- Email: [email protected]
FDA Conducts Consumer Exchange On Prescription Drug Advertising
tional advertising in the United States. "This kind of advertising, after all, has a far different audience in terms of knowledge, perception, and interest than does advertising to the medical profession . We believe it is possible that the full statement of side effects and contraindications required for advertising to the medical profession often has a negative effect on an audience not trained in medicine," Adams said. He offered several suggestions for providing a fair balance of information, including-for print media-simplifying the language of the advertisement itself and of the required statement of side effects. For radio and television, he suggested developing a statement that would refer the consumer to his or her own physician or other prescribing health care professional. He offered the following such statement for consideration: This pharmaceutical product can only be prescribed by a registered physician. Almost all medicines have side effects and limits of use, and only a physician knowledgeable of your particular case can determine the correctness of your use of this product. Follow his advice and his counsel, and be careful to take any medicine he prescribes only as his instructions indicate. Adams suggested that on radio, these words could be spoken; on television, they could be superimposed on the screen or "crawled" across the screen during the commercial.
Consumer Acceptance Whether these advertisements could meet regulations is one question; whether people want the advertisements at all is another. APhA, represented at the meeting by Professional Affairs Director Richard Penna, took a neutral stand on the question, because APhA had rescinded its policies relating to prescription drug advertising, due to an antitrust suit brought against APhA by the U.S. Department of Justice. However, Penna did cite a recent American Pharmacy Vol. NS23, No. 6, June 1983/261
AARP's Wegner: Consumers look to FDA for drug information
poll of pharmacists in which 69% of respondents opposed direct-to-consumer advertising of prescription drug products. He also noted that a successful form of advertising is now taking place in the promotion and press coverage surrounding FDA approval of a new drug product. Leonard Fenninger, MD, of the American Medical Association, stated that his organization had no policy on consumer advertising. He raised some interesting questions for the FDA's consideration: Will advertising come between the patient and physician? Will the physician have to spend more time discussing advertising the patient has seen than on the patient's medical problems? Will advertistments increase patients' understanding of drugs and disease and prompt them to take proper preventive and treatment measures? Will advertising increase or decrease drug costs? Consumer groups at the meeting did not hestitate to make their position clear. Both consumer representatives who were on the program (from the American Association of Retired Persons and the Consumer Federation of America) as well as a number of consumer representatives who spoke from the floor flatly opposed the concept of direct-toconsumer advertising. Basically, their positions were that such advertising will do more harm
than good; that product promotion-not consumer education- is the goal of advertising; and that such ad vertising would increase the price of prescription drugs. Fred Wegner, speaking for AARP, cited a Harris poll indicating that consumers don't look to industry for their drug information. Asked what source provides the most accurate information about drugs, half the respondents indicated the FDA, 29% indicated consumer organizations, and 9% indicated drug companies, Wegner said. Responding to a statement from the floor by Ciba-Geigy's David Taylor, that while some drugs are not appropriate for advertising to consumers, some would be appropriate if advertising helps to fulfill the patients' needs, Consumer Federation of America's Anne Averyt said that filling patients' educational needs can be met by public service announcements. She indicated that while she opposed advertising to consumers, drug industry-sponsored public service announcements would be appropriate. -Patricia A. Mullan
EmulsiMI!9 Wax,N.F.?* COIllactCrocia. 183 Madison Ave. New York, NY 10016 Tel. (212) 685-9382
*xv, 1975.
5
.......
FDA Conducts Consumer Exchange On Prescription Drug Advertising While direct-to-consumer advertising of prescription drugs has been tried by a few drug companies and pharmacies, enthusiasm for the idea is guarded, if the tone of a Food and Drug Administration consumer exchange meeting held this March is any indication. Health professionals, represented at the meeting by APhA and the American Medical Association, took a neutral position on such advertising; FDA also claimed neutrality; consumers were adamantly opposed to it; and even those with the most to gain from it economicallydrug companies and advertising agencies-seem to have adopted a wait-and-see attitude. FDA Commissioner Arthur Hull Hayes, who chaired the meeting, remarked on the hesitancy among participants to "come forth with strong points of view," and suggested that this indicates an awareness that problems do exist with such advertising. Direct-to-consumer advertising has become an issue in the past two years since several companies broke with tradition and advertised prescrip-
AAAA's Adams: Simplified language
tion drug products in general circulation magazines and newspapers. For example, Merck, Sharp & Dohme ran an advertisement in Readers Digest to announce the availability of Pneumovax; the Peoples Drug Store chain placed an advertisement in The Washington Post for Burroughs Wellcome's Zovirax; and Boots Pharmaceu ticals ran a rebate coupon in consumer publications for Rufen brand of ibuprofen. The flurry of direct-to-consumer advertising has raised the question-although these advertisements are not illegal-of whether they are feasible or advisable. To answer this, FDA has begun a series of meetings, inviting consumers, health practitioners, drug companies, and advertising agencies to express their opinions.
must also include relevant warnings and risks associated with the product's use. Whether it is feasible for advertisers to meet this requirement is a big question. While it may not be difficult to provide fair balance in print advertisements, Hayes pointed out that it may not be possible to meet existing requirements for fair balance within the 30-60 second timeframe of an average television or radio commercial. One option is lengthening these commercials. Another is redefining the concept of fair balance. Hayes has asked industry for a voluntary moratorium on direct-toconsumer advertising until the matter is clarified. "The current regulations for advertising these products are now identical both for advertising to the medical profession and to the consumer. We believe the time has come to question whether or not this is necessary or desirable," said Charles Adams, executive vice president of the American Association of Advertising Agencies, the members of which place about 75% of all na-
A JFair Balance'
FDA's Hayes: 'Voluntary moratorium' on consumer advertising
4
Hayes reminded participants at the first meeting on the subject that while there is no legal prohibition on direct-to-consumer advertising of prescription drugs, current regulations for prescription drug advertising require a "fair balance" of information; that is, if an advertiser cites the advantages of using its product, it
APhA's Penna: Polls show pharmacists opposed
American Pharmacy Vol. NS23. No.6. June
1983126~
Consumer Acceptance Whether these advertisements could meet regulations is one question; whether people want the advertisements at all is another. APhA, represented at the meeting by Professional Affairs Director Richard Penna, took a neutral stand on the question, because APhA had rescinded its policies relating to prescription drug advertising, due to an antitrust suit brought against APhA by the U.S. Department of Justice. However, Penna did cite a recent American Pharmacy Vol. NS23, No. 6, June 1983/261
AARP's Wegner: Consumers look to FDA for drug information
poll of pharmacists in which 69% of respondents opposed direct-to-consumer advertising of prescription drug products. He also noted that a successful form of advertising is now taking place in the promotion and press coverage surrounding FDA approval of a new drug product. Leonard Fenninger, MD, of the American Medical Association, stated that his organization had no policy on consumer advertising. He raised some interesting questions for the FDA's consideration: Will advertising come between the patient and physician? Will the physician have to spend more time discussing advertising the patient has seen than on the patient's medical problems? Will advertistments increase patients' understanding of drugs and disease and prompt them to take proper preventive and treatment measures? Will advertising increase or decrease drug costs? Consumer groups at the meeting did not hestitate to make their position clear. Both consumer representatives who were on the program (from the American Association of Retired Persons and the Consumer Federation of America) as well as a number of consumer representatives who spoke from the floor flatly opposed the concept of direct-toconsumer advertising. Basically, their positions were that such advertising will do more harm
than good; that product promotion-not consumer education- is the goal of advertising; and that such ad vertising would increase the price of prescription drugs. Fred Wegner, speaking for AARP, cited a Harris poll indicating that consumers don't look to industry for their drug information. Asked what source provides the most accurate information about drugs, half the respondents indicated the FDA, 29% indicated consumer organizations, and 9% indicated drug companies, Wegner said. Responding to a statement from the floor by Ciba-Geigy's David Taylor, that while some drugs are not appropriate for advertising to consumers, some would be appropriate if advertising helps to fulfill the patients' needs, Consumer Federation of America's Anne Averyt said that filling patients' educational needs can be met by public service announcements. She indicated that while she opposed advertising to consumers, drug industry-sponsored public service announcements would be appropriate. -Patricia A. Mullan
EmulsiMI!9 Wax,N.F.?* COIllactCrocia. 183 Madison Ave. New York, NY 10016 Tel. (212) 685-9382
*xv, 1975.
5
.......
FDA Conducts Consumer Exchange On Prescription Drug Advertising While direct-to-consumer advertising of prescription drugs has been tried by a few drug companies and pharmacies, enthusiasm for the idea is guarded, if the tone of a Food and Drug Administration consumer exchange meeting held this March is any indication. Health professionals, represented at the meeting by APhA and the American Medical Association, took a neutral position on such advertising; FDA also claimed neutrality; consumers were adamantly opposed to it; and even those with the most to gain from it economicallydrug companies and advertising agencies-seem to have adopted a wait-and-see attitude. FDA Commissioner Arthur Hull Hayes, who chaired the meeting, remarked on the hesitancy among participants to "come forth with strong points of view," and suggested that this indicates an awareness that problems do exist with such advertising. Direct-to-consumer advertising has become an issue in the past two years since several companies broke with tradition and advertised prescrip-
AAAA's Adams: Simplified language
tion drug products in general circulation magazines and newspapers. For example, Merck, Sharp & Dohme ran an advertisement in Readers Digest to announce the availability of Pneumovax; the Peoples Drug Store chain placed an advertisement in The Washington Post for Burroughs Wellcome's Zovirax; and Boots Pharmaceu ticals ran a rebate coupon in consumer publications for Rufen brand of ibuprofen. The flurry of direct-to-consumer advertising has raised the question-although these advertisements are not illegal-of whether they are feasible or advisable. To answer this, FDA has begun a series of meetings, inviting consumers, health practitioners, drug companies, and advertising agencies to express their opinions.
must also include relevant warnings and risks associated with the product's use. Whether it is feasible for advertisers to meet this requirement is a big question. While it may not be difficult to provide fair balance in print advertisements, Hayes pointed out that it may not be possible to meet existing requirements for fair balance within the 30-60 second timeframe of an average television or radio commercial. One option is lengthening these commercials. Another is redefining the concept of fair balance. Hayes has asked industry for a voluntary moratorium on direct-toconsumer advertising until the matter is clarified. "The current regulations for advertising these products are now identical both for advertising to the medical profession and to the consumer. We believe the time has come to question whether or not this is necessary or desirable," said Charles Adams, executive vice president of the American Association of Advertising Agencies, the members of which place about 75% of all na-
A JFair Balance'
FDA's Hayes: 'Voluntary moratorium' on consumer advertising
4
Hayes reminded participants at the first meeting on the subject that while there is no legal prohibition on direct-to-consumer advertising of prescription drugs, current regulations for prescription drug advertising require a "fair balance" of information; that is, if an advertiser cites the advantages of using its product, it
APhA's Penna: Polls show pharmacists opposed
American Pharmacy Vol. NS23. No.6. June
1983126~