: This FDA initiative monitors drug-related advertisements for violations

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Description: Any ad that gives a false impression about what it advertises qualifies for a bad ad and can be reported to the FDA

“Bad Ads”: You can help the FDA!

What is Bad Ads program?

Bad Ad Program, also called as Truthful Prescription Drug Advertising and Promotion, is an excellent initiative by the Division of Drug Marketing, Advertising, and Communications (DDMAC) to check Bad Ads. DDMAC is a division of Federal Drug Administration (FDA) which monitors drug-related advertisements for violations.

Bad Ads are the advertisements that give out misleading information about prescription drugs.

The aim of Bad Ads program is to encourage healthcare providers to identify or recognize misleading advertisements. This program also offers an easy way to report such activities to DDMAC.

Approved advertising practice

Prescription drug advertisements must be accurate, information provided orally or in written form should be consistent with the information approved by FDA, the advertisement should provide both the risk and benefit information in a balanced manner, and only information supported by evidence from clinical studies can be used.

Bad advertising

An advertisement that omits the risks, overstates the benefits, underplays the risk factors, provides misleading information or misleading drug comparisons or promotes off-label uses is in violation and such an advertisement must be reported to the agency.

Types of advertisements and promotions monitored by DDMAC

  1. presentations by sales representatives
  2. presentation by speakers
  3. Media advertisement like television, radio or internet video.
  4. Any and all printed or written materials used for drug promotion.

Exclusions

Over-the-counter drugs, medical devices and dietary supplements do not come under the DDMAC regulation.

 Future of Bad Ads program

The Bad Ads program is a planned three-phase program, with the first phase being to create awareness about bad ads and encouraging them to report such ads through educational material and collaboration with the health care providers. The second and third phases are planned to be refinements in the program in terms of creating better awareness through different channels and to encourage reporting by incorporating the feedback on the first phase.

What after reporting?

A prescription drug ad once reported, based on the class of drug it belongs to, will be sent to the concerned regulatory review officer at DDMAC.  That officer will look into the ad and determine if the ad is sufficient to enforce action or further evidence is needed. If more information is required, ongoing monitoring and surveillance activities are undertaken to confirm any violations.

I want to help the FDA, How do I report a Bad Ad?

A bad ad can be reported on the toll free number 877-RX-DDMAC or via email to badad@fda.gov.

A bad ad can be reported anonymously as well. However, if the reported provides contact number or contact address, any follow up can be done by the DDMAC of required.

 

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