Five things you didn’t know about off-label sales compliance

Maureen Shaffer

Good Promotional Practices

Off-label sales compliance is difficult. There is subtlety to staying on message. Pharma sales representatives are highly mobile and verbal. Compliance and regulatory departments love paper to convey messages because they can match them up to corresponding policies. This makes the marriage of the two functions challenging.

Here are five things you may not know but should about Off-Label Sales Compliance to help sales effectively sell while staying inside the compliance lines.

1. Off-label sales compliance is not about sales prevention.

Compliance, as defined by Merriam-Webster’s Medical Dictionary is, “the ability or process of yielding to changes in pressure without disruption of structure or function.” It is about creating behavioral change, or yielding WITHOUT disruption of the primary purpose of moving product into the marketplace to improve the lives of patients. Talented sales reps are not going to be natural mini-lawyers or regulatory gurus. We want them to sell. We need to encourage their natural verbal gifts and forward motion to support the business. To do this, we need to move beyond policies to behavioral change. Internal departments need to respond to the increasing regulatory pressures by developing a methodology to ensure positive behavior change with minimal sales disruption.

2. Tone at the top is okay, Tone at the middle is best.

Though it must start at the top, a video from the CEO is not how you embed tone throughout the organization. Ethical decisions and sales promotion must be interwoven throughout your organization. The best way to do this is to understand that repetition creates memory and belief. You must have sales executives train their managers, who then train their representatives, according the CCOs from Intel and AIG at a Dow Jones Global Compliance Conference. Compliance and regulatory are not peers with sales. And, they are not their leaders.

“…cognitive psychologists have shown that we can only retain seven things at a time.”

3. Off-label sales compliance must be simple.

Yes, we need to simplify compliance. Some very smart cognitive psychologists have shown that we can only retain seven things at a time. What seven things do you want your reps to remember about off-label every day? Regardless of your religious leanings, if Christianity can sum up the Bible in 10 commandments, certainly we can come up with seven keys to prevent off-label promotion. If we make it too complicated, it seems impossible to comply. Here’s a good, three-point place to start on your seven sales principles:

Your oral and written statements must be:

• Truthful and non-misleading

• Fair balance between benefit and risk

• Communication of material facts

Then, drive these seven, or less, key principles into the minds of sales with illustrative stories and real-life scenarios. Ideally, try to add some humor as it enhances memory.

4. Off-label role playing is the foundation for sales compliance.

Never heard of role-playing for compliance training? Let’s flip it over. Ever heard of a sales person learning to sell by reading a how-to manual? Asking sales to read a policy or sit through a PowerPoint slide presentation and then use this training in their day-to-day conversations is like asking them to learn to sell by reading a book. It does not work. If you want sales to be compliant during a conversation, those conversations have to be practiced. The best sales representatives learn by doing.

In addition to new hire training, when new information is available, new boundaries need to be practiced. Have sales team managers role-play scenarios with team members, such as before and during:

• New launches

• Major scientific meetings

• New scientific studies

Sales reps learn pitches and how to convey educational information through role playing. They will also learn how to avoid obvious and subtle off-label promotion through practice and observation. Of course, have them document this important training as well.

“…but if it doesn’t slow you down and in fact makes your life easier while protecting you from individual liability and prosecution, isn’t that a good thing?”

5. On-message needs to be easier than off-label.

Sales people want to do what is best for their customers while keeping their day jobs. What is on-message vs. off-label needs to be reinforced in their daily habits. Try these ideas:

• Make it easy for sales to continuously learn with a weekly or monthly texting campaign of Dos and Don’ts. Or, consider texting a quick scenario for them to read and discuss with their managers once a month.

• Give them a place to safely ask a real-life question about off-label communications and get a straight answer quickly. Perhaps legal or compliance could have an email address that they check frequently or a phone number to call.

• Provide a straightforward and quick reply to all customers who call Medical Affairs to request articles or topical information so sales is not tempted to provide the article more quickly.

• Go out on a limb and work with marketing or PR to devise a communications program or an e-learning app that keeps on-label information front of mind and fun.

By understanding these five points about off-label sales compliance, you and your company are in a better position to avoid fraud and abuse, and the associated penalties, and prevent serious injury both your business and your livelihood.

Excellent Resources

1. Your own sales force or distributors

2. Good Promotional Practices

3. AdvaMed MTLI courses


5. Dow Jones Global Compliance Symposium

About the author:

Maureen Shaffer is the Vice President of Life Sciences for Prolifiq. She focuses on providing mobile software and solutions to help sales and marketing professional drive sales, save money and comply with the increasingly complex web of regulations governing healthcare practitioner (HCP) communications. She is also the Executive Editor and Publisher of, the collaborative and cross-functional blogging site for medical devices (medtech) and pharma covering promotional best practices in the increasingly litigious environment and runs a GPP LinkedIn group at Additionally, Maureen spent 20 years in marketing at cardiovascular medical device companies, mostly emerging growth and startups.

What’s your top tip for off-label sales compliance?