Facet Attends the Food and Drug Law Institute (FDLI) Annual Conference

In May, Dr. Jason Mercer attended the Food and Drug Law Institute (FDLI) Annual Conference.  FDLI brings together legal and regulatory professionals that work within FDA regulated industries.  We are excited to attend this conference to hear from and interact with FDA staff, the FDA legal community, and other peers in our industry to share insights and learn of coming initiatives.  This year included presentations by FDA Commissioner, Robert Califf, FDA Chief Counsel, Mark Raza, and CDER Director Patrizia Cavazzoni.  Hot topics included regulation of Artificial Intelligence, development of Cell and Gene Therapies, current issues in development for rare and neurodegenerative diseases, pending Supreme Court decisions expected to impact the FDA, and the annual favorite Top Cases in Food and Drug Law session.   

In June, Dr. Mercer attended the Reagan-Udall Foundation for the FDA’s workshop titled: Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest.  The conference brought together healthcare and policy professionals to discuss both the potential for ketamine to be beneficial for the treatment of psychiatric disorders, pain, and other disorders.  There is positive data to indicate that ketamine, which is currently approved as an anesthetic and sedative, may be beneficial in other indications.  However, there are safety concerns and uncertainty about dosing that will need to be addressed for FDA-approval for new indications.  The workshop explored some of the main challenges in generating this data, including the lack of economic incentive for commercial development due to the lack of intellectual property and wide availability through the generic market and from compounding pharmacies.  Finally, the workshop addressed the growing concern over the proliferation of ketamine clinics nationwide that advertise ketamine as a treatment for a wide variety of conditions.