Pfizer had a killer direct-to-consumer ad for its anti-cholesterol drug Lipitor in 2006-2008. Robert Jarvik, identified as the inventor of the artificial heart, turns to the camera and says, “Just because I’m a doctor doesn’t mean I don’t worry about my cholesterol.” After recommending that people use Lipitor, the commercial shows him rowing across a lake. While the ad cost Pfizer $260 million, it played fast and loose with several facts. Robert Jarvik had never been licensed as a medical doctor so he could not legally prescribe anything. He didn’t actually invent the artificial heart; and he didn’t even row the boat in the commercial. “Welcome to the world of direct-to-consumer advertising.”

Television direct-to-consumer (DTC) ads have become the most ubiquitous means of Pharma advertising. It is estimated that a person in the U.S. watching an average of 4.3 hours of broadcast television per day will see nine drugs ads, totaling around 30 hours of direct-to-consumer (DTC) ads each year. In 2017, spending on DTC ads in the U.S. reached $6.1 billion; a 4.6% decrease from 2016 ($6.4 billion).

The FDA has oversight of DTC ads by the pharmaceutical industry through the Food, Drug and Cosmetic Act of 1938. Congress approved the Act in an effort to protect the health and safety of U.S. citizens by regulating the food and medical supply. “The Act regulates the pharmaceutical industry to ensure the safety and efficacy of drug produced and sold in the United States, and it gives the FDA authority to carry out its legislative directives.” Amendments in 1962 by Congress to the Food, Drug and Cosmetic Act transferred the regulatory authority of prescription drug advertising from the Federal Trade Commission to the FDA. “With the addition of the 1962 amendments, the regulation of drugs became the most consuming, and at times the most controversial, aspect of all the FDA’s activities.”

As a result of these actions, drug companies are required to submit all their promotional materials to the FDA’s Office of Prescription Drug Promotion (OPDP). However, limitations on the capacity and resources of the OPDP mean it cannot review every single ad. Nevertheless, there was not a significant amount of DTC advertising even after the FDA made it possible in 1985.

The Food, Drug and Cosmetic Act has been traditionally understood by the FDA to restrict unapproved or “off-label” promotion use. FDA regulations explicitly prohibit DTC ads from even suggesting any off-label use. While print ads must state all of the risks in the drug’s FDA-approved label in a “brief summary,” broadcast DTC ads are only required to include the major risks, as long as those risks are verbally communicated and the ad provides a source for consumers to access the FDA-approved labeling for the drug.

In 1997, the Division of Drug Marketing, Advertising, and Communications (DDMAC), a sub-division of the Center for Drug Evaluation and Research (CDER), which is a division of the FDA, released guidelines which allow prescription drug manufacturers to comfortably satisfy the legal requirements for advertising their products to the general public. As a result, pharmaceutical companies have swelled their direct-to-consumer (DTC) marketing budgets and provided the advertising industry with a profitable new line of products to promote. Since the regulatory change was announced, name-brand prescription drug use in the United States has increased, drug prices have gone up, a debate over the effects, efficacy and wisdom of DTC ads has ensued, and scores of heath care issues that affect patients, doctors, insurers, and the federal government have risen to the surface.Despite the wide enforcement authority generally given to the FDA, the Act expressly prohibits any requirement that pharmaceutical companies submit drug advertising content for FDA pre-market approval (except in extraordinary circumstances). This provision, grounded in First Amendment doctrine, has led to a regulatory regime that can only offer a pre-market approval process and enforce compliance post-violation.

This protection of the pharmaceutical company’s right to speak has occasionally resulted in ads giving information that did not satisfy the Act’s requirement that all advertisements give a “fair balance” of the drug’s benefits and risks. Drug companies have also used this provision to challenge certain FDA restrictions on off-label marketing.”Recent federal court cases have permitted companies to promote off-label indications, thereby calling into question the FDA’s authority to regulate off-label marketing, even with respect to DTC advertising.”

“Adherence to FDA Guidelines in DTC Advertising” by Klara et al. noted where previous studies have found many Pharma companies do not follow the advertisement guidelines set forth by the FDA. They assessed the degree to which recently aired DTC ads (between January 2015 and July 2016) for prescription drugs adhered to FDA regulations and whether off-label use was suggested. They looked at both prescription and over-the-counter medications. Among the 67 ads with unique drug-indication combinations, the most commonly advertised conditions are noted in the following table.

More than ¾ of the ads were to treat chronic conditions; 18% were for intermediate conditions; and 6% were for acute conditions. Sixty percent referred to potential savings on or payment for the drug. And forty percent advertised drugs with black box warnings.

The median time spent describing drug risks was 45% of the ads, while the median time for other forms of communication, such as a description of the benefits or drug indication was 55%.  The median number of risks mentioned was 16. Forty-two percent of ads used a different announcer for risk and benefit information. When all of the ads presented their risk information, there were distracting visuals like frequent scene changes or characters dancing or singing. Seventy-nine percent had running text on screen that was unrelated to the risks, like “See our ad in Weight Watchers.”

Our findings demonstrate that the quality of information in DTC television ads is low: none described drug risks quantitatively; only one-quarter described drug benefits quantitatively; and suggestions of off-label promotion were common for diabetes medications. Though proponents argue that DTC advertising is educational and empowering for consumers, our findings suggest that the information provided is unreliable and potentially misleading. The promotion of off-label indications, poor quality of information, distracting risk presentations, and the fact that risks are never quantified could distort the perception of benefit and risk information.Suggestions of off-label use, a practice that has been expressly prohibited in prescription drug DTC advertising, occurred in 13% of ads in our sample. All of these ads marketed drugs indicated for the treatment of type2 diabetes, and suggested potential benefits of use, including weight loss and blood pressure reduction.

Data were rarely provided to support the drug benefit claims, and the risks were never quantified. “Broadcast DTC advertising could lead patients to make healthcare decisions and request certain expensive, brand-name medications based on ads containing low-quality and incomplete information.” The researchers noted a suggestion that the FDA should review television commercials for prescription drugs before their release to ensure these ads are more informative for the public. They also suggested further study of the impact of off-label marketing by DTC ads on patient and prescriber decisions. “By enacting such a program and by enforcing more objective requirements for DTC advertisements, the FDA could better protect consumers.” Commenting on the above study for Mad in America, Shannon Peters said:

Patients deserve quality, comprehensive information about drug benefits and risks in order to provide informed consent and be truly empowered in their healthcare decisions. In their current form, most DTC advertisements are misleading rather than promoting informed consent.

The website Medical Marketing & Media provided data on DTC ad spending by pharmaceutical companies in 2017.  There has been an overall increase of $2.6 billion yearly from 2012 to 2016. Broadcast TV spending for DTC in 2016 was $4.06 billion, with magazine spending ranking second with $1.7 billion. The top ten companies by U.S. DTC spending were: Pfizer ($1.2 billion); Bristol-Myers Squibb ($458.2 million); AbbVie ($433.3 million); Eli Lilly ($414.7 million); Allergen ($352.3 million); Johnson & Johnson ($292 million); Merck ($285.2 million); Novartis ($254.8 million); AstraZeneca ($226 million); and Novo Nordisk ($206.7 million).

Pfizer eventually cancelled its Lipitor ad campaign with Robert Jarvik after there was a Congressional outcry over false impressions in the ad. But the marketing misstep didn’t stop Lipitor or Pfizer. Lipitor became the world’s best-selling drug with more than $125 billion in sales over 14.5 years. Pfizer also didn’t lose faith in DTC, as it was number one in DTC spending in 2015 and 2016. But I bet they’ve been shrewder in how they marketed their drugs. You can watch the Jarvik Lipitor ad here.