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The FDA has strict requirements on the way promotion and advertising practices are to be implemented by the industries that it regulates. Section 906 of the Food and Drug Administration Amendments Act (FDAAA), which came into effect in 2008 and amended the section that pertained to this topic previously, namely Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA); now requires that published Direct to Consumer (DTC) advertisements for prescription drugs should include the following statement printed conspicuously for all products including vaccines:
“You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.”
One of many requirements
This is just one of the many requirements from the FDA about promotion and advertising practices. Any individual or company holding an approved application for a drug will be panelized for making a false or misleading claim in a Direct to Consumer (DTC) advertisement about the pharmaceutical product.
Such an entity can be fined up to a quarter of a million dollars for the first such violation in any three-year period. This fine can go up to half a million dollars for each subsequent violation in any three-year period. Further, the FDAAA fixes different levels of penalties for biological products.
New requirements that reinforce existing ones
In addition, the FDA issued two Draft Guidance documents in January 2017. These concern communications made by device manufacturers about information that is contained in the labeling of these products. The nub of these Guidance Documents is that for FDA-regulated medical device companies to escape enforcement actions from the regulatory agency; labeling has to be consistent with the standards and expectations set out by the FDA. It lists out a number of factors the FDA takes into consideration to determine if the labeling meets the standards of consistency set out by it. These are some of them:
o Patient Population
o Limitations and Directions for Handling, Preparing, and/or Using the product
o The recommended dosage or use regimen or route of administration
o The potential for increasing harm
o Safe and effective use.
The FDA has, in this communication also set out the factors that it does not consider as being in line with its idea of consistency in labeling and false claims:
o Stage, severity, or manifestation of disease
o Use alone versus in combination with other product(s)
o Route of administration
o Strength, dosage, or use regimen
o Dosage form.
This makes the grasp and proper implementation of the FDAAA requirements absolutely essential if an organization in the FDA-regulated industries has to be free of enforcement actions from the FDA and subsequent penalties.
Learning session on how to get the dynamics of FDA scrutiny of promotion and advertising practices right
This is the important learning a webinar from Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance, will be offering.
The speaker at this webinar is Casper Uldriks, who through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He brings the experience of having specialized in the FDA’s medical device program as a field investigator, a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. To gain understanding and clarity on these areas of FDA scrutiny of promotion and advertising practices, enroll for this webinar by logging on to FDA Scrutinize Promotion and Advertising Practices
Anticipate the FDA’s viewpoint of consistency
Anticipating the way the FDA will view and interpret its advertising and the way it monitors this activity is critical for any company that makes a marketing launch. If it fails to do this right, it could land itself in trouble and invite expensive and reputation-damaging enforcement actions. Companies that come under FDA regulation need to have a perfect grasp of what they are doing with DTC advertising and should not leave anything to chance.
Companies have to keep up with the defined boundaries of DTC advertising and promotion if they have to avoid FDA scrutiny. If the FDA deems a DTC marketing campaign to be misbranding the product, it will not allow it to be marketed. This calls for more sophistication and novelty on the part of firms in their advertising methods and messages. Firms need to pay attention to all the components of their advertising in mass media, such as volume, images, the prominence and conspicuousness of information, the speed of the message, subliminal messaging and the core message.
Get all the factors right to avoid FDA enforcement
This calls for a proper understanding of what each component of the advertising attempts to accomplish and then evaluate the integrated message. Ironically, this range of factors arms the FDA with sufficient ammunition to determine the advertising as misbranding and term it illegal. The speaker will suggest the ways of tackling issues like this.
Casper will talk about these issues in depth at this webinar. He will cover the following areas:
o FDA's approach to DTC advertising and promotion principles
o FDA guidance and use of cognitive psychology
o Types of violation for illegal DTC advertising practices
o The role of sales and marketing departments
o Executives’ legal liability.