Everyone knows that media — TV, internet, radio, etc. — is filled with commercials. And television may be the worst. The number of commercials shown during an average hour of television has risen at a phenomenal rate and, according to Nielsen, is now around 14½ minutes per hour.
As we all know too well, many of these commercials are for prescription drugs. A little over two decades ago the Food and Drug Administration (FDA) loosened restrictions on advertising prescription drugs on television. Prior to the rule change, brand-name prescription drugs were only marketed directly to healthcare providers.
Now we see advertisements for drugs and conditions from the common to the rare and we hear about benefits, complex side effects and risks. It can easily be frightening and overwhelming.
A drug is “prescription-only” when a medical professional must supervise its use because patients are not able to use the drug safely on their own. Congress has laid out different requirements for prescription and non-prescription or “over-the-counter” drugs. Congress also gave the FDA authority to oversee prescription drug ads. However, while the FDA oversees ads for prescription drugs, the Federal Trade Commission (FTC) oversees ads for over-the-counter (non-prescription) drugs.
The FDA has a great section on their web site called “Be Smart About Drug Advertising — A Guide for Consumers,” to help. Some basic information from the FDA about advertising can help you with prescription drug commercials.
Prescription drug advertising must:
• Be accurate;
• Balance the risk and benefit information;
• Be consistent with the prescribing information approved by the FDA; and
• Only include information that is supported by strong evidence.
There are a number of different kinds of ads and they each have different requirements. Product claim ads are the only type of ad that can name a drug and discuss its benefits and minuses. According to the FDA, the ad must use understandable language and present the benefits and risks in a balanced way.
All the risk information does not have to be included; if not, the ad must tell viewers/listeners where they can find more information. Reminder ads give the name of the drug, but not the drug’s uses. The reminder ad does not list risks therefore reminder ads are not allowed for certain prescription drugs with serious risks.
The FDA states that drugs with serious risks have a special warning called a “boxed warning.” Because of their seriousness, the risks must be included in all the ads for these drugs.
Help-seeking commercials describe a condition or disease but do not recommend a particular drug. Help-seeking ads may include a drug company’s name along with contact information.
Other kinds of marketing materials such as brochures and direct mailing called “promotional labeling” are also used to advertise prescription drugs. If these materials mention the drug’s benefit(s) they must also mention the drug’s prescribing information.
Some common violations are:
• Omitting or downplaying the risks;
• Overstating the effectiveness; and
• Misleading drug comparisons.
If you think a prescription drug ad violates the law, contact FDA’s Office of Prescription Drug Promotion through the FDA web site.
The FDA also has a “BAD AD” outreach program designed to educate healthcare providers about the role they can play in helping the FDA make sure that prescription drug advertising is truthful.
As the commercials say, talk to your doctor. Your healthcare provider is the best source of information about what medicines are right for you. The prescription drug commercials can give helpful information that we can then use to work with our healthcare provider in making wise treatment decisions.
The Northeast Regional Cancer Institute can provide additional information on the above topic. Feel free to visit the Cancer Institute website at cancernepa.org, or contact the organization by calling 1-800-424-6724.