Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -383

Accepted - Volume 6

Comment Record
Commentor Mr. John Ramsey Date/Time 2002-09-10 15:18:08
Organization Mr. John Ramsey
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? Absoulety there is the argument for regulating drug/pharmaceutical speech - as it is now, there is a crush of big drug advertising/promotions that make big about the effects of this new drug or that when, in reality, most of the the past decade's drug development has simply been retooling of existing compounds so as to either extend (some say almost illegally) copyright/patent claims or to continue to ramp up the steady gorging of the American public on their over-priced, often under-performing drugs. Even the rhetoric of the big drug companies trying to justify their ridiculously over-priced potions could stand some serious reining in. We hear all about how expensive it is to research for these drugs but reality shows that the drug industry has spent far, far more on promotion of their products than on research. For real. That's just the truth of the matter - wouldn't it stand to reason that the actual cost of drugs is driven up the most by what is the most costly in terms of overhead to the developing company? Using logic (and I hope that's safe to do), that would mean that the drug companies could easily reduce the overall cost of their products simply by cutting back on promotion and advertising. That responsibility lies with them - I don't think they'll lose their marketplace if they cut back from say, 90 Nexium/Clarinex/whatever ads on my television every day, to a more reasonable five or six. I mean, really, even if they had something important to say about the stuff, do we need to see it dozens of times a day? And most of it in the most expensive primetime ad slots to boot! Surely someone can grasp that by saving millions from NOT running needless advertising and promotion, the overhead costs of peddling these drugs will drop, which in turn may lead to actually increased market penetration as it becomes more accessible economically to the masses.... Continuing with this idea, since so many of the new drugs are actually retreads of existing compounds (5-day Prozac, Valtrex, Clarinex, etc.), is it even fair for the companies to claim research costs in association with these drugs? I venture that the cost of converting an existing drug into a slightly varied version is far less than the expense of creating an entirely original one. So, again using logic, it's fair to say that companies should not be allowed basically fib about how much a given drug's cost is attributable to its research cost, right? I firmly believe that it's misstatements of facts like this that need to be restricted just as much as pie-in-the-sky claims of effectiveness. Essentially for me, the fact that commercial speech is becoming more and more untouchable gives me pause as to what even to believe any more. While it may fall under free speech to tell a lie I don't find it at all appropriate when those lies are coming from commercial enterprises - how are the American public going to make sensible and informed decisions when we can't be sure of getting a straight answer on anything from anyone. Do *you* know what to believe in commercial speech nowdays? Do *you* think that it should be pretty much anything goes because that's their right? I certainly do not. Oh, it's not just drug companies, either....
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? Just give us the truth - if something only has 1/100 of bananna flavoring, it's not fair to label it a bananna.
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? Well, disclaimers themselves wouldn't really be necessary if we were operating on a real-truth system to begins with - what would there be to disclaim? If people aren't mislead to begin with, it's doubtful that much disclaiming is needed. However, when disclaiming, it certainly shouldn't be hidden, buried, laden with legal-speak, miniaturized, etc. If there's something to disclaim, speak it first, loud and often.
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? Well, I do believe that tons of stuff could be eliminated from our lexicon of consumption and we would need a lot less warnings...there's so much contradictory hype on every side of every issue that it's difficult to know what's best to believe. This dovetails with the comments given to question #1 pertaining to overall commerical speech - so much stuff is out there claiming this or that that warnings and such may be completely lost in the shuffle. I'm not sure what the best approach to this whole deal is but I do believe that warnings and exceptions and disclaimers need to be upfront, succint, clear and free of hype.
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? Well, again, if we were operating on the priniciples of truth, wouldn't this be a non-question? Claims made about a product - whether on the label or in promotional copy - should be consistent with one thing only and that's the truth. If a product truly does something special/better/unique then why is there the need to allow the ads to say one thing while restricting the labels to be more truthful?
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? Well, think about it - if the FDA says that drug X is tested safe for this use, then it should stand to reason that any other uses need to adhere to the same testing methods otherwise, why bother with making them test safe with the first thing to begin with? Or, would it be ok for companies to endeavor to earn approval for a single use and then assume carte blanche when telling people that it will cure everything else, too? Of course not. Aspirin isn't going to cure cancer and it's not fair for anyone to say that it is - off-label or wherever.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I'm just curious about what stance the FDA has concerning the free-speech rights of alternative treatments like cannabis? At what point should it be the FDA's concern to make sure that not only does false information NOT get spread in the first place but that maybe more valid and applicable information may lie over an alternative hill? This isn't just a direct-to-consumer, off-label issue but one of free-speech for health practitioners and alternative treatment researchers alike.




EC -383