Medical Affairs, and MSLs have traditionally been the only individuals within a life science company who can engage in discussions about the off-label uses of a product. This role has, however been challenged by the Caronia, Amarin and Pacira decisions that question whether only Medical Affairs can provide such information.

In light of the court decisions, companies have questioned whether Medical Affairs may be combined with the sales force to effectively become “super sales reps”. This would be a mistake. 

A combination of sales and medical affairs would be a mistake. Medical Affairs and MSLs provide value beyond simply discussing a product’s off-label indication(s). These individuals are trusted by companies to make clinical and scientifically sound decisions as well as guide the company appropriately based on the approved indication of the drug or device. Additionally, these individuals are also trusted by clinicians. This is unlike the perception of sales people who are typically entrusted to increase sales and are therefore not typically trusted in the same way that the medical affairs staff is often trusted.

When a company is trying to evaluate whether the claims being proposed meet FDA requirements, it is important that the medical affairs department help with evaluation of these claims.

Internal MLR review

The Medical Affairs department is often the group responsible for ensuring that the science associated with a product reflects the latest clinical and scientific information. It is hence important that companies that continue to retain their MLR department have a representative of the medical affairs department serve to evaluate the science behind the claims being made. The medical affairs representative will be able to make intelligent decisions as to whether the claims being made are sufficient to satisfy the “truthful and not misleading” standard.

Investigator Initiated Research (IIR)

Evidence suggests that IIR initiated by marketing and sales is prone to abuse and may be deemed to be a quid pro quo and potentially a violation of the Anti-Kickback and False Claims Act. Medical Affairs, in collaboration with the Independent Review Organization (IRO), may be able to appropriately manage IIRs by enacting policies and reviewing actions to ensure compliance with these policies.

Answer difficult questions

As previously stated, it is important that companies appreciate that prescribing and non-prescribing clinicians appreciate conversations with other clinicians. Accordingly, when medical affairs departments respond to questions, it tends to be valued more than information provided by sales people who have a vested interest in making the sales. The discussions by medical affairs is hence often more nuanced since they can understand, empathize with and address the needs of the prescribing and non prescribing clinicians. It is hence important that medical affairs continue to exist as a stand alone entity.

These individuals are trusted by companies to make clinical and scientifically sound decisions and guide the company appropriately. Additionally, these individuals are also trusted by clinicians who see them differently from sales people who are entrusted to increase sales. One could even argue that having and promoting ones medical affairs department as an unbiased entity may create goodwill for the company and have independent value.