What are all those drug ads saying?

Why are all those smiling people talking about bad drug side effects on TV?
We are now all familiar with seeing drug ads on TV that talk about all the benefits and risks of prescription drugs. These commercials have become the common butt of many jokes to see a bright smiling attractive-looking face talking so openly about the diseases and medical problems they're suffering from and the medications they're taking. The commercial actors speak so comfortably about the various potential side effects the drug may cause such as nausea, vomiting, muscle aches, burning sensations, etc., etc. Each prescription drug commercial is almost formulaic: 1) Smile at camera, 2) mention what illness you have, 3) talk about how this drug has helped you, 4) tell people about a list of potential side effects, and 5) tell people to ask their doctor about more information.

The reason these commercials are so formulaic-looking is because they are. There is actually a set of rules that tell drug advertisers what they can (and can't) say in prescription drug advertisements. So who makes these rules and what are they? That is the topic of this blog.

Who makes the rules?
There are 2 types of drug classifications based on how you are able to obtain the drug. Prescription Only drugs (which I'll simply refer to as prescription drugs) can only be obtained by prescription from your health care professional (makes sense given the name). This is in contrast to Over-the Counter drugs that can be purchased at pharmacies or other stores without a prescription. The Food and Drug Administration (FDA) regulates the manufacture, distribution, and sale of both classes of drugs in the US. However, the FDA only regulates prescription drug ads. Advertisements for Over-the-Counter drugs are regulated by the Federal Trade Commission (FTC). Our focus is on prescription drug ad rules and regulations, therefore we will focus on the FDA.

The FDA's main goal regarding prescription drug ad regulations is to ensure that drug companies provide information in their advertisements that is truthful, accurate, and balanced regarding the positive and negative drug effects. Remarkably, the FDA typically does not require prescription drug ads to be reviewed and approved prior to their public use. Rather, the FDA often reviews these ads after they have already started being used. There is an FDA division called the Division of Drug Marketing, Advertising, and Communications (DDMAC) that monitors these prescription drug advertisements. This job was a lot easier prior to the mid-1980s when the drug advertisement landscape drastically changed.

How do drug companies advertise their drugs?
Prior to the mid-1980s, drug companies advertised prescription drugs only to health care professionals (HCPs), such as doctors and pharmacists. The HCPs then relayed that information to their patients to whom the drugs were being prescribed. However, during the 1980s, some drug companies started to advertise directly to the public, an approach refered to as Direct-to-Consumer (DTC) advertising. DTC ads changed everything. They were and continue to be highly controversial. Because of the controversy, many drug companies abide to a moratorium on DTC advertisements for six months after a new drug comes to market. The US Congress is currently asking drug companies to agree to a two year moratorium on DTC ads, but no companies have taken them up on the offer.

With the advent of DTC ads, drug companies now have multiple ways of marketing their drugs. A few things they need to consider are:

Who is the target audience of the ad?
Drug companies now have 2 different audience groups to consider: 1) the HCP (e.g., the doctor), and 2) the patient (i.e., the consumer). There are different FDA rules based on which of these audiences is being targeted.

When will the ads be used?
The drug company can choose to advertise the drug before the actual FDA approval to sell the drug. These ads are known as pre-approval ads. Drug ads that are used after the actual FDA approval to sell the drug are known as post-approval ads. There are different FDA rules for pre-approval ads versus post-approval ads.

Where will the ads be used?
Drug companies can advertise in many locations. Pamphlets and brochures can be placed in the doctor's office. This type of media distribution is part of what's called promotional labeling which is often treated differently from advertisements. Drug advertisements tend to be either in print (e.g., magazines, newspapers) or broadcast media (e.g. TV, radio). There are different FDA rules for print ads versus broadcast ads.

Will the ad mention the drug's name?
This may seem like a strange question? Why wouldn't the ad mention the drug's name? Well, for reasons we'll address in a moment, the drug company may not want or, as we'll see, may not be allowed to mention the drug's name. An advertisement that does mention the drug's name is called a branded ad. An advertisement that does not mention the drug's name is called an unbranded ad. (As a side note, pre-approval drug ad campaigns cannot use both branded and unbranded ads, so marketing departments must carefully plan their promotions.)

Product Claim Ads
A familiar type of branded ad is the Product Claim Ad. Product Claim Ads not only name the drug but also discuss its benefits and risks. This is the type of ad that probably comes to mind when you think of a TV drug ad. The FDA requires that Product Claim Ads not be false or misleading and must be understandable by the average person
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Product Claim Ads, whether they appear in print or on TV, must include the following key components:
1) The drug's name. This must include both the brand name (i.e., the drug company's proprietary name) and the generic name (the non-proprietary name).
2) The drug's FDA-approved use
3) The drug's most significant side effect risks. These risks must be stated in a balanced manner relative to the drug's benefits.
4) a statement that the drug is obtained by prescription only (remember, we are dealing with prescription drugs. Over-the-counter drugs are regulated by the FTC).

Drug companies are prohibited from advertising any drug benefits that have not been approved by the FDA for that drug. Interestingly, doctor's are allowed to prescribe a drug for uses other than the FDA-approved use. This Off-Label prescribing is a highly controversial issue, but will await a future blog.

In Product Claim Ads, drug companies must provide the consumer access to lots of details about the FDA-approved usage of a drug. These FDA-approved drug details are contained in the drug's Prescribing Information. This information can be found as a document in the drug's container known in the US as the Package Insert (PI).

The prescribing information includes lots of details about the drug including:
1) the drug's chemical description
2) the FDA-approved drug use (i.e., what medical condition does the drug help)
3) the drug's method of action (i.e., how it is believed to work)
4) the drug's interactions with other drugs, health supplements, or foods
5) who should not use the drug (e.g., children, pregnant women)
6) the drug's side effects, both serious and non-serious risks even if they may be rare. Risks that may lead to death or serious injury may have the warning information displayed within a black-bordered box. Such a warning is referred to as a Boxed Warning or a Black Box Warning.

So how does the drug company put all of this information into its ad (and still get you to be interested in buying the drug)?
The FDA ad rules for Product Claim ads are slightly different depending on whether the ad is printed or broadcasted

Print ads must include a Brief Summary of all the prescribing information listed above. The Brief Summary is usually on a separate, but adjoining page to a nice colorful ad page with lots of pretty graphics to catch your eye. Check this out next time you see a Product Claim ad in a magazine and you'll find this Brief Summary page next to every main drug ad page (if you don't, you can report it to the FDA because it would otherwise be illegal). The Product Claim ad will often also provide sources of further drug information, such as a website and toll-free telephone number. In addition to the Brief Summary, the FDA requires that all print media Product Claim ads include the exact statement "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088." (again, look for this next time you see a Product Claim ad in a magazine...go ahead, it will be fun.)

Broadcast Product Claim ads must meet what the FDA calls Adequate Provision when providing drug information. Broadcast Product Claim ads do not have to state as much drug information as print ads do. This makes sense because it would be costly, time consuming, and not very welcoming if the broadcast ad had to tell you all the Brief Summary details. Believe me, you would turn the TV channel before the actor even got close to being done.

Instead of a Brief Summary, broadcast ads just have to provide what's known as the Major Statement. The Major Statement presents just the most important risks that the drug presents. The Major Statement may be provided as text in the TV video, but it must be spoken. So this is why that smiling actor on TV is telling you about the drug's main side effects. They are giving you the requisite Major Statement of the drug. This Major Statement helps the drug company fulfill the FDA's Adequate Provision requirement, but it is not sufficient. In addition to the Major Statement, the drug company must provide ways that the listener (radio) or viewer (TV) can find the drug's FDA-approved prescribing information. This may include a toll-free phone number, a website, a magazine containing the print version of the ad, or a recommendation to ask your doctor. So now you know why the actor keeps recommending you speak to your doctor ... they are fulfilling the Adequate Provision requirement.

So that's a lot of information that drug companies need to know about advertising their drug. But that just covers Product Claim ads. There is another type of Branded Ad that doesn't need so much detailed information. This is known as the Reminder Ad.

Reminder Ads
Reminder ads give the name, but not the use, of the drug. Remember, the Product Claim ad claimed how the drug is to be used. So why in the world would a drug company spend the money on an ad that doesn't even tell people what to use it for?

The Reminder Ad is used when the drug company assumes that the consumer already knows what the drug is for and simply needs to be reminded of the drug's name. Reminder Ads do not contain any drug risk information since they do not discuss the use for the drug. In fact, Reminder Ads cannot suggest in any way (graphically or in words) what the drug's use is. If they do, they become Product Claim ads and must follow the rules outlined above.

Like Product Claim ads, Reminder Ads must include both the brand name and the generic name of the drug. Reminder ads cannot be used for drugs with a Black Box Warning.

Coming Soon Ads
While Reminder Ads are released post-approval to remind a consumer about a drug, Coming Soon Ads are used pre-approval to let healthcare providers know that a drug is coming to market (assuming it gets FDA approval). Coming Soon Ads, like Reminder Ads, do not contain any drug use information, but may contain the drug's name, logo, and company. They are used to start getting doctors and pharmacists familiar with a drug's name, even if they don't know yet how it will be prescribed. Since the drug has not yet been FDA-approved, Coming Soon ads are limited to healthcare providers as a target audience and cannot be targeted to consumers.

Help-seeking Ad
As mentioned before, some ads are unbranded ads, namely they do not mention the drug's name. You can imagine that if you don't even mention the drug's name, you don't have to provide the drug's prescribing information or risks. One such unbranded ad is known as the Help-seeking Ad. A Help-Seeking Ad describes a disease or medical condition but does not recommend or identify any specific drug to help the condition. Help-seeking Ads can include the drug company's name and provide a telephone number or website to contact for more information. The FDA does not regulate these ads (as long as they obey the simple rules mentioned). Instead, they are regulated by the FTC.

And Now You Know:
So now you know some basics of drug advertisements and how they are regulated. You now can be on the lookout for ad components such as the Brief Summary and FDA contact wording in print Product Claim ads. You can listen for the Major Statement, "ask your doctor", and other Adequate Provision components the next time you see a Product Claim ad on TV.

I hope this blog has given you a little insight into the wizard behind the curtain. So next time you see a drug ad, look or listen a little longer than you did before and revel in the joys of knowing a bit more about why all those smiling actors are so happy to share their medical risks with you.