Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -342

Accepted - Volume 4

Comment Record
Commentor Ms. Mercedes Dzindzeleta Date/Time 2002-09-05 21:08:22
Organization Ms. Mercedes Dzindzeleta
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? Any promotional speech is inherently misleading unless it complies with 'rational' consumer understanding. If no comparison to long term safe use, like decades or centuries or FDA approved testing, then the promotional speech is for PROFIT to the drug company only.
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? The current position regarding direct-to-consumer (DTC) advertising is beyond careful consideration of cause and effect/affect for drugs, biologics, and/or devices. Consumer directed care, to physicians, based on mis-leading advertising is UNhealthy. FDA needs to consider the KISS principle firmly for any ads; for DTC's are extremely mis-leading.
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? Simple, Lay person language w/o legalize would be a great start to allow consumers to understand information about foods and supplements easily. To date claims and disclaims have been presented in the most ambiguious terms. BUT supplements and foods that have been used for decades and centuries successfully are to be considered 'tested' and safe. Laboratory testing in days and years is certainly not the same.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? Disclaimers need to be in Large size type and given greater priminence with claims. Small type is 'way to small'. When one needs a high powered magnifier to read disclaimers, they are seemingly irrelevant. And most people ignore fine print; hence why it is there. And medical institutions; esp hospitals and clinics have had to treat for mis-used drugs/etc.
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? Picture symbols have been very successful for all ages and levels of literacy. This followed by clear, concise and legibly large print to clarify safe usage.
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? The First Amendment is for legitimate, prove-able claims. Ads needs prominent dis-claimers and warnings; not fast spoken gibberage and small print that passes obscurely over scenery that distorts the print. Same with print ads - clear, prominent claims/dis-claims. Labels need clear information about 'safe' usage via laboratory testing, OR century long usage by cultures/peoples/herbalists.
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? Off-label use is 'suppositional' promotion. If used by manufacturers, distributors, and marketers to promote product use, this excedes the free speech claim and is not in the interest of consumers health.
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? Restricting the speech of ADs, is in the publics best interest. Allowing ambiguious speech from Corporations/companies for commercial speech is not protecting the public. If corporations/companies have 'human rights', than they, the corporation/company are also liable when wrong. To date, this has not been the case. It must revert to full responsibility by the corporation/company - if free to speak, then responsible of outcome/s.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? One important step would be pre-review by the FDA of ads; the current system relies on self-restraint by drug manufacturers and a very inadequate and underfunded system of FDA warning letters sent after offending advertisements are aired or published. DTC advertisers should be required to run corrective ads after receiving FDA warning letters. Consumers need to be empowered with useful information. This needs to be provided by the FDA on the Internet, in inserts included with pharmaceuticals, and elsewhere. The information needs to be written in easy-to-understand language, and include information on success rates, and comparative efficacy and pricing data. This is how consumers' right to know needs to be satisfied; NOTthrough promotional advertisements that are inevitably slanted.

EC -342