Life science PhDs who aren’t happy in the lab, MDs who don’t find their passion in treating patients, and PharmDs who do not fancy a career as pharmacists have for years been choosing the path as Medical Science Liaisons (MSLs). As changes in the law, regulatory guidance, industry codes, and provider restrictions have limited the access of pharmaceutical sales reps to healthcare providers (HCPs), the numbers of MSLs have steadily increased and they play an ever more important role in developing and managing the relationship with healthcare key opinion leaders (KOLs) and providing HCPs with credible medical information.
In doing so, MSLs have to walk a fine line. Their role is purely scientific/educational: pushing off-label drug use and anything resembling drug marketing is strictly a no-go zone for MSLs.
Companies who encourage or tolerate their MSLs crossing the line into commercial territory do so at their own risk as a number of sizeable settlements by pharma companies has shown (review the list).
First Rule of MSL Compliance – Off-Label is Off-Limits
Arguably one of the biggest issues for MSLs is how to discuss off-label use of drugs. The law is clear: while doctors can prescribe drugs outside their intended use, it is illegal for pharma companies under the Federal Food, Drug and Cosmetic Act to promote their products for unapproved uses, i.e. off-label use. Same laws apply to Medical Affairs departments - and with that MSLs - that apply to their commercial counterparts.
“FDA holds the medical affairs department to the same standards as it does sales reps. It’s important to keep from blurring the lines between promotion and responses to unsolicited requests.” , Tom Abrams, Director of FDA’s Office of Prescription Drug Promotion (OPDP)*
For an MSL’s daily interaction with HCPs this means that they can provide truthful and scientific information about off-label use if they receive an unsolicited request from the HCP. Per FDA Guidance unsolicited requests are define as “those initiated by persons or entities that are completely independent of the relevant firm.” If a doctor asks an MSL about data the company might have about off-label use of a drug, the MSL can provide “truthful, balanced, non-misleading, and non-promotional scientific or medical information” about the off-label use. They cannot, however, under any circumstances, promote the off-label use of the drug.
The fine line to walk here is the distinction between allowed unsolicited and prohibited solicited requests.
The FDA considers a request for off-label information to be solicited if it is prompted in any way by the MSL or another company representative. The FDA’s definition of “any way” is rather broad and includes obvious prompts such as “why don’t you ask me about off-label uses of the drug?” to a situation where an MSL is presenting data on off-label drug use at an event which in turn prompts questions from the audience.
For MSLs, who don’t want to run afoul of the FDA, solicited discussions of off-label drug uses – even on a purely scientific level – is off-limits.
Second Rule of MSL Compliance – Stay Strictly Scientific
With two teams – sales reps and MSLs – out in the field calling on many of the same HCP the other important MSL compliance issue is to stay strictly on the science side of things and avoid veering into commercial territory.
While this sounds straightforward the lines can get blurry at times. Is discussing clinical trial data with a KOL at the company’s (promotional) booth at a medical conference promotional or scientific? Can KOLs attending a company sponsored scientific education program be treated to a round of golf, a fancy dinner, or tickets to a show? Where does dissemination of scientific facts end and creation of demand for the product begin, especially if the scientific facts look really promising?
No rigid set of laws and requirements exists that dictates how medical affairs departments should be structured and operate and so the industry has developed rules and guidelines to help companies navigate this minefield between increased public awareness and regulatory scrutiny.
The Pharmaceutical Research and Manufacturers of America (PhRMA) have developed a Code and the Medical Science Liaison Society (MSLS) has published Guidelines (link here) designed to help pharmaceutical companies and their employees navigate these difficult questions. From KOL planning, to rules about joint MSL/sales reps visits of HCPs, from the dos and don’ts of conducting KOL meetings to the definition of “items of value”, these guidelines serve as a “reference for appropriate internal and external activities for Medical Affairs Leadership, MSL management, as well as MSLs.”
Yes, Pens and Mugs Are Items of Value
To close the loop: MSL should not have scientific discussions with KOLs at conference booths otherwise staffed by their colleagues form the commercials side. Paying for recreational activities, such as golf, is not consistent with a meeting purely focused on substantive scientific exchange, MSL and sales reps should never visit an HCP together, except in very limited circumstances, and even small things like pens or mugs are considered “items of value” without educational value and should not be given to the HCP or their staff.
While the basic rules for MSLs seem simple: don’t talk about off-label drug use unless asked and don’t do anything that might make you look like one of your colleagues in sales and marketing, the devil, as always, is in the detail.
To make matters worse, the details are still changing as companies push limits and explore new ways of communicating with KOLs and – increasingly - patient opinion leaders.
The last word has not been spoken and the last court case likely not been decided. Medical Affairs departments are well advised to develop their own set of policies based on the published guidelines and make sure the lines don’t get crossed.