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
anonymously as well. However, if the reported provides contact number or
contact address, any follow up can be done by the DDMAC of requiredGlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
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