Direct To Consumer Drug Advertising - The Good, the Bad, and the Ugly

Direct to Consumer Pharmaceutical Advertising (DTCPA) is a fancy name used to describe the effort by pharmaceutical companies to promote prescription drugs directly to consumers (better known as patients). If you haven’t been living under a rock, you’ve probably seen a big pharma drug commercial or two (or three or four). Let’s talk about the pros and cons of DTCPA, but first, a brief background. 

Brief History of DTCPA

Travel to most of the world, and you may never see a prescription drug commercial. In fact, the United States and New Zealand are the only two countries in the world that allow DTCPA with product claims

Drug advertising is nothing new. To stop a free fall of ads claiming miracle drugs, The Food and Drug Administration (FDA) regulates them. They began regulating prescription drug labels and advertising in 1962 but started refining those regulations shortly after. During the first few years, drug manufacturers focused most of their advertising dollars on doctors. In the mid-1980s, everything changed. Pharmaceutical companies realized they could advertise directly to consumers as long as they followed those 1962 regulations and spelled out all the drug risks. But that didn’t last long. 

The first direct-to-consumer ad ran in print in Reader's Digest in 1981, and that was the beginning of the drug advertising era. In 1997, the FDA reduced restrictions for broadcast media, allowing drug advertisers to include only “major risks” in advertising. In 2004, the FDA further relaxed regulations, allowing pharmaceutical companies to replace the fair balance summary with a simplified brief summary.  According to Johns Hopkins, “since 1996, annual direct-to-consumer advertising budgets for prescription drugs have increased from $1.3 billion to, in 2016, $6 billion.”

At first glance, DTCPA sounds like it gives the patients more acess and more education, but there is a reason only two countries in the world allow it. Some argue that the FDA loosened too many restrictions. When thinking about the pros and cons of DTCPA, they do come with benefits.

DTCPA - The Good

Information is valuable, and pharmaceutical advertisements allow the public to access information about medication use, which is a good thing in theory. 

Pharmaceutical lobbyists have tried to pass legislation in other countries that would allow limited medication information to patients. They failed. The consequences of that continue to leave consumer patients in the dark about their treatment options. 

Here in America, DTCPAs created a cultural shift that allowed patients to start actively participating in their medical decision-making. With more information, they have more power over the treatment of their medical conditions. 

Drug advertisements also encourage patients to contact their physicians and open a dialogue about their healthcare journey. These ads reduce underdiagnosis and under-treatment, as well as reducing stigma around sensitive health issues. Remember when everyone was afraid to say the C word? The more the mainstream media spoke about cancer and cancer treatments, the less stigmatizing the diagnosis became.  

But there’s a reason DTCPAs are banned in nearly every other country in the world.

DTCPA - The Bad

In response to this cultural shift in the U.S., pharmaceutical companies saw dollar signs and drastically increased consumer advertising. In 2021 alone, Big Pharma spent $6.88 billion on direct-to-consumer advertising. 

All of this pharmaceutical advertising has negative consequences

First, although advertisements for medication are supposed to educate patients, they often leave them feeling confused and misinformed. DTCPAs tend to overemphasize drug benefits and minimize drug risks. Further, they tend to promote new drugs before safety profiles are fully known. The problem is that consumers are often woefully unaware of this fact and just assume the drug is safe if they see it on TV. 

Drug advertising can also lead to inappropriate prescribing and drug over-utilization. Let me stop here to share a story… 

DTCPA - The Ugly

In 1996, Purdue Pharma began aggressively marketing a new drug they brought to the market: OxyContin 

The drug's first purpose was to help cancer patients fight pain. It worked—really well. Purdue saw profit margins and began telling sales reps that their bonuses would be calculated based on OxyContin numbers. There weren't enough cancer patients to go around so their target market shifted to non-cancer patients.

“Your priority is to Sell, Sell, Sell OxyContin,” one memo said

By 2001, OxyContin was generating both enormous profits as well as growing concern. People spoke up, but Purdue hit back.

Purdue contested hundreds of lawsuits, winning dismissals or settling cases with the provision that documents remain secret. 

Fast forward a couple of years and more than 100 billion doses of opioids flooded the country between 2006 and 2014. Some towns were left completely destroyed. Over a 10-year period, nearly 21 million prescription painkillers flooded two pharmacies four blocks apart in a West Virginia town with a population of 2,900. To this day, Americans are still reeling from the impact of a national opioid crisis.

Purdue is finally answering for its actions. Its answer? Bankruptcy. A federal bankruptcy judge approved a $8.3 billion settlement just this year. But the settlement payments don’t necessarily stop pharmaceutical companies from repeating their actions. According to market research, the worldwide pharmaceutical market was worth nearly $1.3 trillion in 2019. A billion-dollar settlement doesn’t do much these days. 

The Answer? Education and Regulation

From 1999 to 2018, 232,000 Americans died from overdoses of prescription opioids, according to the CDC. Americans didn’t have to die if there had been some oversight of Purdue’s drug marketing efforts. 

So, what can we do? Some will argue to ban DTCPAs completely. Others would prefer to not do anything at all, and let big pharma run wild. However, it is this type of action that left hundreds of thousands of Americans dead from Opioid Addiction. 

There have periodically been calls for the FDA to curtail or ban DTCPA. However, free speech arguments almost always win out. Product advertisements are considered a form of “commercial speech,” and banning or restricting commercial advertising violates the First Amendment. It’s a tricky hill to climb legislatively and is ultimately up to the FDA to refine regulations. 

In the absence of better oversight, we can increase and improve education around the pros and cons of DTCPA. The most important thing that consumers should remember about drug ads is that they are just that—advertisements. Their primary goal is not to help the consumer, but to sell the product. Education and advocacy are key to protecting consumers and creating change.

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