Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -115

Accepted - Volume 2

Comment Record
Commentor Mrs. Connie du Toit Date/Time 2002-06-05 10:33:03
Organization Mrs. Connie du Toit
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? There are no legitimate arguments for the regulation of speech, especially by a branch of the U.S. Government. All government agencies are sworn to protect and uphold the U.S. Constitution and even a minor appearance of a First Amendment violation makes traitors and liars out of the officials who champion such causes. If a company advertises or promotes a product, the burden is with the free market, not the government, to bring suit if the claims are false or misleading. THE PEOPLE do not need to be protected from private industry, we're fully capable of protecting ourselves.
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? The FDA should not be spending tax payer money to conduct such research so the entire argument is meaningless. A consumer is responsible for what they do and for verifying or educating themselves on the products and services they acquire. If a product has been approved by the FDA then let the buyer beware.
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? Regulating the food industry and requiring labels on products is another intrusive regulation on private industry. Let the market decide. If consumers want product labeling, let them send that message with their dollars to the companies who provide product labels.
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? Again, let the buyer beware. If a company falsely advertises their product, the consumer has the option of filing a lawsuit against the company. There is no need for intrusive government regulation to protect us.
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? Warnings are unnecessary and are beyond the scope and responsibilities of the government.
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? The very reason the Founding Fathers articulated first the right of Free Speech was because history taught us that it is the first right that an intrusive government tries to prohibit. The government has no right, for any reason, to interfere with an individual or a company's right to free speech. If that speech is later determined to be slanderous or dangerous, it is up to the individual harmed to bring suit. The government does not need to take premptive measures to protect consumers.
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? No. The FDA should not be regulating speech PERIOD.
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's speech regulations are a violation of our First Amendment rights. There is no legitimate argument for a government agency to infringe on the rights of the people and those who put forth such an idea have violated their contract and their oath.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes, it should stop regulating speech and educate its staff and management on the rights of the people and the burden of the consumer to protect and educate themselves. Clearly, the FDA does not understand that the rights of the people also carry the responsibility for their choices. This is not the government's business.

EC -115