How is the regulatory field changing for MSLs and what can the MSL do to ensure they remain complaint?
I want to first thank the MSL Society for giving me the opportunity to answer a few regulatory questions. These questions are timely as I just attended a legal round-table in Washington D.C in which we reviewed and discussed a few pharmaceutical and medical device issues surrounding the industry. Of course, the first issue that was presented which directly impacts the MSL is off-label promotion. In regard to change, this topic is changing by gaining more attention in the legal arena. Companies and individuals are consulting outside counsel with more frequency on guidance on the topic of off-label promotion. One change that must be made is to promote awareness and increase “knowledge” on this subject matter. Though the majority of off-label promotion cases have transpired from rather limited causes such as poor communication and inadequate corporate training programs, more than a few categories of off-label marketing complaints were observed during a legal analysis during the round-table event. These included expansions to unapproved diseases, unapproved disease subtypes, and unapproved drug doses.
In recent times, off-label marketing of medical devices and pharmaceuticals has remained a prime focus for government investigation. The issues surrounding off-label promotion are twofold: first, it is an illegal activity that violates federal law; second, it places individual employees and the corporation in jeopardy. Infractions for off-label promotion can include incarceration and heavy fines for individuals and corporations. As a byproduct, off-label communication may also impose ethical dilemmas on innocent bystanders when these types of known communications occur. Because this activity is illegal, any person contemplating reporting such acts may well shoulder a heavy personal and professional burden – they also may confront the thoughts and threats of retaliation. It is indeed imperative that employees know what off-label promotion is, and what the indications for use are in the case of the specific device or drug they are promoting. Training employees to avoid not only engaging in off-label promotion, but also reporting its occurrence to management, is tantamount to taking that first fundamental step towards an effective off-label compliance effort. Reports have indicated that some leaders may not want to bring attention to their own internal practices of labeling, or lack thereof.
Statements relating to off-label promotion occur when discussions drift away from the indication. This is one of the most common issues relating to off-label promotion. Frequently, statements made by MSLs or sales representatives to customers result in off-labeling problems for device or pharmaceutical companies. Additionally, it must be noted that manufacturers can engage in off-label promotion through various other promotional mediums and marketing materials, such as; Web sites, sales brochures, direct-to-consumer advertising, and press releases.
The FDA and other government agencies may also look at and evaluate the following information sources to determine whether off-label promotion has occurred:
- Training materials that are presented by the company at professional conferences,
- Submissions to government agencies made in support of device reimbursement,
- Securities filings that include information about a product’s research and development or regulatory status.
Business Practices can also create off-label risk for a company. These practices include:
- Sales representative activities,
- Field medical activities,
- Reprint use,
- Third-party relationships,
- Consultant utilization,
- MSLs being utilized as an extension of Marketing and Sales to promote off-label use.
I have highlighted several internal issues that can be faced relating to off-labeling. I will add that external issues can also pose threats as well. One such example surrounds questions posed by physicians. Inquiries from physicians must be unsolicited requests for a company to respond to off-label uses. The response to any such unsolicited inquiry must be balanced—or include information about both the risks and benefits of the off-label use—and be commensurate with the scope of the question. A few companies may direct their MSL to answer the question with the aforementioned in mind. The answer would also be directed to the one who is asking the question. Any inquiry must genuinely originate with the physician in order for the company to respond legally, as this is from the guidance document. Companies should implement compliance strategies aimed at preventing off-label activities that could lead to heavy fines and worse.
Are global regulations for MSLs needed?
Yes, I would first like to bring to your attention that the first drafted guidelines will be released at the MSL Conference in Las Vegas. We have formatted a notice and comment section that resembles a legislative framework that led to the final draft. While there are off-label regulations and codes of practice in all countries, there are no black and white interpretations for MSLs. The drafted guidelines can be a reference and used by companies in a multitude of ways. The drafted guidelines set the stage to assist the MSL – it can be seen as the algorithm that may be followed by the MSL. We hope to see you in Las Vegas and join us on the release of the MSL guidelines. A special thank you to those who assisted in the construction and body of the drafted guidelines.
This information is for educational purposes only and should not be construed as legal advice or a legal opinion from the author. This information is my own opinion and not that of past or present employers.
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