Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -32

Accepted - Volume 1

Comment Record
Commentor Mr. Harold Hennes Date/Time 2002-05-28 22:51:47
Organization Mr. Harold Hennes
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? I think the FDA is violating the first amendment rights of venders of health products as long as they are not stating an outrright falsehood. I don;t see why the FDA is allowing the many drug companies to make false claims in their advertising especially in-as-much as most all drugs have seruous side effects and dangerous consequences.
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? Disclaimers are just so much verbiage. People pay little attentuion to them since they know they are required as a result thery become meaningless.
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? Not required
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? Anything required by the FDA is taken with a grain of salt.
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? Zero




EC -32