Why is social media compliance important?
Darshan Kulkarni
Kulkarni law firm
The recent warning and untitled letters have demonstrated that the FDA is reviewing websites and social media to find instances of non-compliant advertisements. Not following FDA regulations can expose companies to warnings, fines, and exclusions. Individuals may be forced to endure permissive and mandatory exclusions, prosecution under the part doctrine, and to criminal prosecution.
Egregious instances of non compliant and / or off label discussions may result in negotiations with the Justice Department, which may negotiate to require companies adhere to Corporate Integrity Agreements / Deferred Prosecution Agreements and / or using Corporate monitors.
“Make sure that your social media policy not only complies with FDA policies but also realizes that there are security laws, IP laws and labor laws.”
So why not just ignore social media?
Quite simply: The government including the FDA, the HHS or the department of Justice and your patients don’t care if you don’t know. If you should have known, you are expected to have known.
Strategies for a Compliant Social Media Policy:
1. Have a comprehensive social media policy.
2. Decide who represents your company
3. Operational Boundaries
4. Decide the goal of your social media policy
5. Understand the current rules and follow them.
1. Having a Comprehensive Social Media Policy
Make sure that your social media policy not only complies with FDA policies but also realizes that there are security laws, IP laws and labor laws.
2. Decide who actually represents your company
There are often several competing interests who may "jockey" to represent the official company position - Marketing, sales, compliance, regulatory affairs etc. The company must decide whether it chooses to be represented by multiple accounts or a single account.
“…it is important that Companies evaluate whether their message renders it susceptible to FDA oversight.”
3. Operational Boundaries
The company must also further decide the "metes and bounds" around which this "representative" may operate. Must every discussion be "run by" legal and compliance? While that may the most compliant way to operate, such a "tight leash" may not be feasible. Thus, boundaries under which such individuals operate must be defined.
• Who is the representative allowed to talk to? (Just healthcare providers, or also patients?)
• What happens if adverse events are reported - who must these adverse events be reported to? Must such adverse event reports be re-directed?
• Will this promote a product, promote awareness of a disease state or promote the company?
• Will this account perform some type of risk mitigation?
Each of these are different goals and the "leeway" that may be necessary would likely be different.
4. What is the goal of your social media policy?
Depending on the message, FDA compliance may not be necessary. Specifically, FDA compliance is only required for certain types of messages, and the FDA does not have jurisdiction over other messages. So it is important that Companies evaluate whether their message renders it susceptible to FDA oversight.
5. Understand the current rules and follow them
FDA has repeatedly said that the rules are not changing. They have agreed to provide clarification of the already existing laws and regulations. Hence, instead of "waiting on the sidelines", understand the current rules and follow them.
DISCLAIMER: The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and / or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney-client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.
About the author:
Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance/ Regulatory Affairs, and a Juris Doctorate degree. He works with and/or for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory and/or compliance needs.
Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products- Regulatory Considerations.
You can follow him on twitter at @FDALawyers or visit him at the Kulkarni Law Firm.
Do you understand current FDA rules regarding social media usage?
