How Is Consumer Drug Advertising Regulated in the United States?

Have you noticed that TV drug commercials almost never talk about prices? This, along with ongoing anger about rising drug costs, prompted the Trump administration to enact a rule that will require drug manufacturers to disclose list prices of medications in commercials starting this summer—a rule that drug makers are now fighting.

The regulation of drug advertising in the U.S. has long been a source of conflict, though. For almost four decades, drug manufacturers and policy makers have been debating details like whether ads should be approved before distribution and what they need to disclose about the safety and effectiveness of drugs.

So, where are we now with drug advertising regulations? Let’s look at some facts below.

The U.S. is only one of two countries in the world where direct-to-consumer advertising of prescription drugs is legal.

Consumer drug advertising is uncommon globally. The United States and New Zealand are the only two countries in the world where direct-to-consumer (DTC) advertising of prescription drugs is legal. DTC drug advertising is where pharmaceutical companies present drug information to the general public through lay media.

Drug makers spend more and more on TV ads each year.

Pharmaceutical commercials have been running on TV since the late 80s, and every year since, drug makers have increased their ad spending, more than doubling it in the last five years alone. In 2017, DTC ads exceeded $6 billion in spending.

The FDA has rules for what drug ads MUST tell consumers.

The FDA requires ads to follow certain criteria:

• Not be false or misleading

• Present a fair balance of risk and benefit information

• Include facts that are material to the product’s advertised uses

• Include a brief summary of every risk described in the product’s labeling

According to the FDA’s website, that means that drug ads are required to tell us consumers three things:

1. At least one approved use for the drug

2. The generic name of the drug

3. All the risks of using the drug (or under certain circumstances, only the most important

Drug makers can choose whether or not to disclose other information, including prices, in TV ads.

If a drug only worked on a few people, would that affect your decision to use it? Maybe. But drugs ads don’t have to tell us how many people the drug has helped. Likewise, ads don’t need to tell us if other treatments exist or if other treatments have fewer side effects. They don’t even need to tell us if the drug is necessary or if changing simple lifestyle habits could be just as effective.

Depending on how current lawsuits against the Department of Health and Human Services unfold, we may see drug prices in commercials as soon as this summer. But as of this publication, drug ads aren’t required to tell us a drug’s price, if insurance plans will cover it, or if there’s a cheaper generic version or older medication that works just as well.

The FDA does NOT review all drug ads before they are released.

Before airing commercials, many manufacturers voluntarily submit them for clearance from the FDA to avoid having to withdraw them later, but it’s not required. Generally, the FDA does not review ads before we see them and only regulates ads after they’ve been distributed—meaning false drug information could reach you before it reaches the FDA.

Advertised drugs are not necessarily safe.

In most cases, the FDA does not ban companies from advertising any prescription drugs, even ones that have serious risks. (However, some states do bar controlled substances from being advertised.)

On top of that, it’s possible for drugs to be promoted before they’ve been fully tested to be safe. We saw this happen with Vioxx, a blockbuster painkiller marketed from 1994 to 2004. Merck spent over $100 million per year to advertise Vioxx, and patients requested it from doctors not knowing it could cause strokes or heart attacks. Finally, in September 2004, after numerous safety issues came to light, Vioxx was withdrawn from the market.

Drug ads tend to omit important risk information and overemphasize benefits.

Here are some of the most common ways advertisers make drugs seem more helpful than they really are:

• Showing a person enjoying life outdoors while the narrator reads side effects in the background

• Listing the most serious side effects of a drug toward the end of the commercial to make you think they’re less common than they are

• Using subjective terms like “mild” or “may” to describe a risk to make the risk seem less dangerous than it is

Also, know that even though risk information is presented in ads, it may not be complete. The FDA allows drug companies to omit risk information in certain ads, as long as we’re told where to find that information (like on a website or at a doctor’s office).

You can submit complaints to the FDA.

In the U.S., the Office of Prescription Drug Promotion (OPDP), a body within the FDA, reviews drug advertisements. If you see any commercial that you think is false, misleading or biased, you can report the ad to the OPDP by calling 1-301-796-1200.

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As you can see, it’s important to take the information you get from drug commercials with a grain of salt, and to be aware of the fact that crucial information like risks, other options, and costs are not always clear. If you have any questions about new medications, consult your doctor or another healthcare provider to learn more.