Sick of Drug Ads for Meds? The Rules Are About to Change

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<p>If you watch any type of live television, or even streaming services with drug ads, chances are you’ve seen them. Entire ensembles, in coordinated colorful costumes, moving in perfect sync, choreographed, singing, and parading through the center of town (or an office building, for some reason) loudly and proudly singing about their newly lowered A1c. </p>
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<p>Sure, they mix it up, too. Sometimes they are dancing through the farmer’s market, mountain biking across trails, or giggling through a mimosa brunch. Prescription drug ads abound, through all hours of the day, during all types of television shows. But, they’re seldom filled with the reality of the medications they are promoting.</p>
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<p>The United States, allowing such ads at all, is actually unusual among the rest of the world’s countries.</p>
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<p>“The U.S. and New Zealand are the only countries that allow direct-to-consumer prescription drug advertisements,” says Dr. Neeraj Sood, PhD, in a <a href="https://www.usc.edu/" target="_blank" rel="noreferrer noopener">University of Southern California</a> (USC) <a href="https://healthpolicy.usc.edu/article/should-the-government-restrict-direct-to-consumer-prescription-drug-advertising-six-takeaways-from-research-on-the-effects-of-prescription-drug-advertising/#:~:text=The%20U.S.%20and%20New%20Zealand,to%2Dconsumer%20prescription%20drug%20advertisements." target="_blank" rel="noreferrer noopener">Leonard D.Schaeffer Center for Health Policy and Economics review</a>. “In the U.S., television viewers are subjected to an especially increasing volume of drug commercials. In 1996, $550 million was spent by pharmaceutical companies on drugs ads. That number increased more than 10-fold by 2020, reaching <a href="https://www.fiercepharma.com/special-report/top-10-ad-spenders-big-pharma-for-2020" target="_blank" rel="noreferrer noopener">$6.58 billion annually</a>.” </p>
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<p>That’s a lot of money spent trying to get you to know about a drug before you even get to your doctor’s office. Let’s take a deeper dive into these ads, and the new rules coming to regulate their format, and if they go far enough.</p>
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<h2 class="wp-block-heading">Regulation of U.S. Drug Ads</h2>
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<p>The <a href="https://www.fda.gov/" target="_blank" rel="noreferrer noopener">Food and Drug Administration’s</a> (FDA) <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-frequently-asked-questions-faqs" target="_blank" rel="noreferrer noopener">Office of Prescription Drug Promotion (OPDP)</a> has finalized a ruling for “CCN” or the “<a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-frequently-asked-questions-faqs" target="_blank" rel="noreferrer noopener">Clear, Conspicuous, and Neutral</a>” advertising. Besides a mixture of alphabet soup, what does this mean? Designed to go into effect May 20, 2024, but with allowances until Nov. 20, 2024 for compliance, the new “rules” will apply to any radio or television prescription drug ads referred to as DTC, direct-to-consumer. </p>
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<p>(Fun trivia factoid, the Federal Trade Commission (FTC) oversees advertising  over-the-counter drugs (OTC), the FDA handles regulation on prescription ads)</p>
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<p>“The FDA believes that this approach will enable firms to bring DTC TV/radio ads subject to the final rule into compliance with the rule, regardless of where those ads may be in their lifecycle,” explains <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-frequently-asked-questions-faqs" target="_blank" rel="noreferrer noopener">an FDA-released FAQ</a> on the new changes. (Are you lost in the letters yet?)</p>
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<p>Those making ads ahead of the deadline can request for them to be reviewed for compliance, but it will not be a required process until the final deadline. For now, it remains a “voluntary request for advisory comment.”</p>
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<h3 class="wp-block-heading">What Is the OPDP?</h3>
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<p>A division of the FDA, this office focuses exclusively on DTC ads. It will oversee the new regulations and be charged with keeping drug companies accountable once it is fully in place.</p>
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<p>“OPDP protects the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated,” says <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp" target="_blank" rel="noreferrer noopener">the OPDP’s mission statement on its website</a>. “This is accomplished through comprehensive surveillance, compliance, research, and education programs, and by fostering better communication of labeling and promotional information to both healthcare providers and consumers.”</p>
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<p>In my opinion, I am unclear what part choreographed dancers around a town’s fountain is “truthful, balanced, and accurately communicated,” but I’d like to think the new changes will help in this matter.</p>
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<h3 class="wp-block-heading">What Rules Are In Place Now?</h3>
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<p>Prior to the new CCN rules, the OPDP already had some rules in place for all types of drug ads. Dubbed the <a href="https://www.ncbi.nlm.nih.gov/books/NBK585046/" target="_blank" rel="noreferrer noopener">Federal Food, Drug, and Cosmetic Act (the FD&C Act</a>, because you know you wanted more acronyms), these preexisting general guidelines included requirements, such as that the ad include “information in brief summary relating to side effects, contraindications, and effectiveness.”</p>
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<p>In other words, an ad already must explain the side effects that may occur in a prescription drug advertisement. </p>
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<h3 class="wp-block-heading">What Changes Are About to Go Into Place?</h3>
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<p>The final rule on DTC advertising outlines five key standards which all future ads must comply with in order to be distributed. The main purpose of the changes is to create rulings in which advertisements must adhere to presenting any major statement about a medication. That statement (what the drugs does) must be three things: Clear, Conspicuous, and Neutral.</p>
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<p>Needless to say, these three words will be open for much interpretation.To help us all to understand the CCN update, the OPDP outlined five key standards.</p>
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<h2 class="wp-block-heading">Five Key Standards of CCN</h2>
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<p>To best understand how the new regulations will be implemented, we will break down the five key standards the ruling has outlined.</p>
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<h3 class="wp-block-heading">1. ‘Major Statements’ Must Be Presented in ‘Consumer-Friendly’ Language</h3>
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<p>Advertisers must ensure the language is “readily understandable.” The average person must be able to understand what is being said in an ad. What good would regulations be if medical terms that no one understands are used in ads?  Important information would go over every consumers’ head. </p>
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<p>To help the basic viewer understand, advertisers must avoid advanced medical jargon and instead are required to use basic language. Ads cannot be aimed to “trick” buyers, or use words they will struggle to understand.</p>
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<h3 class="wp-block-heading">2. Audio Information Must Be Understandable</h3>
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<p>Here’s another step that should be pretty obvious. You can’t jumble your words, read them at a rapid pace, or change the volume in order to squeeze them in and/or make them difficult to understand. I’m sure you can hear this now, just Imagining the last drug ad you’ve seen you’ll remember the part where a narrator suddenly speed reads the side effects under his breath.  There is a clear change noticeable to consumers, different from the entire ad’s vibe, as if to say “blah, blah here’s the stuff they make us say.” Per the final rule, this will no longer be permitted.</p>
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<h3 class="wp-block-heading">3. Text Must Be Presented in a Clear, Conspicuous, Neutral Manner</h3>
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<p>In addition to the CCN descriptions, this step of the final rule noted that ads must show information in “dual modality.” This fancy term simply means the ad must show visible text as well as play auditory descriptions (verbally speak) at the same time.</p>
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<p>Text must also be displayed, and words audibly spoken, at a pace/length of time to allow a consumer to read/hear it clearly. In other words, no flashing the side effects in ridiculously small “fine print” at the last millisecond of an ad. Instead, key phrases and words must be shown clearly, allowing the consumer to understand what is being said and shown.</p>
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<h3 class="wp-block-heading">4. Text Information in Drug Ads Must Be Readable</h3>
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<p>Aligning with the third key factor, all text shown in an ad must be clear to the consumer. Take television ads for instance. Sitting at an average distance from the television, I cannot even read the “guide” most of the time, since the font is so small, and I am becoming increasingly nearsighted with age. I’d have to get up and walk up to the TV if I wanted to read the text. </p>
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<p>The same concept is now being addressed in prescription drug ads. That itty bitty fine print isn’t going to cut it. I don’t have time, even at my middle age, to get up and read that in a 60-second ad. So, now drug companies must make it fair and realistic for me to actually read the words on the screen. Again, a quick flash of fine print near the ad’s end will no longer be acceptable.</p>
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<p>Ads will need to use a set text size, keep the words on screen a set amount of time, and use a color contrast that is easy to read.</p>
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<h3 class="wp-block-heading">5. Ads Must Not Include ‘Distractions’</h3>
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<p>For me, this one is almost laughable. Aren’t all drug ads a massive distraction? You aren’t seeing someone throwing up several times a day.. You see a woman gleefully dancing and serenading us about her newly lowered A1c. I will personally be pretty interested to see how “distractions” will be interpreted by ad agencies.</p>
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<p>The technical language of this key factor states “a major statement may not include distracting representations that detract from the communication of the major statement.” The ruling does not prohibit music, loud sounds, or choreography, sadly, but instead simply says that these things must not play OVER the description of side effects or warnings.</p>
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<h2 class="wp-block-heading">What These Changes Are Aiming to Improve?</h2>
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<p>The FDA is aiming to bring clarity and understanding to prescription drug ads. In my opinion, while the rules above are certainly a step in the right direction, if we continue to allow DTC advertising of prescription drugsNonetheless, I’d prefer that we ban the ads entirely, so we wouldn’t need such regulations.  Unfortunately,t I also doubt our money-focused economy and multi-billion dollar drug companies that will happen in my lifetime. So, if ads are to remain, is this a big change?</p>
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<p>In one way, yes, I would say these updated key factors will make it more difficult for advertisements to trick or fool consumers into ignoring the real risks that come with prescription medications. Things that, well, ought to have been common sense and basic ethics, are now a requirement. It’s almost as if the FDA decided to elaborate and enlarge its own “fine print.” Most of these, to me, sound like “OK, let us be more clear, because we thought these things would be obvious.” </p>
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<p>Some are heralding these as a great step to protect consumers. I, personally, think they should have done a whole lot more. This, in my mind, is simply a clarification of rules that should have already been in place. If it were up to me, ads would be banned altogether. Consumers should not be influenced or persuaded to use a certain drug based on commercial exposure. You should be selecting medications, if and when you need them, by working closely with your doctor, weighing options after educating yourself with unbiased information, and making a selection that is the healthiest choice for your body.</p>
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<h2 class="wp-block-heading">My Unasked For $0.02</h2>
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<p>A phrase I use often, offering my proverbial “two cents,” whether I am asked or not, isn’t just a cute term; it is a favorite pastime. As an employee of a nonprofit organization dedicated to informing all about the side effects of medication, I have an added responsibility to offer said pennies, especially if I worry about the safety of our readers.</p>
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<p>In this case, I hope these rules do as I imagine the FDA and OPDP intend: make ads safer, easier to be understood, and create informative, clear delivery of truthful benefits and risks of meds. Selecting a drug should be an in-depth conversation you have with your doctor. It should be based on your condition, your symptoms, your needs, and your life. It should be a talk in which you weigh the pros and cons, the potential benefits of the medication, along with its potential risks or harm. That is the level of thought and consideration with which a new medication, which no matter how it is consumed will impact every part of your body, should be weighed. </p>
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<p>Even if a well-meaning, descriptive, and informative ad (if one ever existed) could be created, it will never replace the in-depth research, understanding, and consideration that a medication warrants before entering your body. No amount of regulations will ever likely “make me happy” or feel better about the FDA protecting us; not until ads are prohibited for good. </p>
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<p>Choosing a drug, or whether or not to take it at all, is your decision. It is a choice that should be made with an educated, informed, and unbiased set of facts.</p>
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<p>It shouldn’t be because you saw a colorful, choreographed, 60- to 120-second musical between Wheel of Fortune and Jeopardy.</p>
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