5 FDA Guidance Best Practices for the Health Care Industry


An FDA guidance wake-up call

In our first installment of “On Label,” we introduced you to a health care marketer named Janine. As she continues to promote her company’s latest urology drug, Janine faces the day-to-day challenges of understanding FDA guidance best practices. She just developed an exciting and engaging social media campaign; however, it didn’t go entirely as planned in her first regulatory review.

Let’s check back in with Janine to see how she’s doing…

Janine just left a stage-one review with regulatory. She is frustrated because the review didn’t go well. The initial Twitter promotional materials were shot down by her regulatory affairs contact, Sophie, because the tweets accidentally expand the indication. Worse, Sophie said using Twitter would probably never be advisable since the drug has too many contraindications to list in 140 characters. Fair balance and all that.

In response to Sophie, Janine pointed out that FDA’s “Twitter Guidance” says it “does not establish legally enforceable rights or responsibilities” and “should be viewed only as recommendations.” Those are the exact words of the guidance. 

Sophie replied, “I’m not sure you understand what the guidances are.”  

Janine feels bad for pushing back, but Sophie’s cryptic comment doesn’t exactly help Janine understand FDA guidances any better. She’s not sure what to do, and she’s too embarrassed to ask Sophie to explain. Regardless, she needs to get up to speed quickly so this doesn’t happen again. 

The entire situation still has her wondering, “If it’s just a ‘guidance,’ why do we have to follow it?”

Janine isn’t the only healthcare marketer to feel mystified by FDA guidances. Maybe you still find yourself scratching your head over these all-too-important documents. To start, let’s walk through the five FDA guidance best practices every healthcare marketer should know.

1. FDA guidances are to be used as a blueprint for understanding federal regulations.

Let’s start by going back in time. In the 1960s, FDA established its framework of public health protections for drug and device promotion. These rules are known as the Code of Federal Regulations, and they govern what we can and can’t do in healthcare marketing.

Now, FDA periodically drafts a separate document, a “guidance,” to explain how FDA interprets those laws. It is essentially a blueprint on how to understand those laws and how to apply them to device and drug promotion. A good practice for utilizing these FDA guidances is to have them guide your understanding of those rules and regulations.

2. You should follow FDA guidances closely.

The name “guidance” itself doesn’t exactly convey the weight that each one carries. It is true that the actual regulations, which the guidances interpret, exist separately. However, FDA guidances still represent a significantly authoritative voice in drug and device promotion.

A good FDA guidance practice is to follow those interpretations closely. If you do, you should be safe. Disregarding those interpretations — deciding that you can interpret the laws for yourself — opens you up to litigation and FDA enforcement actions, both of which are extremely costly in time and money. Unless you love defending yourself in legal battles, then you should follow the guidances as closely as possible.

(Remember: FDA can even prosecute employees and not just their companies for violative promotion.)

3. It’s important to stay up-to-date on the latest guidances issued by the FDA.

There are multiple ways to keep up with FDA guidances, but a good practice that we recommend is by simply following @US_FDA on Twitter. Through this channel, FDA will announce when they are issuing a new one, so you’ll always stay up-to-date on the latest guidance. You can also visit FDA’s website and use the filters to find the most recently released guidances relating to your area of interest.

4. If you have thoughts on what should be addressed in an FDA guidance, you are encouraged to issue a comment.

Fortunately, FDA is very interested in getting it right: guidances are open for comment. That means you can let FDA know what should be addressed in a guidance or what you think of the current version during the commenting period (typically 60 days after the draft guidance is published). This ensures that FDA can consider other perspectives on a guidance before the final version is issued. If it’s issued, I should say. Sometimes a final version never gets published, in which case the draft guidance can be viewed as the last interpretation FDA gave the public.

5. Use FDA guidances to help guide your messaging strategies in a compliant way.

Sure, the guidances often feel cumbersome. They occasionally stand in the way of catchy promotional tactics. But they also represent a concerted effort on the part of FDA to help us promote our products while still protecting public health.

It’s a good practice to become familiar with FDA guidances and use them as a blueprint for your drug and device promotion. Don’t fall prey to the consequences of interpreting regulations for yourself; it can cause a lot of headaches for you and your brand.


Ultimately, following all of these FDA guidance best practices can help you guide your messaging strategies in a compliant way, improve the lives of others and protect public health.

They truly offer a structure to the poetry that is your work.

Until next time.

 

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