Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -142

Accepted - Volume 2

Comment Record
Commentor Mr. Keith Padgett Date/Time 2002-06-30 15:21:18
Organization Mr. Keith Padgett
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 FDA should get on with its' mandate to evaluate the safety and effectiveness of pharmaceuticals, foods, etc. rather than trying to over-regulate everything coming on the market. If the agency finds a product does not fulfill its' stated purpose then it should follow due civil court processes to stop the distribution of said porduct, but not dictate that all products must adhere to FDA pre-set guidelines before the market place has a chance to judge their benefits. If a product does not suit the market place it will die of natural causes. There are many FDA approved drugs that have a lot of marketing hype surrounding their advertisements that is no better (and sometimes worse) than the advertisements on non FDA sanctioned dietary supplements. If the FDA spent more time educating the public on what products do rather than trying to control all product information the truth would be better served. If a company lies about a product then the FDA should go to court to convince the judiciary of such rather than be the judge and jury as well as the prosecutor.
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? The FDA should be required to disprove claims by manufacturers, distributors, etc. rather than dictate companies prove beyond a shadow of doubt that a product is beneficial for everyone in all circumstances.
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? Not really. The fewer restrictions the better.

EC -142