Monday, March 23, 2009

REMS – Potential Competitive Advantage?

Ever since the FDA mandated the first Risk Evaluation and Mitigation Strategy (REMS) program for Celgene’s thalidomide product for treatment of cancer over 10 years ago, this program has been gaining momentum. It attempts to balance allowing patient access to important therapeutics but provide safety from potential abuse and/or side effects from drugs with prominent risk factors. Since that time, REMS applications have expanded and may be potentially applied to across classes of drugs such as opioids. While REMS restricts market penetration by limiting drug access to large patient populations, if correctly utilized it may be an important competitive advantage to stave off or delay generic competition beyond patent expiration. Even though the FDA is not supposed to allow REMS to deter generic competition, patient safety will be a decisive factor for allowing a competitive generic approval. REMS may also become a competitive advantage for securing strategic alliances if a Company has demonstrated competencies in this area. If REMS becomes a common occurrence associated with drug approvals, will CROs provide this as a service offering? This is a fascinating area to monitor over the next several years…

Further suggested reading:

No comments:

Post a Comment