Rules and Regulations

Advertisements for Perscription Drugs

The "Must Have's" For Advertisements

  • 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

In Depth Rules on Advertisements

  • These are a number of ways in which an ad may violate the law. For example, the ad could:
    • State or imply that the drug can treat a condition when the FDA has not approved the drug for such use
    • Make claims that are not supported by adequate evidence
    • Misrepresent data from studies
    • Overstate the drug's benefits
    • Suggest that the drug can be used in patients with specific characteristics when the drug hasn't been shown to work or to be safe in such patients
    • Leave out or downplay risk information
      • Fail to present a fair balance of information relating to the drug's risks and benefits
      • Leave out a brief summary
      • Fail to attach the drug's prescribing information
      • Fail to include sources to help the audience find the prescribing information for the drug (for product claim ads on TV, radio, or by telephone)
      • Fail to include the required information about where negative side effects can be reported
    • Appear to be a reminder ad but make a claim about the drug
    • Appear to be a reminder ad but is about a drug that has certain very serious risks. Reminder ads are not allowed for such drugs
    • Appear to be a help-seeking or disease awareness ad but recommend or suggest a particular prescription drug
  • The FDA does not review or approve prescription drug advertisments before they are released. Federal law does not allow the FDA to force companies to submit their ads before using them. Even so, some comapnies have the FDA review their ad before releasing it to the public. But the FDA does have the responsibility to report current ads that break the rules.

    The Non-requirements For Advertisements

    • Cost
    • If there is a generic version of the drug
    • 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
      • 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
    • 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

    These rules and regulations are effecvtive in protecting the public's health in some ways. The rules can ensure that all people have a full understanding of the product. People will not be fooled or scammed by the ad. It is very benefitial to know the side effects, and how to know if you can take the drug without having any additional health issues.