From: Dennis Hans [hans_d@popmail.firn.edu] Sent: Wednesday, September 04, 2002 6:51 PM To: fdadockets@oc.fda.gov Subject: public comment on commercial advertising and FDA oversight Dear FDA: My comment takes the form of a 1,008-word essay, titled “This is your brain. This is your brain trying to comprehend the different standards for drug advertisements." I examine the wildly differing standards for televised commercial messages for drugs, depending on the category of drug. Some messages must provide balanced information that lays out risks as well as benefits; others must be 100 percent negative; still others can be mostly positive. The degree of danger posed sometimes is a factor in the standard; other times, it is irrelevant. Sometimes the government regulates aggressively, other times it leaves a drug industry largely to its own devices. I look at prescription drugs, nicotine, illicit street drugs and alcohol. Best regards, Dennis Hans, 11401 - 9th St. N. #2006 St. Petersburg, FL 33716 (727) 577-2127 Bio: Dennis Hans is a freelance writer whose essays have appeared in the New York Times, Washington Post, National Post (Canada) and elsewhere. He has taught courses in mass communications and American foreign policy at the University of South Florida. Among his areas of interest are the mixed messages about mind-altering drugs delivered by the government, pro sports and the media. He can be reached at HANS_D@popmail.firn.edu. Please italicize the words within arrows < > This is your brain. This is your brain trying to comprehend the different standards for drug advertisements. by Dennis Hans So you fellas want to advertise your drug on TV? Terrific! In case you didn’t already know, there are different advertising standards for different drugs. Let me tell you about them. If your commercial is for a prescription pharmaceutical drug, it must provide a fair assessment of the benefits and risks and describe the side effects that can occur when the consumer uses the drug as prescribed. The Food and Drug Administration regulates these ads -- after they’ve gone out over the airwaves for a spell. If an ad is misleading, the FDA has the authority to yank it off the air. But just between you and me, as watchdogs go the FDA is on the sleepy side. Unless you tell a whopper it won’t even bark, let alone bite. If you want to advertise the drug nicotine, the message must be 100 percent negative. Some of the best sponsors on teen-oriented shows are the anti-tobacco groups. Governments give them big bucks to produce and air commercials on the dangers of smoking and the wickedness of tobacco executives. That’s only fair, considering for many years that networks ran nothing but seductive ads that helped persuade millions of youngsters to light up. That wouldn’t have been such a bad thing except nicotine has one of the highest addiction rates. Now that wouldn’t be such a bad thing given that nicotine fiends, unlike crackheads and alcoholics, aren’t dangerous to themselves or others when under the influence. Of course, the long haul is another story: As a consequence of their habit, 33 percent of smokers die before their time, which is reason enough to focus solely on the downside. The networks also run ads by the tobacco companies themselves urging youngsters not to smoke. Mind you, they youngsters to smoke. Companies know they gotta hook ’em early, because hardly anyone waits till adulthood to give cigs a try. No, these ads are an insurance policy against future lawsuits: They can say, “Didn’t we warn you when you were ten not to take up smoking?” One tobacco giant, Phillip Morris, also spends hundreds of millions on ads to tell viewers about the million or two it spends to help women battered by disturbed, drunken husbands and boyfriends. Now let’s say you want to advertise a mind-altering, recreational drug. Boob-tube barons accept ads for illicit street drugs -- negative ads, that is, produced for the White House Office of National Drug Control Policy (ONDCP) by the Partnership for a Drug-Free America. The Partnership is a band of dedicated advertising and communication professionals who donate their time and talents to warn youngsters about the dangers of those drugs that don’t enrich the advertising industry. The government has zero tolerance for balanced presentations of the risks, benefits and side effects of marijuana, ecstasy, cocaine or heroin. You won’t see any Tinseltown testimonials about coke being the perfect pick-me-up after a hard day on the set. The more negative the ad, the better. Why you can even imply that all illegal drugs are equally dangerous. For some strange reason most of these ads focus on marijuana, which is the least dangerous mind-altering drug -- legal or illegal. The other recreational drug advertised on TV is alcohol. Now alcohol is alcohol, whether it comes in a shot of whiskey, a glass of wine or a can of beer. Nevertheless, the networks decided long ago not to accept ads for liquor, only beer and wine. Don’t ask me why. A while ago I said it’s the job of the FDA to require pharmaceutical makers to describe the risks as well as the benefits of their drugs. Well, even though alcohol is a drug and the “D” in FDA stands for “Drug,” the FDA does not regulate ads for beer and wine. Now that could be because alcohol isn’t as dangerous as Claritin. No, wait a minute. It couldn’t. Even though the “D” in ONDCP stands for “Drug,” that office doesn’t regulate beer and wine ads. Nor does ONDCP include alcohol in its “anti-drug” ads. Now that could be because alcohol isn’t as dangerous as marijuana. No, wait a minute. It couldn’t. Why even Barry McCaffrey, the pot-obsessed former drug czar, calls alcohol the “most destructive drug in America.” Anyway, the Federal Trade Commission oversees alcohol advertising. Did I say oversees? I meant overlooks. Once in a blue moon it will take a company to task for blatantly unfair or deceptive ads, but the FTC believes “self-regulation” is best for brewers and wine merchants, who couldn’t agree more. The brewers drew up a hard-hitting voluntary code that permits them to run ads on shows where 49.9 percent of viewers are under the drinking age and to use humor and animated characters that appeal to kiddies -- so long as the humor and characters also appeal to 21-year-old frat boys. Beer ads accentuate the positive. Make no mistake, there is a positive side: It’s a tasty beverage that gives shy guys the courage to talk to pretty gals. If you use good judgment you can enjoy it in good health for a lifetime. But somewhere in the ads you’d think a conscientious corporation would insert the words “drug,” “addictive” and “cirrhosis,” or remind women that fetal alcohol syndrome is the leading cause of birth defects. Maybe tell kids and teens they can die from an overdose, and that alcohol is a prime factor in the leading causes of death for young people -- not just drunk driving, but drownings, falls, homicide and suicide. Alcohol is, by far, our most widely abused mind-altering drug. Yet beer commercials give viewers the impression everybody drinks -- white guys who throw sofas out of third-floor windows and black guys who say “Whassup,” not to mention dogs, frogs, lizards, lobsters and beavers -- and no one ever develops a problem. Brewers are a lot like Norman Vincent Peale: They believe in the power of positive advertising. So, fellas, those are the standards. Now which drug would you like to push? The end