Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -408

Accepted - Volume 6

Comment Record
Commentor Ms. Judith Merrill-Smith Date/Time 2002-09-11 18:15:34
Organization Ms. Judith Merrill-Smith
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 FDA must first and foremost be concerned with public health. Pharmaceutical drugs are usually more potent/stronger/more dangerous if misused than dietary supplements, thus stronger regulations of speech about drugs only makes sense. I feel this is especially true of speech directed at consumers, who have less background training and knowledge than intermediaries (doctors, pharmacists, etc.).
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? Allowing drug companies to hype their wares to consumers sets a standard of medical practice that says prescription drugs are the answer to your every medical problem. If your doctor doesn't prescribe our drug for your problem, she is ignoring our great research and the best treatment that's out there. There is usually little mention of things that need to be done in addition to using the drug, let alone any thought that maybe a drug is NOT the answer and that your medical team might have other options for you (the patient). This seems particularly insidious when we talk about drug campaigns aimed at parents of children.
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 do not think that most consumers look to conventional foods to cure their ills. But the minute you put a powder in a capsule, it starts to look like a drug and people seem to be a bit more leery about what they are swallowing. Health claims on food labels are ignored more frequently than claims on supplements, I believe. However, it is important that claims on either product be backed by reasonable evidence (peer-reviewed, empirical research that has been replicated), that the claims are made simply, clearly, and that any disclaimers or qualifiers must be made just as simple and clear.
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 must be easy to find (preferably just below the claim) and should be no more than one point size smaller than the claim. If you want people to read them, they have to be available!
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? The FDA needs to balance the rights of the individual in this society with the rights of corporations. Frankly, corporations have the upper hand in this society and do not need further help from government in plying their wares. Speech for corporations is advertising -- it is not education for the greater public good. Government needs to be an intermediary between the powerful (who would dictate what everyone buys) and the average citizen (who does not have enough hours in a day or resources to make truly informed purchasing decisions as it is).

EC -408