Online Safety Community

Marketing and promotion of drugs and medical devices

Regulation of the promotional aspects of prescription drugs, biologics, medical devices and biotechnology products with the intention of ensuring that the information contained in the promotion material is not false or misleading is one of the chief objectives of the FDA.

The FDA regulates the promotional materials of all drugs, and this includes both labeling and advertisements. Brochures, booklets, detailing pieces, bulletins, calendars, motion pictures and slides are some of the examples of labeling, while materials published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television and telephone communications systems are examples of advertising.

The FDA also regulates another avenue of drug promotion and advertising, namely detailing. This kind of promotion is the one that pharma companies do to doctors in a variety of venues such as medical offices, hospitals, pharmacies, at medical meetings and symposia, academic settings, conferences and other meeting facilities.

The FDA’s reach in monitoring and regulating promotions also covers direct-to-consumer (DTC) prescription drug advertising. In this area, it has complete jurisdiction over prescription drug labeling and advertising and all medical device labeling, but has limited jurisdiction over medical device advertising.

Severe penalties for offenders

For decades, the FDA has been regulating traditional advertising, during the course of which it has been publishing several kinds of guidance documents for industry, and has issued many violation letters. The corrective actions that companies have to implement if the FDA adjudges that drug or medical device promotional material is false or misleading or does not give a proper account of the product needed to enable consumers to weigh the benefits and risks are very expensive and time consuming. They have to carry out expensive remedial advertising, have to cough up huge fines, and also face the prospect of having their reputation sullied on account of these enforcement actions from the FDA.

In addition, it can also criminally prosecute relevant executives of such organizations under the provisions of a strict liability standard. This law gives the government sweeping powers, by which it is not obliged or required to show that the executive facing prosecution had the intention of violating FDA regulations or was knowledgeable about such violations.

The agency has already netted billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or "off-label," uses.

Are the FDA’s laws obsolete?

Yet, the general consensus is that the law governing drug and device marketing is both outmoded and insufficient to deal with the speed at which technology-enabled promotion campaigns appear out of nowhere and disappear in a jiffy. Experts feel that the FDA is still very conservative and traditional in adapting technologies needed for detecting and nailing down such promotion campaigns that technology has brought about. Naturally, the regulatory circles are eager to see how the FDA will deal with the advanced communication technology that goes into promotion campaigns that can make the advertisement go viral and leave the scene just as quickly.

These are important aspects for organizations in the drugs, biologics, medical devices and biotechnology areas. These companies need to be completely aware of the law governing advertising and need to understand the FDA’s thinking on what it considers false and misleading advertising. This knowledge is absolutely essential, considering the broad sweep of powers that the FDA has.

Important learning on the FDA’s approach to promotions and advertising

This important understanding will be imparted at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. At this seminar, David R. Dills, Global Regulatory Affairs and Compliance Consultant, who provides regulatory affairs and compliance consultative services, will be the Director. To gain insights into the FDA’s thinking on how it perceives advertisements and promotions as false and misleading, please register for this seminar by visiting Marketing and promotion of drugs and medical devices. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Advertising aimed at healthcare professionals and consumers

Prescription drug promotion is aimed at and delivered to two distinct audiences: Health care professionals (HCPs) and consumers. The FDA recognizes that promotional efforts can provide these audiences important information about the newest developments in drug therapies. So, it insists that such information has to have integrity and completeness.

Also, healthcare professionals, sales representatives and consumers use the social media to discuss the use of prescription products for specific diseases and conditions, a factor that has to be taken into account. David will discuss this and the potential concerns it carries.

Views: 99

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

swethakumar posted a blog post

Enroll yourself for NEBOSH course in Mumbai to become as a Safety Expert

NEBOSH IGC is one of the topmost health and safety qualifications for all sorts of workers in health and safety sector. Nebosh Course in Mumbai gives knowledge of safety in addition to practical training in the management of Health and safety issues. Read More…See More
yesterday
Mark Nilson posted events
Friday
John Robinson posted a blog post

eCTD Submissions of IND-NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The…See More
Friday
Training Doyens posted an event
Thumbnail

Live Webinar on How to Hire, Retain, and Grow a Diverse & Inclusive Workforce at 26468 E Walker Dr, Aurora, Colorado 80016

February 19, 2019 from 1pm to 2pm
OVERVIEWSTOP - Do not put out another hiring notice until you fully consider the ramifications of diversity and inclusion in the workplace.  Why is this important? First, if you have diverse customers, those customers will relate to the diverse employees helping them or selling to them. Second, to avoid a homogeneous culture where people want to fit in so desperately that…See More
Friday

Forum

Important of Warning sign 1 Reply

Warning sign is a type of traffic sign that guide a hazard ahead on the road. Having proper warning sign on the road provide a healthy environment.Continue

Tags: Signs, Workplace, Safety, Sign, Warning

Started by healthandsafetysigns. Last reply by Jen McDade Jan 14.

Workers paticipation in safety management 2 Replies

Workers paticipation in safety management is the aspect which is required to be implemented in the OHSAS 18001 2007 version. , I invite our experience community members to share their views on the…Continue

Tags: management, safety, in, paticipation, Workers

Started by SafetyRaja. Last reply by Tara safe Dec 27, 2018.

How to improve safety culture of factories 4 Replies

How to improve safety culture of factories having mostly contract and casual ever changing workers for whom training and monitoring both are major issues. Such qorkers are mainly meeting accidents in…Continue

Started by Harkant Dave. Last reply by Jen McDade Dec 24, 2018.

[General Industry] What is your workplace's policy on headphones? Working on one currently. 1 Reply

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their…Continue

Tags: general, industry, distraction, music, phone

Started by Kyle C. Johnson. Last reply by Jen McDade Dec 19, 2018.

Biggest Challenge? 5 Replies

As a distributor of safety supplies, as a webmaster who is trying to sell safety supplies online, one of my main goals is to try to provide value above and beyond just selling supplies and product.So…Continue

Started by Safetyguy08. Last reply by Jen McDade Dec 18, 2018.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service