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Homework-06 DIRECT-TO-CONSUMER ADVERTISING
STUDY GROUP 1
(Shivani Goswami, Naishi Kachhadiya, Avnish Patel, Drashti Bhupeshbhai Patel, Siddharth
Tarunkumar Patel, Divya Vennu, Gayathri Vuchooru, Komal Diyora)
Northeastern University
College of Professional Studies (CPS)
2
Homework-06 Introduction
The consumer directed broadcast advertisement are overseen by Office of Prescription
Drug Promotion (OPDP) which is also known as DDMAC (Division of Drug Marketing,
Advertising and Communication) of FDA which works under CDER. (Pisano, 2014) The
prescription product advertisement has several requirements from FDA to fulfill in order to be
eligible for advertising.
(FDA, Guidance for Industry Consumer-Directed Broadcast
Advertisements, 1999) The OPDP’s mission is to protect health by ensuring advertisements are
true, justifiable, accurate. (USFDA, 2022)
Regulations for Advertisements
Title 21 of the CFR Section 502(n), Part 202 outlines specifically the requirements for
advertising prescription drug. It enlists the way information should be presented, how drug’s
safety and efficacy should be communicated. The Form 2253 is required to be submitted to FDA
that is Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use which
FDA OPDP evaluates based on individual submission. (Pisano, 2014) The 21 U.S.C. 352(n) of
FDCA requirements states that information should be in short summary including side effects,
effectivity, and any kind of contraindication. (FDA, Guidance for Industry Consumer-Directed
Broadcast Advertisements, 1999) The 21 CFR 202.1 is referred to understand the different
requirements for broadcasting than that of the printing. Types of Advertisements
1.
Product Claim Advertisements: It is the only type where the promotion is made with its
name and benefits and risks which must be proved based on clinical studies and not at all
deceiving.
3
Homework-06 2.
Reminder Advertisement: In this type only, the name is used without uses assuming
that the viewer already knows. It is not allowed for certain drugs posing serious risks for
which our drug is suitable example since it is having black box warning. 3.
Help-Seeking Advertisements: In this kind of advertisement, it shows or explains the
condition, kind of disease with symptoms.
4.
Other Product Claim Promotional Materials
: It is the label materials given by the
company to people. (FDA, Basics of Drug Ads, 2015)
Broadcasting Considerations and Requirements
Preclearance requirements: Our product will be assessed to see whether it requires
preclearance since some medications treating life-threatening situation are given accelerated
review for which document submission is required 30 days before dissemination. (Pisano, 2014) Fair-Balance requirement: The Section 202.1(e)(5)(iii) of the 21 CFR describes the
requirement of fair balance where it states the drug advertisement must have in fair balance
between the drug benefits or advantages and the side effects or the contraindications. For our
drug, the advertisement must have enough exposure to the black box warning since it is given
when the drug has high possibility of side effects in patient population as well as with the
specifications about yet to be done evaluation of the pediatric patients. (Pisano, 2014)
For our drug, along with the advertisement; the most significant benefit and risk will be
presented with the less associated benefits and risks in the brief. (U.S.F&D, 2019) The drug
advertisement also must include that any negative side effects should be reported to FDA via
MedWatch or on the given number. (FDA, Basics of Drug Ads, 2015)
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to better
that are
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influence the being used for influence the and execution
the intention of
to better
consumer
a longer period
consumer
to be used
of time
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Appeal
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Creative Brief
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theme
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Recommended textbooks for you
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