Life science companies including drug and device companies have paid multi-billion dollar fines resulting from non-compliant promotion. The FDA, as part of its expectations of quality expect that companies will have a system in place to ensure that their promotions meet FDA expectations.
Part of demonstrating quality is to have a quality system in place. The American Society of Quality (ASQ) recommends that companies adhere to the Plan Do Check Act System which is a standard feature through pharmaceutical and medical device companies.
As part of the system companies are expected to have an appropriate training program, with specific policies to train their teams in promotional compliance. Once both are appropriately created, it is important that this training program, and the policies be updated based on the many changes that the FDA and courts propose from time to time.
In addition to appropriate training and policies, it is important that companies have a system in place to identify non-compliant promotional and non promotional materials. This is often called a promotional review committee (PRC), Medical Legal Review (MLR) or “medical legal” or “med-reg” for short. As is evident, there are typically 3 core members to this team:
- Medical: These individuals typically work in the Medical Affairs department and are typically individuals with terminal doctorates such as a Doctorate in Pharmacy, Medicine or PhD in the life sciences. They are typically expected to review a proposed piece to evaluate whether the proposed promotional/non promotional piece is compliant with FDA/ FTC expectations and the approved package insert. Depending on the specific type of claim being made – different levels of proof may be required. Recent court rulings have determined that from time to time companies may be able to go beyond the package insert provided that such claims are “truthful and non-misleading”. Medical is typically expected to evaluate such claims.
- Legal: These individuals are attorneys with a Juris Doctor degree and typically work in the legal department, though attorneys may from time to time be called from the compliance department. They may often be asked to evaluate if the proposed piece or program might violate a number of laws including HIPAA, the False Claims Act, Anti-kickback law, preexisting agreements etc.
- Regulatory: These individuals are often well versed with FDA requirements and review claims in the context of the FDA’s expectations.
It is important to recognize that while companies have traditionally tried to keep the MLR function in-house, it has been difficult to do so due to costs incurred and the lack of qualified personnel. The Kulkarni Law Firm has hence begun providing this as an outsourced service for large and small companies. Email us today at Darshan@conformlaw.com !