FDA Rules For Advertising

Rules and Regulations for Advertising Perscription Drugs

What Must Product Claim Ads Tell You?

  • At least one approved use for the drug
  • The generic name of the drug
  • All the risks of using the drug
  • Under certain circumstances, ads can give only the most important risks

Prescribing Information

The prescribing information includes such details about the drug as:

  • Its chemical description
  • How it works
  • How it interacts with other drugs, supplements, foods, and beverages
  • What condition(s) or disease(s) it treats
  • Who should not use the drug
  • Serious side effects, even if they occur rarely
  • Commonly occurring side effects, even if they are not serious
  • Effects on specific groups of patients, such as children, pregnant women, or older adults and how to use it in these populations

What Are Ads Not Required To Tell You?

  • Cost
  • If there is a generic version of the drug (a drug with the same active ingredient that might be cheaper)
  • If there is a similar drug with fewer or different risks that can treat the condition
  • If changes in your behavior could help your condition (such as diet and exercise)
    • Sometimes this information is required. It depends on the prescribing information for the particular drug
  • How many people have the condition the drug treats
  • How the drug works (its "mechanism of action")
  • How quickly the drug works
    • However, if the ad claims that the drug works quickly, the ad must explain what "quickly" means
  • How many people who take the drug will be helped by it

What Does FDA Do If It Determines That An Ad Violates The Law?

  • We have different ways to enforce the laws that apply to advertisements for prescription drugs. The simplest and most common way is to send a letter to the drug company. The letter explains how the ad has violated the law. It generally asks the drug company to remove the ad and stop the unlawful behavior.
  • In some cases, we will ask the drug company to fix the misimpression made by the violative ad. The fix could include publishing a corrective ad. We are most likely to take this action when the misimpression poses a serious threat to public health.
  • We post the enforcement letters issued by OPDP on the Warning Letters web page.
  • Sometimes we take additional enforcement action. This may include taking drug companies to court and even taking ("seizing") supplies of the drug. Court actions can include asking for an injunction (court-enforced ban of specific activities) and bringing criminal charges against the drug company.