FDA’s New Rules Aim to Make Pharma Ads Easier to Understand
/By Crystal Lindell
The Food and Drug Administration is hoping that its new rules will make pharmaceutical ads on TV and radio easier to understand.
Commercials for pharmaceutical drugs must now include a “major statement” about side effects and contraindications in “a clear, conspicuous, and neutral manner.” The rule applies to direct-to-consumer (DTC) ads for prescription drugs and what conditions they are used to treat.
The new regulations are a response to something many drug makers figured out long ago: people tend to tune out when they start to hear a long list of potential side effects and interactions, which are usually rushed through at the end of drug commercials. By then, consumers may have tuned out the downsides of the medication.
“If you’re a company and you’re worried about possible FDA enforcement or product liability and other litigation, all your incentives are to say more, not less,” Torrey Cope, a food and drug lawyer, told the AP.
The law firm Lerman Senter broke down the five new standards the FDA requires companies to meet in drug ads. All commercials must now include:
Consumer Friendly Language: Ads must clearly state the name of the drug, and a major statement of side effects must be presented in language that is readily understandable. It should not include technical or medical jargon.
Understandable Audio: Audio information must be understandable in terms of volume, articulation and pacing, and should be as understandable as the rest of the commercial. “Rapid fire” disclosures will no longer be permitted.
Major Statement Must Be Presented Concurrently in Text and Audio: Television ads must present the major statement simultaneously in the audio and visual sections.
Text Must Be Easily Readable: The on-screen text must be presented against a contrasting background for sufficient duration, and in a font size and style that is easily readable.
No Distractions. Advertisements cannot have statements, text, images or sounds that detract from comprehension of the major statement. No other sounds, including music or catchy jingles, should be heard during the side effects disclosure.
While the rule went into effect a few months ago, companies have until November 20 to be in full compliance. So while you may have already noticed pharma ads changing, all of them should be in compliance starting this week.
In its report about the changes, the FDA said that while drug ads often have a caveat urging people to “ask your doctor” about a medication, pharmaceutical companies are incentivized to make the ads deceptive in various ways.
“Like all advertisers, prescription drug firms have ample business incentives to present their products in a positive light to potential consumers,” the FDA said. “But those business incentives do not assure clear communication of the advertised drug’s negative attributes to consumers.”
While no federal law has ever banned pharmaceutical companies from directly advertising to consumers, the practice didn't really take off until about 40 years ago. Currently, the United States and New Zealand are the only two countries that allow DTC drug advertising.
In its report, “Background on Drug Advertising,” the FDA explains:
"Until the mid-1980s, drug companies gave information about prescription drugs only to doctors and pharmacists. When these professionals thought it appropriate, they gave that information to their patients. However, during the 1980s, some drug companies started to give the general public more direct access to this information through DTC ads."
As someone who was born in the mid 1980s, I remember being surprised as an adult when I learned that most other countries ban pharma companies from advertising directly to consumers.
While it’s difficult to imagine that the U.S. would ever ban the ads completely, there’s definitely a good case for heavily regulating them. A 2005 study found pharmaceutical ads that encouraged consumers to talk with their doctors “have a profound effect on physician prescribing” and could promote overuse or inappropriate prescribing.
In other words, drug companies are very good at creating ads that make people want to buy their products, whether they need them or not. Let’s be real: if drug advertising didn’t work, companies would not be spending over $15 billion a year promoting their medications.
I’m glad to see the FDA amping up these regulations, so people have a better understanding of drug ads. But it remains to be seen how these agency regulations will hold up under the incoming Trump administration.
