FDA regulations for pharmaceutical ads.

Chantix. Cialis. Humira. Lyrica.

If you’ve ever sat through a commercial break, chances are you recognize the names of these drugs, as they’re among the top most-advertised prescription drug brands.

Day in and day out, we at Praxis are entrenched in the regulations from the Food and Drug Administration (FDA) governing the pharmaceutical industry and patient recruitment advertising for drugs that have yet to be approved. As a little change of pace, today we wanted to explore the FDA regulations governing the messaging in pharmaceutical ads once a drug has received that FDA stamp of approval.

In 1938, the US passed the Federal Food, Drug, and Cosmetic Act, giving authority to the FDA to oversee safety in three nominal categories. In an effort to ensure patients are not served misleading information when it comes to their health from drug ads, the FDA enforces a strict set of regulations that dictate what pharmaceutical ads in the United States can and cannot include.

These guidelines are fairly extensive, so we’ve created a high-level overview of a few regulations that govern the product claim ad category of pharmaceutical TV advertisements to help educate consumers.

• Prescription drug advertising from pharmaceutical companies must identify both the brand name and the generic name of the drug being advertised. That means an Advil ad, for example, must include the generic name “ibuprofen” in addition to the “Advil” brand name.
• Ads must state an FDA-approved use for the drug being advertised, and they can only make claims supported by “substantial evidence or substantial clinical experience.” This means advertisers should err on the side of caution when making claims that may need more context. So perhaps be more general and say “can help reduce pain” instead of “is the preferred pain reliever for five out of six individuals.”
• Ads must say that the drug is available by prescription only – only a “prescribing healthcare professional” can determine whether someone should take the drug being advertised. To the same point, pharmaceutical ads must direct viewers to seek a doctor’s advice about taking the drug.
• Ads must provide a fair balance of information about the risks and benefits of taking the advertised drug. The risks and benefits of the drug’s list of side effects are intended to capture the viewer’s attention, rather than one overshadowing the other.
• Ads must feature individuals/actors in the approved age range for users of the drug. If the treatment is intended for an older demographic, for example, that should be the primary demographic represented in the advertisement.
• Ads must include what is called “adequate provision.” This means that a number of resources must be provided that will lead viewers to the drug’s prescribing information. Ways of achieving this include providing a 1-800 number to call, or running a print ad in a designated magazine and then referencing the magazine in the broadcast ad.
• Ads must include what is called the “major statement.” This entails disclosing the product’s major risks or negative side effects in either audio alone or audio and visual ad elements – all in an easy-to-understand, patient-friendly format.

Sound like a lot? It is. And that’s just scratching the surface of consumer advertising from drug companies.

FDA regulations can be stringent and overwhelming. If you’re looking for help navigating them in the context of your next pharmaceutical recruitment campaign, learn more about what our focused patient recruitment agency for clinical trials can do for you.