It has been almost two decades since pharmaceutical manufacturers decided that they might have better luck promoting their products if they bypassed doctors and took their messages straight to consumers. And although the Food and Drug Administration is keeping a wary eye on direct-to-consumer advertising, the practice now appears solidly entrenched. The United States and New Zealand are the only two countries among developed nations that permit direct-to-consumer advertising.
Direct-to-consumer pharmaceutical advertising, or DTC, was never against the law. But pharmaceutical manufacturers began targeting consumers in the 1980s and, in 1999, the FDA clarified the rules on DTC advertising to better protect consumers. Since then, the practice has exploded. According to a 2011 report issued by the Congressional Budget Office, DTC advertising totaled $4.7 billion in 2008—about one-quarter of pharmaceutical manufacturers' promotional budgets.
This year, the FDA launched two new studies on the impact of DTC drug ads and also issued new instructions to manufacturers on how it will review the content of drug ads. However, other attempts to reign in DTC ads, such as through legislation, haven't progressed very far.
"I think there are a lot of people who want us to pull back from DTC advertising. They think it's gotten out of hand," Francis B. Palumbo, professor and executive director of the University of Maryland School of Pharmacy Center on Drugs & Public Policy, told TakePart. But, he adds: "It's kind of woven into the fabric of American culture now. To pull it back would be very difficult. It's a question of what would happen if you pulled the plug."
Some studies suggest that DTC ads aren't so bad. The ads can educate people, help them start a conversation with their doctors, and even prompt someone to see a doctor when they otherwise might not have. Information contained in the ads may improve patient compliance regarding instructions on how to take a particular drug and how to spot side effects.
But the ads have generated considerable controversy. Doctor groups tend to dislike the practice, Palumbo says, because consumers demand prescriptions for certain medications they've heard about on TV. Sometimes, doctors say, their patients would benefit more and save money by taking a different medication than the one advertised on television.
"Patients put more pressure on their doctors to prescribe a particular drug when they see it on TV," Palumbo says.
Other healthcare experts have questioned whether DTC leads to higher drug costs. And, because many DTC ads are for newly approved medications, some critics say the ads expose consumers to unnecessary risks. For example, the drug Vioxx was heavily advertised and sold to millions of people but was later taken off the market because of serious health risks linked to its use.
Certain classes of medications advertised to consumers have triggered considerable controversy, such as advertisements for drugs to treat depression, Palumbo says. While it may be helpful for consumers to know there are treatments for depression, drug companies have been criticized for pitching atypical antipsychotics, a newer class of drugs, for the treatment of depression. Many atypical antipsychotics are costly and carry harsh side effects. Typically, such medications are only prescribed when other treatment options have been exhausted.
According to the Congressional Budget Office report, pharmaceutical manufacturers only promote a small set of specific drugs using DTC. The CBO looked at 366 brand-name drugs that were promoted to doctors and other healthcare professionals from 1999 to 2008. Of those drugs, only 73 were advertised directly to consumers. Drug companies spent an average of $71 million per drug for a two-year period of DTC advertising.
The CBO found that the average number of prescriptions for newly approved brand-name drugs with DTC advertising was nine times greater than the average number of prescriptions written for newly approved brand-name drugs that weren't advertised. But pharmaceutical companies are selective about which products are advertised to consumers. They tend to focus on medications for common conditions that affect large numbers of people, like high cholesterol or seasonal allergies.
"When pharmaceutical companies advertise directly to the consumer their sales go up," Palumbo says. "That's why they do it. They garner huge sales."
The FDA is watching the DTC scene carefully. Earlier this year, the agency launched a study examining the impact of "corrective" direct-to-consumer advertising. This is a type of ad that the agency demands of pharmaceutical manufacturers when the company's initial ad features false or misleading information. One of the best-known examples of a corrective ad was for the birth control pill Yaz. The agency is looking at how corrective ads impact consumer misperceptions about the drug. In other words, do the corrective ads reverse the false impression?
Another FDA study, announced in August, will examine whether consumers understand ads for drugs that have "composite scores." These are drugs that are advertised for multiple symptoms, such as an allergy drug touted for sneezing, runny nose, watery eyes and wheezing. Such drugs are given a single composite score (encompassing the effectiveness scores for each particular symptom) that shows how effective the drug is compared to another drug. But, the FDA states: "Because most DTC prescription drug ads do not explicitly state that they used composite scores" consumers may not understand the drug's actual efficacy.
Also this year, the FDA informed pharmaceutical companies that it wants to review DTC ads for new drugs and drugs with new indication before they appear before the public to make sure the ads include all pertinent risk information. The agency will have 45 days to conduct the review
"FDA is under a lot of criticism for that," Palumbo notes. "FDA is always under-resourced, and the question is whether FDA will get back to the manufacturer in a timely manner. The manufacturers are spending millions of dollars putting out these ads. They want to run them."
Question: Should FDA tighten the reins on DTC drug ads? Tell us what you think in the comments.
Shari Roan is an award-winning health writer based in Southern California. She is the author of three books on health and science subjects.