Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -413

Accepted - Volume 6

Comment Record
Commentor Mr. Howard C. Anderson Jr. Date/Time 2002-09-12 15:56:25
Organization North Dakota Board of Pharmacy
Category Health Professional

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? A) To begin this discussion, we need to restate that this regulation should be under the purview of State Boards of Pharmacy. Certainly, if FDA feels that there is a consumer health concern, they could and should work with the State Board of Pharmacy to resolve that issue. Having prefaced my remarks in this manner, I would say this. Whatever a pharmacist says in promoting a particular ability to compound or a specific product, what s/he says must be true. If s/he purports a product to be able to cure things that cannot be substantiated by research, that should be out of bounds. If, on the other hand, a pharmacist promotes his/her ability to compound or to make specific products for specific conditions then it is up to the physician to determine whether the patient has a condition which that product might suite. This should be a decision between the physician and the pharmacist and patient.
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? A) Positive effects of compounders and promotion of their compounding abilities. Promotion to physicians provides the physician with knowledge of the availability of a compounder and what that capabilities are of that compounder. Promotion of specific drugs or specific compounds allows the physician to make informed choices relative to treatment of patients, with the full knowledge of what alternatives are available in the marketplace. Knowledge that a compounder is available also allows the physician to adjust dosages for specific patients in a manner that is not available with manufactured products. Advantages to the consumer. There are many consumers who are not receiving satisfactory treatment for ailments, which have already been diagnosed. Knowledge of additional alternatives allows the consumer to discuss these with their practitioner to ascertain if these alternatives might be good choices for the patient. Additionally, there are patients who have not sought professional treatment for their ailment, either because their knowledge of the community around them seems to offer no solutions, or because they thought their ailment was something that could not be effected by medical treatment. A consultation with a pharmacist is often available to patients when physician consultation is more difficult to obtain. Once the patient is armed with knowledge, and the availability of treatment, they can then seek out a practitioner's help, either on their own or with the referral of the pharmacist, to ascertain if, in the practitioners opinion, that treatment might be effective for their particular ailment. Again, this information, provided to the patient and physician, must be true and backed up with some credible evidence of effectiveness. But, because of the nature of the compounded product, it may not be practical or feasible to do a new drug application process. Additionally, as drug companies continue to escalate their dollar amount needed to be recovered from a marketed drug, even the orphan drug program now requires very large amounts of money and expensive treatments in order to recover costs related to orphan drug marketing. Therefore, many effective treatments do not economically lend themselves to the type of research necessary for a new drug application. Practitioners and pharmacists can work together with patients to determine effective treatments for specific patients, which will never be available if we require new drug applications for all these therapies.
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? A) Here the FDA has always been reluctant to require face-to-face counseling with pharmacists. The FDA has always leaned towards sticking written material in with prescriptions. I believe that a requirement of a face-to-face consultation would go a long ways towards patient understanding while eliminating some of the problems, which we see with mail order and major compounders sending drugs all across the country.
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? When a pharmacist talks with patients or prescribers s/he does not fall under the description in this question. The pharmacist should not be a manufacturer or distributor S/he is is a compounding pharmacist. Again the key is to separate the compounders from the manufacturers first. Then leave the compounders to the Boards of pharmacy.

EC -413