Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -81

Accepted - Volume 1

Comment Record
Commentor Mr. Carl Scholten Date/Time 2002-05-30 22:38:28
Organization Mr. Carl Scholten
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? Drug manufacturers inherently design and produce a product that has predictable results, and products liability torts are prevented due to the lack of evidence and the complicated nature of patients prescription drug usage through current practices in the Medical and Psychiatric communities. In all fairness Drug Manufacturers should provide fully advertised images in advertisements advising of the types of side effects, ailments etc, and how they are experienced by people when taking the drugs. The images of a person smiling on Luvox, or prozac, or psychotropic psychiatric drugs, without also showing the images of the propensity for committing suicide or homicide while on the drug fails to properly inform the public about what Luvox etc. are now known to do. Currently Drug Manufacturers only provide advertisement images of positive results without allowing consumers to be properly informed with the images and impressions that are a result of the drug's usage as a side effect. As a result the fact that 3% of patients had a tendency to suicidal or homicidal acts while on a conditioned study during R & D of the drug before it was submitted to the FDA for approval, was omitted from the public knowledge, and the consequences in numbers of children, families etc killed is not even noted on the record by the FDA to this date. The advertisements to this day are devoid of this now publicly recorded knowledge. Survey results done on the Drug's advertisement research on their intended audiences will provide the evidence on this. There are trial court's public records and R & D Reseach evidence, and there are the withheld R & D documents revealed in Europe, and in the trial courts in a number of States of the US that supply this evidence.
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? Drug manufacturers should have a higher standard of obligation for announcing the known side effects and dangers and this should include all known side effects that were or are forever to be found out about, even when withheld from FDA during the submission process.
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? No
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? Make the patients sign an informed consent form on any drug presecription they take, that itemizes the known side effects, and limitation and possible gains from each drug, where the person initials each item as is customary with Insurance underwriting for automobile insurance in California By legislating strict tort law on pharmacuetical manufacturers, distributors and medical providers. Make it as painful as it is for an owner of a dog who bites people in California.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? Advertising is linked to Products Liability Tort Law. This is Drug Manufacturers risk, and the FDA has that risk too where they were nurturing the passage of drugs that were known to have unannouced ill side effects as is beinng discovered with Prozac, Luvox, and Psychotropic drugs that cause dimentia in patients who are overdosed by negligent practicianors like Psychiatrists, etc. No, labels are already being abused by the FDA in warning people about dietary supplements, when they haven't even reviewed the dietary supplement to begin with.
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? There is not ability of the FDA to regulate this.
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? No. And alternative approaches, yes. Get out of the buddy network with Pharmaceutical Manafucturers by making it illegal for an FDA employee to be employed by any Pharmacuetical Manufacturer, ever.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The regulation would be in the area of cleaning up your own house before restricting free speech.

EC -81