Marketing and advertising prescription medications to physicians and the general public is big business. Pharmaceutical companies spend much more on these campaigns than they do on actually research, development, and clinical trials for new drugs. The spending for marketing drugs reaches into the billions each year.
There are rules in the U.S., set by the Food and Drug Administration (FDA), for how pharmaceuticals can be advertised. Drug companies don’t always follow the rules and FDA fines and lawsuits have been issued in some cases. As social media sites become more important for marketing, the FDA has set some preliminary guidelines for drug companies, but it is still a gray area.
Advertising drugs at all is a controversial concept, especially the use of direct-to-consumer, or DTC, advertising. Critics say it can be misleading and may cause patients to pressure their doctors to prescribe them drugs that are not appropriate. Proponents say this kind of advertising keeps the public better informed. There are also issues with marketing directly to physicians, including conflicts of interest.
A History of Pharmaceutical Marketing
Anyone living in the U.S. who watches television or reads magazines has experienced prescription drug ads. Sometimes it seems as if we are bombarded with them, but it wasn’t always like this. The amount of spending on advertisements directed at the public, as opposed to physicians, has increased from $166 million to $4.2 billion between 1993 and 2005. During a similar period of time, from 1992 to 2009, the average number of prescriptions each person received in the U.S. went up from seven to 12. Whether this is a good thing or not is up for debate.
The FDA first received regulatory power over medications in 1906. In 1911, a Supreme Court decision led to the requirement that drug makers had to provide the ingredient information to consumers and the following year saw a law that prohibited labeling medications with false claims. It wasn’t until 1967 that it became a requirement that drug companies provide detailed information to consumers. This is why each medication now comes with lengthy inserts about how to use it, the risks, side effects, and other information.
Up until the early 1990s, pharmaceutical companies focused their marketing efforts largely on physicians. There were no regulations for or rules against DTC ads for drugs, but the manufacturers just weren’t focused on consumers. Around the late 1980s or early ‘90s increased DTC advertising until the FDA could no longer ignore it and felt obliged to regulate these kinds of ads. The first rules came out in 1993, but in 1997 the FDA relaxed those rules. From this point on, drug companies were not required to spend an equal amount of time in an ad on promoting the drug and explaining the risks. The risks quickly took a back seat and DTC ads exploded throughout most types of media.
FDA Rules for Pharmaceutical Advertisements
When ads are directed at consumers, the drug companies are supposed to follow certain rules and regulations set by the FDA. To set those rules the FDA outlines three kinds of advertisements:
- Product Claim Advertisement. This is any ad that names the drug in question and talks about the benefits and risks of taking it.
- Reminder Advertisement. This type of ad names the drug, but does not talk about the purpose or use of the drug. The assumption is that the viewer already knows what it is and the ad serves only as a reminder.
- Help-Seeking Advertisement. These ads communicate information about a particular health condition or disease, but do not recommend a specific type of treatment or medication. The purpose of the ad is to encourage the viewer to talk to a doctor about symptoms.
The rules for advertising are most strict for product claim ads. According to the FDA these ads cannot provide any information that is false or be misleading in any way. All product claims have to include the brand and generic names of the drug, one or more uses for the drug, as approved by the FDA, and the risks of taking the drug that are most significant. The listed benefits and risks must be balanced in the ad. On television ads the risks must be spoken, not just given in print on the screen.
Reminder ads do not have to list any of the risks of a medication because they do not make any claims about benefits or uses. Drugs that have risks serious enough to have earned a “black box” warning from the FDA cannot be promoted through reminder ads. Any ad for this kind of drug must include the risks. For help-seeking ads there are no regulations as long as they do not mention a specific drug. They can give the name of a pharmaceutical company, though.
Drug Advertising and Social Media
For social media advertising the FDA has set guidelines, and any actual ads have to follow the DTC guidelines for broadcast and print ads. However, social media can be a complicated gray area for drug advertising. It can be hard for the FDA to enforce its rules in the large virtual world of social media. And then there are drugs that may be promoted that haven’t been approved by the FDA.
One example of how the FDA has tried to enforce regulations occurred on Instagram in 2015. Kim Kardashian posted a photo with a bottle of the anti-nausea prescription Diclegis with a description of how it helped her overcome morning sickness. The FDA contacted the manufacturer, Duchesnay, and informed them that the ad was unbalanced and did not reflect risks in addition to benefits. A corrective post included all the necessary information, but this was just one instance in many that may slip through the cracks.
Social media is so tricky because it doesn’t always look like traditional advertising. Followers of Kardashian may not have realized that she was being paid by Duchesnay to promote the drug. Social media accounts for celebrities in particular may seem like fans are being offered an honest look at their lives, and this allows promotions for everything from drugs to photo printing services to seem as if they are not really advertisements. To some readers it may have seemed like Kardashian was just a friend offering her opinion about a medication that worked for her.
Celebrities with the biggest followings on social media have fans in the millions, and tens of millions. This represents an irresistible market for drug companies to target consumers. As fewer people watch television ads, it only makes sense to turn to social media. Advertising in this way is even more controversial than traditional DTC ads and is likely to continue to be a problem for the FDA.
An example of Big Pharma Breaking the Rules
Several pharmaceutical companies have been fined by the FDA and have had to pay out in settlements into the millions and billions, for breaking the advertising rules. One such mistake cost Pfizer $2.3 billion in a settlement in 2009. An investigation found that people throughout the company, from sales reps to executives, knowingly and intentionally illegally marketed several of its drugs, including Bextra, which was subsequently removed from the market.
They were promoting these drugs for uses that had not been approved by the FDA. Bextra had been approved by the FDA to treat the pain of menstrual cramps and arthritis. It was not approved for acute pain and could not be shown to be more effective than ibuprofen, an over-the-counter painkiller. In spite of this, sales reps were told to market Bextra to physicians as being able to treat acute pain and at doses larger than what had been approved. This put patients at serious risk for kidney, heart, and skin side effects.
The $2.3 billion that Pfizer was forced to pay out was a record amount, more than any other drug company had been fined by the FDA. To put into perspective just how much money these companies make, that sum equaled just three weeks of sales for Pfizer. This example of a violation is similar to others that have been seen in just about every major drug company operating in the U.S.
The Pros and Cons of DTC Advertising of Medications
The intentional flouting of the rules that are designed to protect patients illustrates just one of many ways in which Big Pharma is a controversial industry. DTC ads, whether on social media or not, also continue to be controversial with both supporters and detractors. Those who support such advertising, which of course includes Big Pharma itself, claim that these ads promote better health by informing the public. They say that more information leads patients to be more open with their doctors and that the ads help to reduce the stigma that comes with many illnesses and conditions.
Critics say that advertisements, even when following FDA rules, are too often misleading, that they give a sunnier picture of how drugs can benefit patients while downplaying risks. They claim that ads don’t really give consumers all the information they need, that the strong promotion of prescriptions encourages drug abuse, and that the ads lead to the use of expensive drugs when affordable generics are available.
Marketing to Physicians
While the increase in DTC marketing for drugs has been huge in recent decades, it doesn’t mean that drug companies have slowed down their efforts to push products to prescribing physicians. While selling medicines to doctors makes sense, it is not without controversies. Kickbacks, conflicts of interest, and shady promotional techniques overshadow what should be a doctor choosing medications based on how they can help patients.
Until the trade organization for pharmaceutical companies, PhRMA, published guidelines for interacting with healthcare professionals in 2002, the job of a pharmaceutical sales rep was essentially to wine and dine doctors. Using the vast resources of the company, sales reps would take doctors out to fancy dinners, to sporting events, and even on tropical vacations.
The voluntary guidelines halted those kinds of gifts, and even branded trinkets like pens, but critics say the smooths selling merely shifted. One of the most common ways now to sell to a doctor is to ask him or her to be a paid speaker for the company. It’s just another way to give a doctor a gift in an effort to promote drugs.
Marketing in the pharmaceutical industry will shift and change, but one thing will remain constant: these companies have billions to spend on promoting their drugs. No matter how regulations change, how the government fines companies, or how informed the public is, drug companies will likely continue to use whatever tactics they can to sell their products, whether it is in the best interest of patients or not.