Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -313

Accepted - Volume 4

Comment Record
Commentor Mr. Charles Firth Date/Time 2002-09-04 23:39:45
Organization CBFirth Copywriting for Industry
Category Company

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 companies influence physicians who influence patients… The biggest distinction between the sale of, and speech related to, drugs (relative to dietary supplements and other non-prescription substances) is that drugs are available only by prescription which generally requires consultation with a medical authority. This authority, usually an MD, is perceived by the drug recipient to have expertise regarding the drug and its effectiveness. This perception enables the MD to wield a great amount of influence on the drug recipient's decision making process. In turn, it is a well known fact that pharmaceutical companies wield a great amount of influence with medical practitioners. My sister, who is a board-certified physician has told us of many free vacation offers plus other freebies and sales presentations designed to get her attention and convince her that a particular drug is something she should prescribe to her patients. It is a powerful lobbying effort that generally focuses on a drug's perception and the relationship between the physician and the drug company's sales representative rather than any specific, or well understood, scientific basis for prescribing the drug. Drug companies have monopolies… Furthermore, the pharmaceutical companies often own lucrative patents on specific formulations which give them a defacto monopoly on specific cures or remedies. This enables them to generate tremendous amounts of profit from their formulations -- profits that can be used to do a tremendous amount of advertising and lobbying and substantially influence potential buyers, as well as physicians. With this amount of influence should come a greater amount of responsibility to tell the entire truth -- as it is known -- to their customers. Drugs can be risky… In addition, the sorts of substances generally manufactured by drug companies -- substances of the prescribed sort -- are generally much riskier than the typical dietary supplement. They are often very specific to a particular biochemical function or process and capable of resulting in severe side effects -- of which the user must be warned in advance. Therefore, it is imperative that communications by drug companies with the general public be balanced and provide a complete picture of the drug in question. Potential users must be made fully aware of possible side-effects and should also be made aware of what is not known. Drug companies perpetuate a myth… In the end, it would be better if we, as a society, looked further than our medicine cabinets when in need of a cure. Dietary changes, exercise, relaxation techniques are all known to be powerful disease preventatives. What is the hope that we, as a society, will become more proactive and responsible about our own individual health issues when large, international corporations are enabled to perpetuate the myth that disease just happens and that the solution is not to be found in ourselves but in a pill?
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? We are a society that over-medicates... Does pharmaceutical advertising add to the problem of over-medication? Of course it does. But we were over-medicating before recent changes in pharmaceutical consumer advertising. Over-medication has been due mainly to the heavy lobbying of physicians and medical schools by drug companies. This has helped perpetuate the myth that a pill -- or reactive approach to disease -- is an acceptable alternative to taking proactive, personal responsibility for one's own health. Yet with the added pressure of emotion-based consumer advertising of pharmaceuticals, today the physician finds herself being squeezed from both sides with drug companies lobbying the physician directly and also lobbying the consumer directly. This causes consumers to request drugs that might not be suitable for them but which they have become convinced will cure their condition (which they may or may not have). Some physicians, in a misguided attempt to give the patient what he or she wants, yield to this pressure and prescribe drugs unnecessarily. This is especially apparent in the case of antibiotics which are losing their effectiveness as a result -- a serious problem in the treatment of bacterial infection.
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? Distinctions can be easily made, but are they enough? I believe that a clear distinction can first be made between foods or food supplements -- substances that may contain active ingredients but in a complex nutritional context -- and products that are isolated extractions of active ingredients or synthesized reproductions of active ingredients without such a nutritional context. Secondly, this category of isolated extractions can be broken down into those substances which are known to naturally occur in the human body and those that are not known to occur in the body. Beyond these two major distinctions, one could argue that any substance that 1) does not occur in a natural nutritional context (for example, an herbal remedy) but is a pure extraction of an active ingredient and 2) is not a substance known to occur naturally in the human body should only be allowed on the shelf with a satisfactory series of clinical human trials. However, is this realistic? How many effective remedies would be denied the public? Many. I recently self-treated a mild depression with two products available at the local grocery store -- St. John's Wort and 5-HTP. They worked great, were less expensive than Zoloft or Prozac, had no noticeable side effects and did not require the intervention of a medical professional. The benefit of such an approach to society is obvious -- a healthier individual at a lower cost. So at some point, we simply have to apply common sense. Sure, many, if not most, so-called supplements on the shelves today do nothing beyond provide a placebo effect. But so what? The placebo effect may turn out to be more of a cure than many prescription drugs that do more damage than good. Besides, many of these same supplement products are being sold by subsidiaries of pharmaceutical companies anyway. Are they complaining about it? Unless people start getting sick, or are getting seriously ripped off, I say let them decide for themselves. When it comes to human trials, let's focus on those products that are most likely to do harm or that are targeted at highly specific biochemical processes. For years we did not know how aspirin was able to reduce pain. But it worked and it did not seem to do much harm. So we let it be and it was a good thing. Let's keep using this kind of common sense approach. I am very happy with the words this claim has not been validated by the FDA. In other words, experiment at your own risk.
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? Let's use technology... Disclaimers should be required and should be readable. However, in addition it would be useful to assemble a substance repository on the Internet where all known, reliable research pertaining to a given drug or supplement could be easily found and reviewed. The url to that repository would be given some prominence on product labels. Let's give the consumer reliable information and some responsibility as well.
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? I would imagine that the CDC should analyze the ratio between the number of prescription drug or supplement related overdoses/deaths with the particular product and the labels provided.
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? Advertisements cannot, by nature, in 30 or 60 seconds, communicate all of the necessary precautions and relevant issues pertaining to a biologically active chemical. That's a given. However, the biggest problem with drug advertisements is that they generally perpetuate the myth that a reactive drug regimen is better than a proactive nutrition- and exercise-based approach to health. We should curb and keep a lid on drug advertising because it perpetuates a myth in general, not because it may or may not be completely accurate relative to a specific drug. In a sense, all drug ads, like all fast food ads, are false advertising. The result that is generally portrayed -- a happy life, brimming with health and activity -- is generally not the result of a reactive approach to health.
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? Such claims must be substantiated in some way. In reality such findings are usually the result of a study which may include certain surprises. The problem is when the manufacturer jumps to a conclusion about certain findings and makes a sweeping claim before the facts are all in. Let's use common sense here and let physicians make some of the calls in this area. We should absoultely not let such claims be advertised in the mass media until substantiated in some way.
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? I think the system we have has worked pretty well relative to the regulation of medicinally oriented speech. However, I do bristle at the drug -- and supplement -- ads which suggest taking a pill is the answer to a health problem which was likely caused by poor nutrition, too much stress, a sedentary life style or smoking and alcohol consumption. For example, take acid reflux. We are being bombarded with ads for acid reflux remedies. In reality, acid reflux is most likely caused by nutritional and stress-related factors. Changes in diet and lifestyle could cure most cases of acid reflux instead of just masking the symptoms -- which is what the new drugs do. Is this the way we want to go? To continue perpetuating the myth that people should destroy their bodies and then take a pill to make it all better? I really think we need to consider the effects of this kind of over-commercialization. What message are we sending to our kids? Not to worry son, there's a pill that will fix that up so just keep right on eating those Big Macs and smoking those Camels? I don't think so.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think the FDA should consider the overall claims of drug and supplement companies and the general effects of over-commercialization. If I was going to add a disclaimer to most drug and supplement label it would be: Caution: No drug or supplement is a substitute for a healthy life style that incorporpates proper nutrition, exercise and stress management techniques. Learn to be proactive about your health!

EC -313