Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -337

Accepted - Volume 4

Comment Record
Commentor Mr. Jack Dunaway Date/Time 2002-09-05 15:09:05
Organization Mr. Jack Dunaway
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? The primary consideration for the FDA must be public health. If the public cannot trust communications regarding drugs, then those messages do not serve that consideration. The current crisis in public confidence appears to be turning cynical with a particularly apparent distrust of business and business practices. Since drugs have a special importance to public health, it seems obvious that an agency charged with the public trust has a functional duty to represent that interest as a fundamental and overriding concern. If the disillusionment of the public extends to human welfare then the entire enterprise will be nothing more than another example of corrupted self-interest trashing our collective goodwill. Drugs are held to a higher regulatory standard than dietary supplements consequently they demand more sensitivity with respect to their promoted use for the purported purpose. If the public needs to be protected from drug abuse then it is the FDA's obligation to be the front line of said defense. From a practical prespective, certain areas of public interest are more important than others. Certainly the lay public needs a higher level of protection than a licensed professional group of people that prescribe and dispense drugs. In general it is unnecessary and inappropriate for drugs to be promoted by the general press though advertising. Heretofor businesses had the good sense and taste to regulate themselves with respect to the apparent. Now however, it seems the trend is to degrade the communication media with commercial noise that serves only to confuse and stupify the consumer, the prey of predatory business. Learned intermediaries have a knowledge base and usually licensure that drug businesses must respect if communication is to be successful. The public lacks such discernment much like a child does. The public is the FDA's charge. Public health issues must always trump business interests. If not the FDA will seek it's funding from it's new masters and the corruption cycle will once again complete itself with predicable deteriorating public confidence.




EC -337