FDA Requirements for Prescription Drug Ads

Prescription drugs may be advertised in three types of ads:

1. Product claim ads require the most information and give both the drug name and a medical condition the drug treats;

2. Help-seeking ads may only describe a medical condition or disease but may not name a drug;

3. Reminder ads may name a drug but no medical conditions or diseases.

The FDA sets regulations for prescription drug ads, but it does not review ads before they are released to the public. If an ad violates the regulations, the FDA takes action to have the pharmaceutical company correct or remove the ad.

Below are the requirements for each type of ad from the FDA’s June 6, 2013 “Be Smart about Prescription Drug Advertising: A Guide for Consumers,” available at fda.gov.

1.	Requirements for Product Claim Ads
	1. The drug’s brand name and any generic names for the drug
	2. An FDA-approved use for the drug
	3. A statement that the drug is prescription-only
	4. A “fair balance” of information about the benefits and risks of the drug
	5. An accurate portrayal of the approved age range for the drug (for example, if the drug is for adult men, an adult male should be pictured)
	6. The following statement: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.”
	7. A “brief summary” (one or more pages) in print ads of all of the risks listed in the FDA-approved prescribing information; the brief summary “generally includes: Who should not take the drug; When the drug should not be taken; Possible serious side effects of the drug and, if known, what can be done to lower the chance of having them; [and] Frequently occurring, but not necessarily serious, side effects”
	8. A statement directing the reader to seek a doctor’s advice about taking the drug
	9. Sources of more information (for example, a healthcare provider, toll-free phone number, a current issue of a magazine containing a print ad, or a website address)
	10. False or misleading claims about the drug
	11. Drug uses that are not approved by the FDA
	12. Claims that are “not supported by substantial evidence or substantial clinical experience”

2.	Requirements for Help-Seeking Ads
	1. A medical condition (such as, seasonal allergies)
	2. Symptoms of the medical condition
	3. A recommendation to seek a doctor’s help for the medical condition
	4. A pharmaceutical company name
	5. A prescription drug name or an image of a specific drug

3.	Requirements for Reminder Ads
	1. The drug’s brand name
	2. Any generic names for the drug
	3. Any use for the drug

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