Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -247

Accepted - Volume 4

Comment Record
Commentor Mrs. Barbara J. Rickett Date/Time 2002-07-28 21:44:06
Organization None
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? I believe that the FDA has handcuffed the dietary suplemental industry. They SHOULD be able to make claims if they can back them up. There should be a simple standard of checks on dietary products makeing sure their ingredients are as they claim. Very few people die from supplements, while the 4th leading cause of DEATH is the USE of properly prescribed drugs. THIS DEATH RATE IF OVER 100,000 PER YEAR. I WOULD LIKE TO KNOW HOW MANY FDA APPROVED DRUGS HAVE HAD TO TO PULLED FROM THE MARKET IN THE LAST 5 YEARS DO TO HEALTH PROBLEMS OR DEATHS.
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? All FDA drugs are toxic and most people have no idea. The advertisement (MILLIONS spent)has to be paying off big for the pharmaceutical companies or they wouldn't continue their ads. Yes, the promotion of prescriptions drugs DOES LEAD TO OVER PRESCRIPTION. The ads are so inticing that people will go to their Doctor and ask if they need this or that drug, not even knowing what medical problem the ad is covering. Most Doctors seem very willing to prescribe whatever is being advertised. VERY FEW people understand the RISKS! ALL FDA approved drugs MUST KILL a certain percentage of animals before they are approved. MOST drugs DO NOT CURE disease, but simply mask the problem. Each drug has to have double-blind studies. But their are NO studies conducted as to how they will react to other prescription drugs that doctors will prescribe.BUSY doctors will take the word of FDA and pharmaceutical reps instead of studying for themselves other options.

EC -247