FDA compliant labels

Do your medical product claims TRULY match the products’ performance?

Posted on February 18, 2014 · Posted in Labeling and Marketing

We all want to use safe and effective medical devices, drugs and cosmetics.

How do you properly market your products to assure that necessary medical claims are telling the “whole story” and matching the products’ true performance? Specifically, how well are you educating your consumers about benefits and risks?

As you would guess, the FDA plays a large role in determining how you can market your device.

Let’s look at a few guidelines that will help you to keep your customers safe while preventing those unwanted FDA warning letters.

Is your marketing material following these FDA guidelines?

1. Use of consistent language:
The language used to communicate benefits and the language used to communicate risks should be understandable to the same audience for the marketing piece to be considered accurate and non-misleading. Promotional materials directed to professionals can describe benefits and risks in medical language, but promotional materials directed to consumers should convey benefits and risks in language understandable to consumers.

FDA suggested example:
A consumer directed ad for a drug that presents benefit claims in a consumer friendly language should mention a risk of “fainting”, not “syncope.”

This is especially important to keep in mind when your devices are sold to both health care profssionals and over the counter. Package labeling will be different.

2. Use of signals:
Headlines and subheads are examples of commonly used signals. Depending on the situation, accurate claim information in your marketing text may not fix a false headline because consumers may only glance at the headline and skip the remainder of the text. Signals are also used in broadcast situations, such as when an announcer draws attention to different items of information. Or, when a word on the screen identifies a new topic, or when headlines emphasize some messages but not others.

When reviewing promotional materials, the FDA looks to see if the use of signals is consistent across benefit and risk information, ensuring that materials provide accurate and non-misleading impressions of a drug or device.
Is the product doing what is should be doing?

*information obtained from FDA guidance documentation.
Placing risk information under headlines such as “Now Approved for Epilepsy” or “Safe Enough for Children Under 5” minimizes the risk information that follows, particularly if individuals only look at the headlines. Instead, headlines listed before risk presentations should signal that a risk presentation follows, for example, “Important Risk Information about the Effects of Device X .”

3. Framing of risk information:
The FDA evaluates how risk information is framed because framing can impact the presentation of risks and benefits in a marketing piece. Framing commonly refers to how a particular piece of information is stated or conveyed, such as by emphasizing either the positive or negative aspects of the information or by presenting the information in vague versus specific terms. Research consistently shows that framing the same information written in different ways can change the way the audience responds to that information. Thus, the way that information is phrased can influence the message received by the audience.

FDA suggested example:
If a drug’s package insert contains a boxed warning about the risk of life-threatening fevers associated with its use and reports that 55 percent of patients taking the drug experience dizziness, a statement such as “Adverse events associated with drug X include fevers. Some patients experienced dizziness”. This misleadingly describes the risk profile of the drug by failing to convey the seriousness of the fevers and the frequency of the dizziness.
Statements like “Life-threatening fevers have been reported with the use of Drug X” and “More than half of patients taking Drug X experienced dizziness” would convey the seriousness and frequency of the two risks appropriately.

4. Hierarchy of risk information:  
The FDA considers the ordering of risks within a marketing piece an important factor in determining the risk profile displayed by that marketing piece; regardless of whether it is directed toward healthcare professionals or consumers. For example, if risks are placed too far into the text of a marketing piece, readers may lose interest toward the end of a lengthy paragraph, and may not read or comprehend the later information accurately. Risks and benefits must be discussed in the same paragraph with balanced information.

FDA suggested example:
A statement in a broadcast ad that states “Patients should not drink alcohol when taking Drug X, as common side effects are drowsiness and nausea”. This may suggest that these side effects occur only if alcohol is consumed when taking the drug.

Instead, the manufacturer should consider adding intervening information or changing the order of the presentation so that it is clear that the side effects listed are not caused by drinking alcohol while taking the drug.

Remember to keep your labeling and all related sales and marketing material consistent with your product classification guidelines. Always ask yourself the question: What is the FDA definition of my product? Is it a cosmetic, drug or device? If your marketing claims fit into those definitions, you will set yourself up for developing honest and FDA compliant labeling.

Material obtained from FDA guidance documentation. Image courtesy of FDA.gov; for consumers: protect yourself.