The Current State of Off-Label Marketing

The frank Agency Branding
Winter 2018
Selling dental pharmaceuticals becomes even more challenging when some of the drugs’ uses are off-label.

A provision of the Food, Drug and Cosmetic Act prohibits pharmaceutical companies from selling a drug if it is “misbranded.” From this, the FDA takes the position that a drug manufacturer’s statements about its product are limited to promoting its “intended use” – in other words, the specific treatment for which it was approved – even if the promotional statements from the manufacturer of the drug are true.

Some manufacturers have engaged in legal battles spanning from the late 1990s to now, citing the First Amendment as grounds to promote their products’ off-label uses without repercussion from the FDA. While many of these battles have been successful, some are still underway, leaving a number of regulatory hurdles to overcome. However, there are several positive ways you can stay in line with FDA regulations while getting the word out about your products.

Develop a High-Level Approach

If your product’s uses are mainly off-label, your safest bet is a generic angle. Messages that do not make any claims, but rather encourage consumers to ask questions and pique curiosity and interest can motivate consumers to explore more on their own. Whether they turn to the internet or their dentist with questions, your marketing should be the factor that motivates them to start digging.

Though messages will need to be vague, they don’t have to be boring. Use engaging visuals, video content, or even share relevant (if not directly related) information that doesn’t make claims, but rather provokes thought and self-directed research.

Bring in Social

Many pharma marketers stay away from social media entirely for fear of legal entanglements. But, with careful monitoring, social media can be a useful tool for engaging and informing your audience.

For branded channels in particular, keep your product’s safety information readily available. Some manufacturers even “pin” this information at the top of their Facebook page, so that it's always within plain sight regardless of when it was posted. While a branded page can mention the name of your drug, it can’t mention any claim information or off-label uses.

Additionally, you may need to heavily monitor engagement; if commenters begin to stray into discussion of off-label usage or adverse events, you may consider deleting or disabling comments to avoid any confusion.

Many manufacturers also employ unbranded channels as, even though off-label uses and even drug names are offlimits, there is more opportunity for community discussion and conversation. Again, there will need to be strict monitoring of comments, but this is a good forum to promote thoughtful discussion and share articles and resources (with the proper credit attached).

Target the Influencers

In 2017, Arizona became the first state to allow drug manufacturers to directly communicate off-label uses to insurers and medical or dental professionals. For those manufacturers outside of this state, you can still influence this sphere by circulating peer-reviewed journals and other in-depth studies on off-label drug uses. These will provide additional necessary research to benefit industry professionals without directly promoting products.

Working within the Parameters

The complexity and nuances of off-label marketing restrictions can make it feel like you’re navigating a minefield. The best methods of ensuring compliance are by staying up-to-date on the most recent developments, and allowing your legal team to help you interpret the best way to stay within the guidelines for your particular product.

Although many off-label restrictions are still in discussions, and some believe they may even be relaxed in the future, most manufacturers choose the wise route of playing it safe until concrete decisions are reached. And, with careful attention to your messages and a commitment to developing strong brand awareness without making claims, you can keep in step without pulling out of the game.

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