Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -95

Accepted - Volume 2

Comment Record
Commentor Mr. David James Date/Time 2002-06-01 08:40:40
Organization Action Air
Category Company

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? 1a - Of course, but any argument must have foundation.(not well worded question) 1b - An administrative record must contain FACTS that refute the claim or argument, or else the FDA is merely another empty voice in the wind. 1c - Yes, but FDA's position regarding promotional speech has done little to change anything since FDA's creation. FDA must not have any power to regulate promotional speech, but it must take a position on whether speech regarding drugs is misleading. There must not be requirements by the FDA. Requirements have done little or nothing in the past to prevent the millions of illnesses and death caused by prescription drugs. This is one reason why FDA's requirements are nothing more than intrusive as it relates to private business and privacy of the individual and his choices. FDA must get out of the requirement business and act as an advisory service, since all of the requirements of FDA have done nothing to stem the damage done to millions by legal drugs over the years. 1d - No. FDA must not be allowed to be placed in a position where it CONTROLS speech. FDA can warn the public pursuant to what the FDA KNOWS FOR FACT, AND NOT WHAT IT SUSPECTS OR BELIEVES. 1e - None.
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? 2a - This is a ridiculous question. How can anyone that is not involved in research actually answer this question? Are there more than one or two people in the country that can answer such a question honestly after having attained knowledge, statistics, facts, etc. 2b - Too numerous for discussion and it is not even relevant to the discussion of FDA's authority. 2c - Current regulatory approach has muddled the entire process of citizens finding what works best for them, and yes this regulatory approach does cause over prescription because people continue request their doctors to prescribe something better, leading to massive personal over-expenditures for drugs that sit in the medicine cabinet when they are found to be of no postive effect. 2d - Nobody knows the answers to the rest of the questions in this section. Again, FDA must not REGULATE but rather ADVISE on the basis of accumulated data. FDA must not regulate what is said about a product especially when the regulation is not based upon actual data. FDA has no business stating anything more than claims made for or against this product have not been substantiated by the by the FDA, unless FDA has absolute proof through empirical data and research, one way or the other.
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? FDA can only be allowed to distinguish claims made on or between foods and/or supplements, based upon proof established through actual data and valid research. Nothing more. FDA is getting too involved with attempting to save the world, when it must limit itself to an advisory position. Again, the FDA has done nothing to stem the tide regarding more than 100,000 deaths per year from drug reactions etc. and many more illnesses caused by drug reactions. FDA has merely confused the issues when it should be quiet on subjects it does not have ABSOLUTE PROOF AND/OR KNOWLEDGE ABOUT. It is possible that FDA's involvement in drugs and prescriptions has had an immensely greater negative effect on safety than positive.
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? Buyer beware. This is true with any product. It is impossible to say what size type and the degree of prominence is necessary. Therefore, FDA should not even attempt to regulate this either, since it would be proceeding on the basis of somebody's concepts! This is hardly the way to create requirements, yet this is exactly what government has become popular for doing. FDA must stay out of the disclaimer requirement business altogether because it cannot possibly do any good without knowing both sides of the story with absolute certainty.
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? FDA must not be concerned with anything other than established FACT.
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? Government has failed to protect people to any great degree with all of its regulatory power over the years, and very probably has caused more damage to the public through favoritism toward lobbied interests. It is impossible for government to control any speech in a positive manner and government must not even consider doing so since it has no absolutes to guide it, any more than any person or entity does.
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 must not have ability to regulate speech in any manner. This is not authority given to FDA by the People. The FDA is not a parent that has authority OVER THE PEOPLE. It is an advisory agency ONLY that should accumulate data and be able to advise the public on what it has learned ONLY. Leave private enterprise alone and let each business stand or fall on its own abilities to produce good products and let business stand on its own reputation as this has worked for centuries.
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? ABSOLUTELY NOT! FDA must pursue objectives of accumulating information and disseminating information ONLY. Restrictions have proven to be more damaging to the public, because the FDA and other agencies always go off half cocked and warn and regulate on the basis of half-cocked ideas and concepts.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? YES. FDA is a servant of the people, not its tyrannical master. FDA must stay out of the regulation business and stop attempting to protect people through force! Guidance through dissemination of SOLID information is the answer, not regulation. FDA should never have even been placed in the position of having to defend itself regarding the First Amendment issue. This litigation is proof that FDA has overstepped its bounds as an advisory service rather than a regulator over private business and private choices!

EC -95