Are you promoting products virtually in the COVID era?

If yes, here’s what you need to know.

COVID-19 has changed the way health care professionals (HCPs) and industry interact. Many providers do not allow company staff on-site. As a result, pharmaceutical and medical technology makers are promoting products virtually via Zoom and similar platforms.

Despite some challenges, this new way of conducting business is working. Some companies even prefer the new way due to cost and time savings. Is conducting speaker bureaus, conventions/trade shows, trainings, education, patient programs, and similar programs the new normal?

The same laws apply to online meetings as face-to-face interactions. However, there are new regulatory questions raised by remote meetings. Here are a few that we receive frequently for you to consider.

Frequently Asked Questions:

Many pharmaceutical and medical technology companies are ordering lunches to be delivered to an HCP office and then having a sales representative conduct a Zoom educational session while the HCPs eat. Our view is that providing meals in this fashion is relatively low risk as long as the following safeguards are in place.

    • Provided in conjunction with the provision of important scientific information and as a convenience to HCPs, e.g., during their lunch hour.
    • Occasional and provided as a business courtesy in a manner conducive to informational communication.
    • Modest as judged by local standards and cannot be part of an entertainment or recreational event.
    • Provided without intent to gain favor with an HCP or to reward them for future or past purchases or referrals.
  • Many companies are limiting meals to $20 per person for in-office catering. Note that New Jersey has a $15 limit for breakfast and lunch and that Vermont bars meals to health care professionals. There are many other restrictions.
  • Get an estimate number of attendees so that catering orders are as precise as possible. The idea is not to feed HCPs or other office staff with leftovers after the program.
  • Unless you have an automated solution used for tracking meals and attendance, identify a contact person at the facility and send them a sign-in sheet in advance of the meeting. Arrange to have them scan and email it back to you once completed. Be sure to review the sign-in sheet. Include federal, state and municipal restrictions on the sign in sheet.
  • Company staff should cross-reference the meal receipt with the sign-in sheet to ensure reasonable precision with food orders. Avoid over-ordering. The following in-person rules also apply to virtual interactions:
    • Copy review all materials (including recordings for future use)
    • Ensure that claims made are on-label, substantiated, truthful, and not misleading
    • Disclose important safety information, black box warnings, etc.
    • Do not disclose protected health information (PHI) and observe privacy rules, e.g., HIPAA, GDPR, CCPA, etc.
    • Disclose conflicts
    • Do not disparage competitors
    • No off-label promotion
    • Do not supplement or modify materials without prior approval
    • Consider including a voiceover of important disclaimers at the start of the webinar
    • Moderate questions and audience interaction

The same rules above apply. Also, consider the following.

  • In-office webinars with a small group are likely to run shorter than in-person meetings
  • Review speaker compensation arrangements to ensure payment is consistent with fair-market-value (FMV) and make sure you are meeting the Personal Services and Management Contracts Safe Harbor to the Federal Anti-Kickback Statute by developing a compliance program procedure on point
  • Audit your program periodically to ensure the rules you created are being followed

Yes. If your compensation arrangement includes payment for travel time, then the amount paid should be reduced so as to subtract the travel payment.

All of the same rules above apply. But be mindful that due to COVID, staff are likely to run into additional restrictions. If they are allowed onsite, make sure they are following the facility’s rules. Many institutions and regions address COVID differently. Some are more restrictive than others. Observe local requirements.

Staff should run a technology- and sound- check remotely prior to the webinar to ensure that the presentation will run smoothly.

Just with in-person meetings, staff and speakers should not proactively discuss off-label uses. Off-label subjects should only be discussed by qualified staff, e.g., Medical Affairs, and not commercial staff, in response to unsolicited questions.

In our view, a webinar is not the appropriate place to discuss an off-label subject because the speaker, for example, cannot have a one-on-one remote discussion with the person that asked the question—as required by FDA guidance. We recommend these questions be directed to a medical science liaison (MSL), or other qualified non-commercial staff, to discuss the question after the program. After which, the MSL should only respond to question asked, be objective, balanced, and scientifically rigorous, and note limits of data presented if any exist. Moderate audience questions. Watch for off-label inquiries.

Develop a speaker bureau standard operating procedure and a remote detailing policy for commercial staff. Train affected staff. The policy and procedure should be part of your overall compliance program and therefore be subject to periodic auditing.

Yes. Speaker programs are considered promotional programs by the U.S. Food and Drug Administration (FDA). HCP-speakers have a dual role: 1) treating HCP; and 2) a promotional agent of the manufacturer. Therefore, when working for the company, HCPs are responsible for compliance with the U.S. Federal Food, Drug and Cosmetic Act and company policies and procedures.

The same rules largely apply. We have received reports that virtual training, patient events, and meetings between company Medical Affairs staff and HCPs have been successful. Many industry conferences and tradeshows are going virtual. This means there may be fewer opportunities to promote products and engage in discussions with potential customers. We anticipate virtual tradeshows to evolve. Creative marketers will come up with new ways for companies to sponsor conferences and advertise their presence at them. We anticipate all of these on-line interactions to increase given the lack of HCP-industry facetime. Not all interactions are conducive to a virtual setting. Virtual labs have been tricky. It is hard to replace a hands-on experience. But some device makers are trying to do so using on-line simulators, for example.

Looking for an FDA Specialist?

Amanda Johnston, J.D., R.A.C.,
Sr. Attorney, Gardner Law

Brynn Stanley, J.D.
Associate Attorney, Gardner Law

Heather Potter, J.D.
Associate Attorney, Gardner Law

Mark Gardner, M.B.A., J.D.,
Managing Attorney, Gardner Law

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