Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -312

Accepted - Volume 4

Comment Record
Commentor Ms. Jennifer Shafer Date/Time 2002-09-04 23:13:51
Organization Ms. Jennifer Shafer
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 basic issue here is whether corporations -- which are fictional persons created by law -- are entitled to the same First Amendment protections that real people enjoy, in regards to advertising. There are many reasons why they are not. * When corporations enjoy First Amendment protections it essentially nullifies the speech rights of individuals, since individuals cannot afford the massive advertising campaigns that corporations wage, and so cannot talk back. * Restrictions on the advertising of tobacco, alcohol, gambling and pharmaceuticals are essential for protecting public health. Of all the problems facing our country, insufficient advertising of cigarettes, liquor, etc. is not one of them. * Corporations use advertising to drive a wedge between parents and children, and seduce children to nag for junk food and other items that many parents oppose. * Children are especially vulnerable to advertising, because corporations use sophisticated psychological techniques to trick them, and because children lack the maturity to deal with these techniques. * Due largely to the assault of marketing to children, there have been marked increases in marketing-related diseases, such as childhood obesity and type 2 diabetes. * For the FDA, public health should be a higher priority than protecting corporations or their right to advertise. * Corporations are far too powerful already. The FDA should seek the right balance between individuals and corporations in the arena of public health, and not tip it further towards corporations and their lobbyists in our nation's capital. In addition, the FDA should work hard to maximize its authority to regulate commercial speech because: * Direct-to-consumer drug advertising exists primarily to promote the sale of drugs, not to educate. * Although the FDA does not currently have jurisdiction over tobacco, there are many proposals to give it such jurisdiction. If the FDA gains jurisdiction over tobacco, but has little power to regulate advertising, it would not be able to protect public health from the tobacco companies. Advertising of tobacco should be illegal in the United States. The marketing of infant formula has has had a dramatic effect on human beings most basic function, lactation and breatfeeding. In America woman are more likely to artificially feed their infants and young children than breastfeed. Many women feel incapable, especially when the hospital sends them home with a free bag of advertisements for infant formula. Every thing from bottle warmers, to formula. This is a problem that has caused a rise in infant death and breast cancer in women. When a woman does not complete the cycle of birth, lactation, and breastfeeding her body and her child suffer. All because the infant formula industry directly markets to this population. It's a SHAME! Corporations do not need anymore rights! When profits drive the speech , the speech must be controled by the citizens of this land.

EC -312