HW06_Study group 01

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Northeastern University *

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Apr 3, 2024

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1 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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