history-drug-adsMom, I know you might have freaked out a bit when you read that headline. But don't worry! The whole "Say 'Yes' to Drugs" bit isn't me advocating for drug use: I'm just making a tongue-in-cheek reference about pharmaceutical marketing messages.

Ultimately, pharmaceutical companies do want consumers to say "yes" to drugs -- their drugs.

And, as you're about to discover, these companies have used a variety of marketing tactics over the years in order to get consumers to say "yes." 

Now -- to be sure -- this is a heavily debated subject, especially when we hone in on direct-to-consumer pharmaceutical marketing (which will be the main focus of this article). And all I mean by "direct-to-consumer" is that marketers aren't appealing to doctors or health care organizations with their marketing messages: They're targeting people/patients directly.

With the direct-to-consumer approach, pharmaceutical companies aren't saying, "Hey, doctors, this drug would be great for your patients!" Instead, they're saying,"Hey, patients, this drug is great! Go tell your doctors about it!"

Direct-to-Consumer Drug Ads: Evil or Informative?

From the viewpoint of the pharmaceutical companies, direct-to-consumer marketing is advantageous for consumers. They argue that it helps to educate patients about different drug options, it encourages patients to get in touch with -- and have a dialogue with -- health care providers, and it helps to reduce the under-diagnosis (and under-treatment) of medical conditions.

Detractors would counter, however, that direct-to-consumer marketing often leaves patients misinformed, that it over-emphasizes the benefits that drugs provide, and that it leads to the unnecessary prescribing and over-utilization of drugs. Furthermore, the opposition contends that this type of marketing can strain patient/doctor relationships. (Just imagine someone watching a 30-second commercial and then trying to convince a doctor -- with 30 years experience -- that taking X drug is the best course of action.)

So, which side is correct in their assessments of direct-to-consumer pharmaceutical marketing? That's not for me (or this article) to say. Instead, I'm going to focus on the history of pharmaceutical marketing, and explore how we went from simple print ads to the side effects-filled TV spots that we know (and mock) today.

But first, here's a quick breakdown of the different types of drug ads that pharmaceutical companies produce. Getting familiar with these ad types will help you better understand how (and why) the government would eventually start regulating pharmaceutical marketing.

Types of Drug Ads

Today, the FDA recognizes three specific types of drug ads: Help-seeking ads, reminder ads, and -- the most common variety -- product claim ads.

Pharamaceutical-ads

Help-Seeking Ads

Ever see one of those drug commercials where the voiceover narration doesn't really talk about the actual drug, but instead focuses on describing the symptoms of a condition? Then, at the end, it encourages you to talk to your doctor? That's your classic help-seeking ad.

When produced correctly, help-seeking ads don't make any claims about the efficacy of a drug or about the benefits a drug provides. And, for that reason, the FDA doesn't regulate them. That means help-seeking ads aren't required to list out risks or side effects.

Reminder Ads

According to the FDA, reminder ads can include information about how strong a drug is, how much it costs, and what dosage form it comes in (e.g. pill, spray, inhaler, etc.). However, the ads cannot include any information about what a drug does or how it works. This is the case for both words and images.

For example, if you were creating a reminder ad for a heart medication, you couldn't show an image of a heart, as that would imply what the drug does. Like help-seeking ads, reminder ads aren't required to list risks or side effects.*

*With the exception of particular prescription drugs with serious risks, like serious injury or death. These drugs always have to display a warning (called a "boxed" or "black box" warning).

Product Claim Ads

These are the drug ads we all know and love ... or hate ... or love to hate? Whatever the case, product claim ads have three critical components:

  1. The name of the drug, both its brand name and its generic name. (Fun, slightly random fact: While many of us use the term "Dramamine" to refer to a generic motion-sickness medication, it's actually a brand name. The generic name is "dimenhydrinate.")
  2. An FDA-approved use for the drug.
  3. Significant risks.

Ever wonder why those product claim commercials you see on TV are always chock-full of side effects? They have to be. As the FDA's website tell us, "Product claim ads must present the benefits and risks of a prescription drug in a balanced fashion."

Of course, that wasn't always the case ...

The "Good" Ole Days

Cocaine_tooth_drops

As it turns out,  the good ole days of pharmaceutical marketing really weren't all that good ... at least not for consumers.

Up until the early 1900s, drug companies (and, ya know, random people) could concoct crazy formulas, patent them, and then market them however they'd like. There was zero regulation.

Want to take out an ad in the local newspaper or put up a billboard that claims your magic tonic can cure cholera, diphtheria, dysentery, measles, and rattlesnake bites? (All ailments found along the Oregon Trail, by the way.) Prior to 1906, you could totally do it. And people did do it. 

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Unfortunately for the people living back then, wasting money on a drug that turned out to be ineffective wasn't necessarily the worst of their problems: these unregulated drugs often contained high levels of alcohol, morphine, or other substances -- like mercury and formaldehyde -- that could cause serious harm.

1905: The Great American Fraud

At some point someone had to call B.S. on all those snake oil-salespeople masquerading as medicine makers. Luckily, our free press came to the rescue.

Toward the end of the 19th century and into the early 20th century, journalists began tackling industries that posed a threat to the American public. Unsurprisingly, they soon turned their attention to patent medicines.

One series in particular, "The Great American Fraud," would be instrumental to the eventual passing of regulatory legislation for patent medicines. Journalist Samuel Hopkins Adams wrote the series (comprised of 11 articles) for Collier's Weekly in 1905.

As you can glean from the excerpt below, Adams had some serious misgivings about how the unregulated patent medicine market operated:

"Gullible America will spend this year some seventy-five millions of dollars in the purchase of patent medicines. In consideration of this sum it will swallow huge quantities of alcohol, an appalling amount of opiates and narcotics, a wide assortment of varied drugs ranging from powerful and dangerous heart depressants to insidious liver stimulants; and, far in excess of all other ingredients, undiluted fraud."

Fortunately for the American public, "The Great American Fraud" would go on to attract the attention of a member of the Department of Agriculture, who then pushed Congress to act.

1906: Purification Proclamation

Congress passed the Pure Food and Drug Act of 1906, thanks -- in part -- to the journalism of Samuel Hopkins Adams.

To be sure, many other journalists (and activists and politicians) played a role. The most well-known of which is probably Upton Sinclair, who tore down the meat-packing industry in his novel The Jungle.

The Pure Food and Drug Act forbade, and I quote“the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs or medicines, and liquors.”

It also established federal drug purity levels, and required that manufacturers list a drug's active ingredients on its packaging.*

*The labeling was only mandatory for specified substances/ingredients, including heroin, morphine, cocaine, alcohol, and marijuana. These substances were all still legal at the time, provided drug companies labeled them appropriately.

1911: United States v. Johnson

So it turns out the nice people who wrote the Pure Food and Drug Act forgot to include that bit where it becomes illegal to lie about the benefits a drug actually provides.

There was a Supreme Court case to determine whether or not making "false therapeutic claims" about a drug was legal under the Pure Food and Drug Act.

Ultimately, the Court ruled in favor of making outrageous, unsubstantiated claims. (Yay, America!) It noted that the Pure Food and Drug Act only forbade drug companies from lying about a drug's ingredients; lying about a drug's benefits was still totally cool.

Hence, the ad below was 100% legal when it was published in a newspaper a few years earlier in 1908.

false-drug-ads

1912: "Don't Worry, We Got This" -- Congress

In response to the United States v. Johnson case, Congress passed the Sherley Amendment in 1912, which prohibited false therapeutic claims on drug labeling.

However, there was one, major caveat: To enforce the amendment, the government needed to be able to prove fraudulent intent. And that's a tricky landscape to navigate.

How can you distinguish between companies that are lying about their drugs but think they're telling the truth, and companies that are lying about their drugs and know they're lying?

1927: FDA in the USA

In 1927, the U.S. Bureau of Chemistry split into two separate agencies: the Bureau of Chemistry and Soils, which handled research, and the Food, Drug, and Insecticide Administration, which handled regulations.

(Don't worry, they dropped the "Insecticide" a few years later and became the Food and Drug Administration, or FDA.)

1938: So Long, Sherley

With the passing of the Federal Food, Drug, and Cosmetic Act in 1938, the Sherley Amendment requirement to prove fraudulent intent got the chop. Drug fraud was drug fraud, be it intentional or otherwise.

The legislation also gave the FDA the authority to regulate drugs. Moving forward, before a company could start marketing a new drug, they'd need to get the FDA to approve its safety.

1962: Some Big Changes

Congress passed the Kefauver-Harris Drug Amendments in 1962. As a result, there were some big changes to the world of pharmaceutical marketing.

Big Change #1: Drug companies now had to prove the effectiveness -- and not just the safety -- of their drugs before they could bring them to market. And, after conducting clinical studies in order to prove effectiveness, they had to disclose any serious side effects. It was up to the FDA to review the clinical studies and approve new drugs before they could be marketed.

Big Change #2: The FDA took control of regulating prescription drug advertising and labeling. (FYI: The Federal Trade Commission regulates over-the-counter drug advertising and labeling.)

Big Change #3: Drug companies could no longer market cheap generic drugs as expensive, "cutting-edge" drugs under new brand names. Prior to this change, you could have -- for example -- taken some acetylsalicylic acid (a.k.a. aspirin), given it a fancy new name like "Xylophonafilaflox," and then marketed it as a new, breakthrough pain medication.

These changes would help set the stage for the modern era of regulating pharmaceutical marketing. However, the FDA still had to finalize a few things ...

1969: Laying Down the Law

In 1969, the FDA made some final stipulations in regards to how pharmaceutical companies could market their drugs. There were four "commandments" total, which stated that prescription drug ads must:

  1. Not be false/misleading
  2. Describe the drug's risks and benefits in a fair and balanced way
  3. Include facts that are relevant to the drug's advertised use(s)
  4. Include a summary that mentions all of the risks that are listed on the drug's label

At this point, it seemed like the FDA had everything under control: There were solid regulations in place that prevented drug companies from lying about or otherwise misrepresenting the safety and efficacy of their drugs.

However, when the 1980s rolled around, a new era of pharmaceutical marketing began to emerge.

1981: The Times They Are A-Changin'

Prior to the 1980s, debates surrounding the FDA's regulation of prescription drugs were concerned primarily with indirect advertising (e.g. sales reps recommending drugs to doctors, or drug companies funding continuing education programs). After all, the days of peddling unregulated potions to consumers were, presumably, over.

For all intents and purposes, the Pure Food and Drug Act -- and its subsequent amendments -- had meant the end of direct-to-consumer pharmaceutical marketing.

By the 1980s, however, political and cultural changes would help bring direct-to-consumer marketing back into the limelight. According to an article in the peer-reviewed medical journal Pharmacy and Therapeutics, the 1980s saw a political climate that was "more favorable to the pharmaceutical industry," as well as a cultural shift that "caused patients to start actively participating in medical decision-making with their health care providers."

As a result, the drug companies start going direct.

Merck ran the first major, (modern) direct-to-consumer print ad in Reader’s Digest in 1981. The ad promoted its new antipneumococcal vaccine, Pneumovax.

Pneumovax_drug_ad

FYI: the image above is a more modern print ad for Pneumovax -- I wasn't able to track down the original ad from 1981.

1983: TV Takeover, FDA Makeover

In 1983, Boots Pharmaceuticals ran the first ever direct-to-consumer TV ad for a prescription drug. The ad promoted the lower price of the drug Rufen, which was its brand of ibuprofen (ibuprofen would later become an over-the-counter drug).

Like Merck, Boots Pharmaceuticals was also running direct-to-consumer print ads during this time. And, across the board, drug companies were seeing sales increase as a result of their direct approach.

In response to these changes, the FDA asked the drug companies to observe a "voluntary moratorium" on running direct-to-consumer ads so it could re-examine how pharmaceutical marketing should be regulated.

1985: New Rules, New Tactics

In a notice published in the Federal Register in 1985, the FDA established that it had regulatory jurisdiction over this new breed of direct-to-consumer drug ads. What's more, the FDA made clear that its stipulations about providing a fair and balanced account of a drug's risk/benefits and including a brief summary of potential side effects still applied.

From a print standpoint, this wasn't a big deal at all: Marketers could simply list out risks and side effects in small print at the bottom of an ad.

But for radio ad and TV, buying enough ad time to include all of this mandatory information posed a problem. As a way around this, drug companies in the 1980s started creating reminder ads and help-seeking ads, which -- if you remember from earlier -- weren't subject to the FDA's regulations.

1990: Spending Check

 In 1990, the pharmaceutical industry spent a total of $47 million on direct-to-consumer marketing.

1995: 5 Years Later ...

In 1995, the pharmaceutical industry spent a total of $340 million on direct-to-consumer marketing.

Also in 1995, the FDA held a meeting to discuss lessening the regulations around radio and TV ads. (The main issue here was one I mentioned earlier: including all of a drug's risks and side effects ate up lots of time and money when running radio or TV spots.)

1997: Now With Fewer Side Effects!

1997 brought some good news for pharmaceutical marketers, and some bad news for consumer groups: In response to industry concerns over radio and TV ads, the FDA relaxed its stance on side effects.

While mentioning a drug's side effects in radio and TV ads was still required, going into extensive detail about those side effects was not. These new guidelines effectively negated the 1969 stipulation that drug ads must mention all of a drug's risks.

As of 1997, direct-to-consumer drug ads on the radio and TV only have to mention a drug's major risks and provide an "adequate provision” to direct consumers to where they can find more information.

1998: Spending Check

In 1998, the pharmaceutical industry spent a total of $1.2 billion on direct-to-consumer marketing.

2004: More Love for Pharma Marketing

The FDA extended its "major risks only" policy to print ads in 2004. As was the case with radio and TV ads, this meant that pharmaceutical marketers no longer needed to include all of a drug's risks in direct-to-consumer newspaper and magazine ads. The change also allowed pharmaceutical marketers to use more simplified language, so ads would be easier for consumers to understand.

Also in 2004, a New York Times article shed some light on how much ad revenue prescription drug ads were generating for the three big networks: ABC, CBS, and NBC. Turns out that from January to September of 2004, nearly 29% (or $110 million) of all ad revenue came from drug ads that aired during the nightly news.

2005: Paging Dr. Internet

A 2005 study of more than 6,000 adults showed that nearly 49% of patients would research a potential ailment or medical condition online first, and then consult their doctor. In contrast, only 11% consulted their doctor first.

Clearly, the internet was revolutionizing how consumers got their information, including medical information.

The pharmaceutical companies were by no means oblivious to this fact, as online search and display ads for prescription drugs were growing more and more popular during this time.

2007: Spending Check

In 2007, the pharmaceutical industry spent a total of $5 billion on direct-to-consumer marketing.

Also in 2007 -- as part of the Food and Drug Administration Amendments Act of 2007 -- pharmaceutical marketers had to start including a mandatory statement in all of their direct-to-consumer print ads:

"You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088." 

lipitor-ad-1

2009: FDA 2.0

The FDA took on online drug advertising in 2009, sending out more than a dozen warning letters to pharmaceutical companies who were buying up sponsored search engine links. 

These sponsored links (a.k.a. search ads) typically included the name of a drug, what it treated, and what its benefits were. Notably absent? Risk and side effect information. From a practical standpoint, there just wasn't enough space in a search ad to include it.

In response, the FDA ruled that sponsored links now had to include either the name of the drug or what it was used for, but not both.

For more information on the 2009 crackdown on sponsored links, check out this article from Search Engine Land.

Also in 2009, direct-to-consumer marketing spending for the pharmaceutical industry dropped for the first time since the late 1990s -- from $5 billion in 2007 to $4.5 billion. This was largely due to the 2008 financial collapse and resulting economic slowdown.

2011 - Present: Direct-to-Consumer Continues

Data from a 2011 Pharmacy and Therapeutics article shows that online direct-to-consumer marketing delivers a 5 to 1 return on investment, which is a better ROI than what traditional channels (like TV and print) can offer pharmaceutical marketers.

However, that's not to say that traditional channels are dead. For example, according to that same article, the typical American TV viewer sees as many as 9 drug ads per day. That comes out to about 16 hours of watching direct-to-consumer drug ads on TV per year.

If it were up to the people who actually prescribed the drugs being marketed, however, it'd likely be a different story.

According to a 2013 survey of 140 physicians, 71% of physicians believe that direct-to-consumer pharmaceutical marketing should be either scaled back or eliminated altogether. Furthermore, 74% said that the direct approach over-emphasizes drug benefits, while 63% said that it misinforms patients.

Though doctors don't love direct-to-consumer marketing, it probably won't go away anytime soon. Based on how successful direct-to-consumer drug ads have been for pharmaceutical companies -- and how relatively lax the regulation has been on the ads in recent years -- it seems like direct-to-consumer marketing is here to stay.

Want to learn how to give your traditional marketing strategy a modern update? Download our free guide, Inboundy Outbound: How to Do Traditional Marketing the Inbound Way.

Image credits: Public domain, I Love Graphics, 100 Years Ago Today, Ad Pharm Blog, ProCon.org

This blog post has provided information designed to help our readers better understand the legal issues surrounding the pharmaceutical industry. But legal information is not the same as legal advice -- the application of law to an individual’s specific circumstances. Although we have conducted research to better ensure that our information is accurate and useful, we insist that you consult a lawyer if you want professional assurance that our information, and your interpretation of it, is accurate. To clarify further, you may not rely upon this information as legal advice, nor as a recommendation or endorsement of any particular legal understanding, and you should instead regard this article as intended for entertainment purposes only.

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Originally published Oct 1, 2014 6:00:00 AM, updated July 28 2017

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