uses to be recommended to consumers not only undermines the FDA’s authority, but also would serve to encourage abuse--possibly dangerous abuse of products. Off-label use speech should be limited to physicians who must then assume liability for the consequences of any off label prescribing.
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? YES! Alternative approaches would undermine the very purpose and essence of the Federal Food, Drug and Cosmetic Act that serves to protect public health and ensure consumers of accurate and truthful information that is not misleading in any particular. One of the basic powers of government is to protect public health and well-being and this Act is a cornerstone to fulfilling that role.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Regulation under the original Pure Food Act and the Food Drug and Cosmetic Act has provided almost 100 years of gold-standard regulation of foods and drugs. AFDO favors giving FDA full support for effective enforcement of these requirements through increased resources to the agency. This is particularly true in the areas where FDA has had to “back off” because of lack of resources.

EC -424