Confessions of a Hardened FTC Witness

Confessions of a Hardened FIC Wttness By ROBERT L. DAY

regulated. It simply means that it has, or has had, more dirty linen than other, less regulated industries. And it brought the situation on itself. I, for one, fully appreciate what the FTC has attempted to accomplish lately. What was once a sleepy rubber-stamping agency has become consumer conscious, and I would not like to see it restrained. Yet for all my admiration, I do have one complaint: I don't like the process it uses in promulgating (adopting) a trade regulation. I have some experience in ~his regard. I have been a participant in two FTC rulemaking procedures, both having to do with nonprescription drug advertisements.

Although oft lamented, it is an incontrovertible fact that our lives are regulated from womb to tomb. We cannot speed whenever we wish, nor can we tromp on a public flower bed. Some hidden but omnipresent local, state, or federal authority has posted signs everywhere advising us that we cannot, so we don't. And depending on one's perspective (flower grower or flower tromper), regulations are bound to be loved by some and resented by others. It is therefore fully understandable that large industries do not relish being regulated. Regulations, notably those from the Federal Trade Commission (FTC), restrain them from unrestricted profit making. As it turns out, there is an easy way of doing away with offensive FTC regulations. Evidently, all one need do is cry, "I'm being overregulated!" And if one is an influential industry, Congress will respond. That's what the funeral, optometric, and insurance industries did recently, and Congress promptly torpedoed the FTC, an agency that had the audacity to reveal that all of the aforementioned had engaged in anticompetitive activities. Even the President of the United States got into the act by promising to "dismantle unnecessary regulations"whatever that means. Yet it is a matter of record that federal regulations seldom anticipate abuses in the marketplace; they are triggered by them and constitute an effort (not always completely successful) to control them. I am therefore unimpressed when an industry claims that it is being over-

My involvement began in September 1976, when I was visited by two representatives of California Citizens Action Group, a consumer advocate organization. CALCAG had received a contract from FTC to represent consumers in a series of hearings to determine the advisability of adopting a rule that would restrain the manufacturers of nonprescription drugs from making claims in their advertisements that FDA does not permit on the product label.* CALCAG's contract called for it to provide attorneys and to obtain expert witnesses--! was approached because of my extensive involvement as an author and teacher in the field of nonprescription drugs and advertisements. As we talked, I can recall the somewhat naive impression I had of what being a witness at an FTC hearing would entail. I envisioned myself appearing before a panel of solemn FTC commissioners, clearly

Robert L. Day, PharmD, is associate dean for professional affairs and continuing education at the University of California School of Pharmacy, San Francisco, CA 94143.

*There is a clear separation in federal authority with regard to nonprescription drugs. FDA approves them, permits them on the market, and controls their labeling, but it has no regulatory authority over how they are advertised. That is within the jurisdiction of the FfC. On the other hand, FfC had no rule requiring that nonprescription drug advertisements conform to labeling claims. The hearings were to consider a proposed rule.

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Overture

and eloquently revealing the shoddy status of many current nonprescription drug advertisements. They would nod appreciatively, and when I concluded my testimony, they would thank me for bringing these serious matters to the attention of the Commission. Something, by cracky, would be done about it! My fantasy, however, was immediately punctured by the CALCAG representatives, Phil Neumark and Michael Schulman, both of whom were attorneys. I was informed that I would be addressing not the commissioners, but a hearing officerthe equivalent to a judge. In fact, the hearing would be very like a courtroom trial. Accordingly, I would be cross-examined, and while I could expect gentle treatment from the CALCAG and FTC attorneys, the "other side" (attorneys representing the advertising, broadcasting, and proprietary drug industries), would likely attempt to cut me to pieces. They would have ample opportunity to prepare themselves for this task because they would receive a copy of my written testimony at least one month in advance of the hearing. Furthermore, they were members of some of the most prestigious law firms in Washington, DC Although the prospect of this scenario was somewhat unsettling, I agreed to participate. We spent the months preceding the hearing devising strategies and lining up other witnesses. Our contract called for five witnesses. We were not particularly thrilled when we learned that industry had lined up 26 big guns, including Louis Lasagna, Arthur GroHman, and former FDA Commissioner Charles Edwards. We tried to anticipate what they would say. Eventually, it was decided that I would present CALCAG's overall position in support of the proposed rule. It was a broad platform that tripped into some areas in which I had little expertise, and I realized that I would be especially vulnera-

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ble during cross-examination. Our position called for a rule far more restrictive than the one being proposed. We wanted an advertising regulation: • Eliminating portrayals of anything other than realistic symptoms; • Prohibiting individual testimonials; • Banning the use of animated cartoons; • Requiring that advertisers report the "usual" time for relief to be obtained; • Requiring federal approval of every nonprescription drug advertisement in advance of its distribution. None of these notions was likely to be applauded by industry. The hearings began. One by one, our witnesses went to Washington . Then came my turn. I arrived a day early so I could be "prepped" by Phil and Mike. As a first step I was asked to listen to a tape recording of a witness being cross-examined by an industry attorney. He was eaten alive. The second step entailed a mock cross-examination, in which Phil and Mike played industry attorneys. It was devastating. I learned that I tended to ramble, was defensive, and spoke too rapidly. None of this was desirable because the hearing stenographer would not be able to keep up with me and because the attorneys from the "other side" would be able to ask more questions. As it was, they had requested three hours of cross-examination time. I was also provided with some hints, all of which proved useful : • Whenever my written testimony was quoted or paraphrased, I was to ask for the specific page and section . On reading it, I might learn that attorneys were capable of misquoting or taking a statement out of context. • If any document (scientific or otherwise) was cited during the course of a question, I was to ask to see a copy of it. On reading it, I might learn that it had been misquoted. (Besides, it would chew up some additional time.) If they could not provide a copy, I should refuse to speculate.

I was nervous when I took the stand the next day and read 25 pages of testimony word for word. Propped in front of me was Phil's small handprinted sign that said, "Talk s-1-o-w-l-y." I finished and looked up. The easy part was over. Cross- Examination The CALCAG and FTC attorneys asked only a few gentle questions, then sat down. The first lawyer from industry arose and smiled. It was, I thought, the smile of a spider to a fly. He began on a low key by asking me to admit to the many things that I am not. "Is it correct," he asked, "that you are not a physician?" "Yes." " ... a lawyer? ... an expert in mass advertising and mass media communications? .. . a linguist? ... an expert in marketing research and consumer surveys?" He paused after each category, awaiting the inevitable "yes" that added yet another item to my list of inadequacies. I knew what he was doing: he was trimming my tailfeathers. I had made what he perceived to be medical statements (but I wasn't a physician), I had talked about the interpretation of certain advertising claims (but I wasn't a linguist), and I had criticized advertising techniques (but I had no experience as a person engaged in mass media advertising). Having dispensed with the things that I am not, he got to what I am. Here it got sticky. He asked whether I had any "advanced training" in the analysis of nonprescription drug advertisements. The question surprised me. I had devoted a considerable portion of my professional and academic pursuits to this area over a period of many years. Did that not establish my credentials? Well, it didn't. He wanted to know whether I had studied under someone, perhaps in an advanced degree program. The problem, as both he and I knew, was that there were no such programs. I had trained myself and told him so . But he kept picking at it, and I began to ramble. Suddenly, it seemed as if

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the validity of everything I had said might hinge on whether I had undertaken advanced training. At a later time, I realized that I should not have been concerned about this, but he had made his mark. I became defensive, and the quality of my responses was affected accordingly . After a while, he left this line of / questioning and began to challenge my testimony. He asked whether I had any data to support an assertion I had made that the term "upset stomach" was imprecise. Data about what obviously was an ambiguous term? "No." Then came a series of questions having to do with unrelated comparisons. What posed a greater safety risk, he asked, toothpaste or pow-

'' Suddenly, it seemed as if the validity of everything I had said might hinge on whether I had undertaken advanced training.

_______,,, ertools? I told him that I had no data about that either. Would I then agree that there is a safety risk to automobiles? Only if the driver is unskilled, I answered (wondering where this was leading). He quoted my testimony: "Misleading advertisements for products and services in other areas of the marketplace may only result in the loss of money. With drugs, the stakes are somewhat higher." Then he went on: "In light of your statement ... is there a greater safety risk for consumers arising from the use of antiperspi-

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rants or automobiles?" I explained that this was a complex question that could not be answered without some definition from him of "safety" and a description of the conditions under which the products were used. This fruitless exchange continued for a while. Eventually, he thanked me and sat down, still smiling. Then the second industry attorney took a shot. By now I was irritated and had become quarrelsome. No more simple "yes" or "no" answers to questons; I took every opportunity to throw in something extra. Q: " . . . Is it your position that testimonials (in advertisements) will be a significant factor in the consumer's decision whether or not to purchase (a nonprescription drug)?" A: "Yes, or why would testimonials appear in the first place?" Q: (In regard to your testimony that exaggerated symptoms should be banned from advertisements) ... assuming a person has an upset stomach and sees an (antacid) advertisement in which an individual complains about stomach pains that are more extreme than his, wouldn't he conclude that his condition is not severe enough to warrant the application of the drug?" I answered no, that such a person might easily think, "If it helps that extreme problem, it will certainly help my less serious problem." And so it went, until-at long last-he thanked me and sat down. I silently thanked him. The ordeal was over; I had been on the stand nearly three hours.

Only One Step The hearings, however, are only one step in the rulemaking process. Adoption entails may phases and, unfortunately, moves at a snail's pace. The process in which I participated actually began in November 1975, when FTC formally announced its intention to require that nonprescription drug advertising claims conform to FDA-approved label claims. As is customary, "all interested persons" were invited to "submit views or arguments on any 40

issue of fact, law, or policy" that had some bearing upon the rule. Quite a few persons were interested; FTC's file cabinets literally overflowed with "views." Each response had to be read, evaluated, and tabulated by staff. In September 1976, having considered all views, FTC published a notice laying out the "disputed issues of fact" (roughly defined as quarrels and concerns about the proposed rule). January 12, 1977, was announced as the date on which the hearings would com-

'' The hearing ... touched on the interests of a multi bi II ion-dollar industry ...

_______,,, mence, and "all interested persons" were encouraged to testify. At the request of industry, however, the hearings were delayed until February 28, 1977, and were not completed until April 19. Then the "rebuttal" phase began. "All interested persons" now had the opportunity to provide written comment on the testimony of the witnesses. By the end of this phase, FTC had accumulated 4,230 pages of hearing transcripts and 9,600 pages of written submissions. October 1978 saw the release of the hearing officer's report (190 pages), which ana1yzed all comment and provided recommendations to the FTC commissioners. FTC staff also prepared a report (311 pages), which arrived on the scene in May 1979. Then came the "comment" phase; all interested persons were invited to take a stab at both reports. More

documents had to be read, evaluated, and tabulated. Sometime in the future, maybe this year, we will be advised of the Commission's decision. That will be more than four years from the time the rule was first proposed.

Problems, Problems Slow? Yes, but not without reason. Obviously, FTC must allow time for interested persons to respond to each phase. Moreover, FTC simultaneously considers a great number of new rules, and the staff assigned to any one rule is relatively small. And it takes time to go over every submitted document meticulously. Beyond this is political reality: FTC regulates big money interests, and it must move cautiously. Volunteer witnesses may be worn down by the rigor of the process; FTC staff members may leave for other positions, disrupting continuity; commissioners, members of the Congress, and even the President of the United States can change, or change their opinion about what a regulatory agency should be accomplishing. Thus the simple fact that the process takes time exposes it to a series of deleterious effects. There also are problems with the manner in which information is acquired and treated, some of which boil down to a question of money. FTC's funds for consumer intervention are limited (CALCAG received enough to send only five witnesses), so consumer input is de facto limited. The hearing at which I testified touched on the interests of a multibillion-dollar industry, which probably spent close to $1 million on this rule alone. Industry money brought in talent galore, attorneys and experts whose keen minds were able to define and subdefine the rule ad nauseam. Some industry-sponsored witnesses argued that nonprescription drugs were harmless and relatively free from adverse effects. Others attacked the credibility of the FDA OTC panels, thereby striking at the foundation of the rule. Still others

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