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Regulatory Focus™ > News Articles > 2020 > 4 > Communication During a Pandemic

Communication During a Pandemic

Posted 24 April 2020 | By Alicia Whittlesey, Esq. 

Communication During a Pandemic

This article offers best practices for company communication during a pandemic, such as the current COVID-19 global emergency. The author emphasizes the need to make company communications responsible and thoughtful, not only in these challenging times, but always. Discussed are best practices for communication through many mediums, such as telephone calls, email and social media and doing so in such a way that the message is not misinterpreted, misleading, sent to the wrong person or persons or in any way puts the company reputation at-risk or, worse, puts the company in legal jeopardy.
 
Introduction
 
During the COVID-19 pandemic, many companies are finding a variety of ways to communicate with their customers. Organizations may use teledetailing/telemarketing through email, social media or other third-party functions for video conferencing. Communication could be verbal, written and electronic, such as texts, emails, telephone calls, teleconferencing, voicemails and handwritten notes. For example, since most life sciences companies cannot be person-to-person with their customers, emailing, picking up the telephone or sending a text message can be the next best option. Because these communications may have varying impacts than do traditional face-to-face meetings, it is important for them to be conducted under a company's policies, guidelines and trainings because they are permanent, recorded and easily searchable. No matter the form of communication, whether during our current pandemic state-of-affairs or not, these communications may pose legal, regulatory and compliance risks if the proper precautions are not taken. Below are some guidelines to remember when communicating either externally with customers or internally with employees. These communication suggestions are not in any special order of importance and can apply in many situations.
 
Essential elements to consider
 
The importance of content, context and tone
 
Have you ever sent an email that was meant to be funny only to have the recipient misunderstand and respond in an unexpected way? Imagine a customer misinterpreting a message, passing it along broadly and, particularly in today's sensitive environment, have the message misinterpreted and then results in a negative impact on the organization. Spending extra time to read and re-read written messages before they are sent can help avoid miscommunication. Before sending the message, think it over carefully to confirm it is clear and concise. State facts, avoid opinions and assumptions and be cautious of tone. Remember, written communications last forever and can be misunderstood later. Messages should be written clearly and simply and include enough context so they can be understood by both the intended recipients and others who may have access to the communication. When reviewing a message for tone, think about our current environment. Is there a chance the communication may seem “out-of-touch” given current social and economic conditions?
 
Know your audience
 
While crafting both external and internal communications, it is important to consider the audience. Are you targeting the appropriate audience with this message? If the communication is focused on a certain segment of your audience, are you using the appropriate message and providing the right amount of content for this audience? If you are communicating with a health care professional, patient, caregiver, regulatory professional, investor or another employee, is the communication being sent to the correct person? If using email, ensure the communication is being sent to the appropriate person. Did you type in the wrong address? Did your email “autofill” the wrong name? If you have multiple email accounts, confirm it is being sent from the correct account. This is particularly important if you are using a mobile device that may allow you to send emails from both your personal and work email accounts.
 
Responsible communication is not only about sending communications, but also applies when responding to a communication, particularly an email. Before sending any response, be sure you understand to whom you are replying. Is it appropriate to hit "reply all?" Do you know everyone included on that email chain? As a best practice, be sure to read all the way down to review the email chain to understand the entire context of the email and to avoid forwarding content inappropriately. If you are adding recipients to an existing distribution, be careful you are not inadvertently sharing confidential information in the body of the email or in email attachments and sending it to an unintended audience. Depending on the audience, a communication may need to be approved by an internal review committee or the legal, compliance or regulatory affairs departments.
 
Communicating responsibly is everyone's job
 
Ensuring corporate communications are sent responsibly applies to anyone and everyone within the company. It does not matter who you are or what your role may be. This may include CEOs, senior executives and even in-house lawyers who also should take every precaution and lead by example. Even if a communication was not intended to be offensive, a mistake could still have potential serious implications. Companies should not only consider what is being said within commercial and marketing communications, but also consider internal company communications, FDA or other government communications, investor communications and medical or scientific communications.
 
Possible negative effects of poor communication
 
For companies in the life sciences industry, the impact of poor communication can go beyond minor annoyance and inconvenience. Such communications may lead to possible ramifications from the US Food and Drug Administration (FDA), impact to the company's reputation and possible disruption of business activities along with other possible liabilities. Negative repercussions most commonly occur when the intended message is interpreted differently by either the receiving party or an unintended recipient.
 
What about passing along someone else's content?
 
I am often asked about best practices for companies wanting to send out articles or updates from sources outside their company. One may ask: “Why can't we just send that article that just came out about COVID-19? It says nothing about our company or anything about any of our products. It just shows ​we care about the situation and we want to share ​information that a customer may find ​useful.”
 
On the surface, the benefits of doing this may seem clear—the article doesn't discuss the sender's company or their products, and it still serves to communicate a sentiment about COVID-19, or any other situation, in what appears to be a low-risk manner. After acknowledging these points may be true, and although, to an extent, we want to encourage our internal teams to be proactive and creative, there are things to consider before sharing information ​found on the internet. Who wrote the article? Does it come from a reputable source? Did it go through a company's ​review process? Are you allowed to distribute it from a publication’s perspective? 
 
Companies should continue to be thoughtful about implementing responsible communications practices even when they are just passing along outside information.
 
Managers and team leaders also should consider how their employees are interacting with external parties or customers. Periodic check-ins and proactive communications are critical for employees to understand that although though the company is working in an environment of increased written communication, the importance of complying with company policies, rules and regulations has not changed.
 
What can companies do to help confirm promotional communications are compliant?
 
The first step is to always consider any claims or statements regarding efficacy or safety of a product. If communications include product names or claims, they may be viewed as a promotional communication that may require safety information, including a package insert and review by the relevant company review committee.  All promotional communications should be truthful, accurate and not misleading. They should be appropriately balanced with safety and/or risk information (fair-balanced), be consistent with FDA labeling and supported by appropriate data and substantial evidence.
 
Companies with no other choice but to communicate and share materials through electronic communications are developing creative ways for their sales force to have some autonomy, yet still act within the appropriate regulations, guidelines and company policies. This may include creating previously approved templates with "drop downs" of optional language that can be included within open fields or a list of topics the sales force can discuss with their customers without triggering the need for safety information or imply a promotional communication. An effective tactic for deploying this strategy is to create a list of best practices addressing tips for customer communications that are appropriate from legal, regulatory and compliance perspectives.
 
Staying compliant throughout the communication process can present complexities that may be difficult to navigate. For example, a member of the sales force may send a compliant communication, one following the appropriate training. However, the recipient of the communication responds and asks for more information or about a product. In this situation, the sender should determine if the question should be directed to medical information, or if there was a previously approved response that would be appropriate to use. Many companies also have implemented virtual training that include role playing while reviewing the appropriate "do's and don'ts" for communicating with customers. This format provides the opportunity for employees to ask questions. Such training is often used periodically and can be supplemented by an easily accessible guidance document through which employees can use as a quick reference.
 
Social media
 
What about social media? While the best practices discussed in this article also apply to social media, this is an area continuing to pose more challenges and risks for companies. Platforms such as Facebook, Instagram, Twitter and others present dozens of opportunities for people to send, ​react, post or comment on any given topic. ​A company is generally responsible for content appearing on social media if the profile is controlled, owned or created by that company or by someone ​acting on behalf of a company. Most companies have either a social media policy or appropriate guidelines addressing responsible communications on social media. Employees should consider their role when chatting with a friend, colleague or even a potential customer. In general, social media offers highly visible, very accessible communications where messages may inadvertently reach an unintended audience.
 
The bottom line
 
Regardless of the method or delivery, every communication must adhere to promotional rules and regulations. It should comply with any other applicable legal or regulatory requirements as well as internal approval processes and controls. For companies planning to "telemarket" there are also a variety federal and state laws, regulations and agencies to consider including:  the CAN-SPAM Act, Health Insurance Portability and Accountability Act, Federal Communications Commission, Federal Trade Commission, California Consumer Privacy Act and the Telephone Consumer Protection Act.  
 
Companies and employees should remember the importance of personal privacy and know whether their communication is subject to global or state regulations, which often depends on the location of the recipient. Before communicating with any customer or contact, the sender also should consider whether (or not) there is an established relationship with the contact. Consider the following:
 
  • Has there been previously documented contact with this person?
  • Would this person reasonably expect to hear from you?
  • Has this contact opted into company communications or provided consent to receive promotional information?
  • How was the contact information for this person obtained?
 
Managers should remind employees to always check with regulatory, compliance and/or the legal department to ensure the communication is compliant and appropriate and that there is permission to contact the specified individual.
 
Conclusion
 
While the challenges of communicating responsibly during a pandemic environment are evolving, encouraging employees to ask questions, maintaining open lines of communications with employees and implementing best communication practices can help the organization communicate more effectively and responsibly, not only during a pandemic, but also during “normal times.”
 
About the Author
 
Alicia A. Whittlesey, Esq., is counsel at Porzio, Bromberg and Newman PC and director of compliance services at Porzio Life Sciences, the firm's wholly-owned subsidiary. She is a member of the firm's life sciences compliance and regulatory counseling department. Her practice includes advising pharmaceutical, medical device and biotechnology companies on the laws, regulations and enforcement measures governing the life sciences industry in areas such as advertising and promotion, compliance, privacy, internal and external communications and interactions with patients, HCPs, payors and advocacy. For more than 15 years, Whittlesey worked as in-house counsel in the pharmaceutical industry providing legal, regulatory and compliance guidance on programs, policies and activities, including a key role in promotional and other materials review. She can be contacted at AAWhittlesey@pbnlaw.com.
 
Cite as: Whittlesey A A. “Communication During a Pandemic.” Regulatory Focus. April 2020. Regulatory Affairs Professionals Society.
 

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