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Legal Blotter
LEGAL BLOTTER by Robert F. Steeves, director of APhA's legal division
regulation of non-prescription drug advertising Advertising in its various forms . exerts a tremendous influence on pharmaceutical practice. From the personal communication of the medical representative to the mass cammunication af television, the pharmacist is subject to the results af advertising persuasian on the physician and the public. The community practice of pharmacy, in particular, can be greatly influenced by massive advertising campaigns addressed to' the public. Not .only daes this advertising pramote the purchase of products the cammunity pharmacist distributes, but it also results in the pharmacist's being asked to verify advertising claims or to distinguish between campeting products. Most pharmacists are aware that prescription drug advertising is monitored by the Food and Drug Administration as authorized by the Food, Drug and Cosmetic Act. Tao, most pharmacists realize that prescription drug advertising is subject to' the requirement of "full disclosure" which pravides the physician and the pharmacist with additianal infarmatian on prescription drugs. The demand for APhA' s Handbook of N on-Prescription Drugs is evidence that pharmacists also desire more informatian about non-prescriptian drug products they often are called on to recammend to patients. The information provided by the labeling of nonprescription drugs is seldam adequate to guide a reasoned chaice of any particular product. Moreaver, the advertising of non-prescriptian drugs frequently seems to' encourage an unreasonable use of many nan-prescriptian drugs. As a result, many pharmacists must often wander who monitors non-prescriptian drug advertising and to' what extent such advertising can be regulated. The chief regulatory agency concerned with non-prescription drug advertising is the Federal Trade Commission. A 1938 amendment to the Federal Trade Commission Act gave the 90
commission specific authority over false advertising of "food, drugs, devices or cosmetics," but not over labeling or advertising directed only to the medical prafession. As defined by the act, "false advertising" includes advertising which is false or "misleading in a material respect." Although this definitian is essentially negative, it is broad enough to apply to a failure to reveal material facts in some instances. The commission is empowered to act when it has reason to believe that someone is advertising in a manner forbidden by the act-if the commission believes a proceeding would be in the public interest. Originally, the act did not allow the commission to take actian unless the forbidden practice caused injury to a competitor. This was changed by the 1938 amendment to the act authorizing the cammission to proceed against false advertising which may cause public injury. While an important part af the functian af the Federal Trade Cammission involves praceedings against individual vialators, more significant is the general industry guidance which the commISSIon provides. Because it would be impossible to prasecute all of the great number of complaints the cammission receives each year, methads af voluntary compliance assume great importance. These methods include advisory opinions, guidelines written in laymen's language and adoption of rules and regulatians. Recently, the commission has begun to' place greater emphasis an Trade Regulations Rules as a means of achieving voluntary compliance. By establishing industry-wide 'c ampetitive standards, these rules avoid the inequity which may result from proceeding against a few . industry members when th·e . practice is common throughout an industry. In July of this year, the commission propased a Trade Regulation Rule to provide standards for the advertising of a particular group of non-prescrip-
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
tion drugs-the systemic analgesics. As proposed, the rule would prahibit advertising claims for the specified products that exceed claims permitted in the labeling of the products. Further, the prapased rule would restrict advertising claims that a product is "faster, stronger, or longer lasting" than a competitive product and wauld also restrict advertising claims based on a specified ingredient or combination of ingredients. In supporting the rule as prop as ed, APhA stated it could "see no justification for advertising claims exceeding those allowed by labeling requirements." The Assaciation indicated it does not support advertising which attempts to create a demand for a drug where there is no medical justification for its use. And it was also noted that the "Association believes non-prescription drug advertisjng presenting health related claims and directed to the public should accurately inform so that consumers may become more knowledgeable about drugs available for self-medication." ~lthough more informative advertising of non-prescription drugs is desirable, it was through legislation that "full disclosure" became the standard for the advertising of prescription drugs. Thus, legislation may also be necessary to accomplish more informative advertising of non-prescription drugs. The Federal Trade Commission may be able to discourage abuses in non-prescription drug advertising using methods of voluntary compliance-as it is attempting to do by proposing the rule concerning advertising of non-prescription systemic analgesics. Under present law, however, the commission can require affirmative disclosure only in limited circumstances. Consequently, as long as its regulatory power remains largely negative, it is unlikely that the commission will be able to achieve the positive result of more informative advertising of nonprescription drugs.
regulation of non-prescription drug advertising Advertising in its various forms . exerts a tremendous influence on pharmaceutical practice. From the personal communication of the medical representative to the mass cammunication af television, the pharmacist is subject to the results af advertising persuasian on the physician and the public. The community practice of pharmacy, in particular, can be greatly influenced by massive advertising campaigns addressed to' the public. Not .only daes this advertising pramote the purchase of products the cammunity pharmacist distributes, but it also results in the pharmacist's being asked to verify advertising claims or to distinguish between campeting products. Most pharmacists are aware that prescription drug advertising is monitored by the Food and Drug Administration as authorized by the Food, Drug and Cosmetic Act. Tao, most pharmacists realize that prescription drug advertising is subject to' the requirement of "full disclosure" which pravides the physician and the pharmacist with additianal infarmatian on prescription drugs. The demand for APhA' s Handbook of N on-Prescription Drugs is evidence that pharmacists also desire more informatian about non-prescriptian drug products they often are called on to recammend to patients. The information provided by the labeling of nonprescription drugs is seldam adequate to guide a reasoned chaice of any particular product. Moreaver, the advertising of non-prescriptian drugs frequently seems to' encourage an unreasonable use of many nan-prescriptian drugs. As a result, many pharmacists must often wander who monitors non-prescriptian drug advertising and to' what extent such advertising can be regulated. The chief regulatory agency concerned with non-prescription drug advertising is the Federal Trade Commission. A 1938 amendment to the Federal Trade Commission Act gave the 90
commission specific authority over false advertising of "food, drugs, devices or cosmetics," but not over labeling or advertising directed only to the medical prafession. As defined by the act, "false advertising" includes advertising which is false or "misleading in a material respect." Although this definitian is essentially negative, it is broad enough to apply to a failure to reveal material facts in some instances. The commission is empowered to act when it has reason to believe that someone is advertising in a manner forbidden by the act-if the commission believes a proceeding would be in the public interest. Originally, the act did not allow the commission to take actian unless the forbidden practice caused injury to a competitor. This was changed by the 1938 amendment to the act authorizing the cammission to proceed against false advertising which may cause public injury. While an important part af the functian af the Federal Trade Cammission involves praceedings against individual vialators, more significant is the general industry guidance which the commISSIon provides. Because it would be impossible to prasecute all of the great number of complaints the cammission receives each year, methads af voluntary compliance assume great importance. These methods include advisory opinions, guidelines written in laymen's language and adoption of rules and regulatians. Recently, the commission has begun to' place greater emphasis an Trade Regulations Rules as a means of achieving voluntary compliance. By establishing industry-wide 'c ampetitive standards, these rules avoid the inequity which may result from proceeding against a few . industry members when th·e . practice is common throughout an industry. In July of this year, the commission propased a Trade Regulation Rule to provide standards for the advertising of a particular group of non-prescrip-
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
tion drugs-the systemic analgesics. As proposed, the rule would prahibit advertising claims for the specified products that exceed claims permitted in the labeling of the products. Further, the prapased rule would restrict advertising claims that a product is "faster, stronger, or longer lasting" than a competitive product and wauld also restrict advertising claims based on a specified ingredient or combination of ingredients. In supporting the rule as prop as ed, APhA stated it could "see no justification for advertising claims exceeding those allowed by labeling requirements." The Assaciation indicated it does not support advertising which attempts to create a demand for a drug where there is no medical justification for its use. And it was also noted that the "Association believes non-prescription drug advertisjng presenting health related claims and directed to the public should accurately inform so that consumers may become more knowledgeable about drugs available for self-medication." ~lthough more informative advertising of non-prescription drugs is desirable, it was through legislation that "full disclosure" became the standard for the advertising of prescription drugs. Thus, legislation may also be necessary to accomplish more informative advertising of non-prescription drugs. The Federal Trade Commission may be able to discourage abuses in non-prescription drug advertising using methods of voluntary compliance-as it is attempting to do by proposing the rule concerning advertising of non-prescription systemic analgesics. Under present law, however, the commission can require affirmative disclosure only in limited circumstances. Consequently, as long as its regulatory power remains largely negative, it is unlikely that the commission will be able to achieve the positive result of more informative advertising of nonprescription drugs.