Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -406

Accepted - Volume 6

Comment Record
Commentor Ms. Christine Jolley Date/Time 2002-09-11 17:47:17
Organization Ms. Christine Jolley
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? As the drug industry is a multinational one with resources far beyond either those of the dietary supplement companies or citizens in general, there should be FDA oversight to guard against misleading advertising. Many consumers are becoming suspicious of all advertising because of the outrageous abuses of truth and the corporate greed that is rampant in today's world. Even information to learned intermediaries should be restricted unless pro/con arguments are available to them.
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 personally do my own research on any drug my doctor has recommended and often, do not follow her request. I have found over the years that my feedback about symptoms never reaches the FDA and responsibility for the drugs' side effects is never taken by the drug industry or the medical industry (i.e. birth control pills, IUDs, etc. in the early days). Class action lawsuits only limit the liability of corporations as we gave them Constitutional Rights that were originally designated for human beings. Unbridled capitalism is battering Democracy and average citizens like myself are doing our individual best to change the tide.
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? The pros and cons of dietary supplements should be contained with any distribution, including alternative theories as we are in the infant stages of understanding the complex interactions of food, supplements, pollutants, etc. on our bodies.
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? To regain the trust of the American people, I would say yes. I have been in the social science field for the last twenty years and have learned much about power abuse. Anyone with power of knowledge, resources, or destruction capability needs to be held accountable for their use/abuse of that power. The world destroys itself when each one is not. We seem to be in a free fall descent currently.
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? I read the contents and warnings on all that I consume. I go to the Internet as I have found less biased information there than from my pharmacist, doctor, government or major media sources.
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? Studies done without competing biases should not be accepted as proof, regardless of the expertise of the learned institutions.
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? Allowing free speech to profit-oriented marketers deprives the consumer of adequate information for maintaining or improving their health. Nameless individuals within corporations hide themselves and their selfish intents with their huge resources. Hopefully, the FDA will not take one more step down that slippery slope by granting them more personhood rights.




EC -406