Dr. Gottlieb's FDA: A Call for Rapid Progress in Brain Disorder Treatment


On Friday, President Trump named Dr. Scott Gottlieb as his nominee to be the next commissioner of the U.S. Food & Drug Administration (FDA). This is a critical leadership position – one which oversees a $5B budget, over 14,000 employees, and ensures the safety and effectiveness of our medicines – and I am sure that over the coming days, many will opine about this choice.

While others will certainly speak to Dr. Gottlieb’s qualifications, I would like to touch on what I hope will be a critical feature of his agenda: Accelerating the development of treatments for psychiatric and neurological diseases.

When the FDA was founded in 1906, the average American life lasted 49 years, and leading causes of death included tuberculosis, influenza, and diarrhea. Thanks to hundreds of billions of research dollars and decades of tireless innovation, a century later, the average American lives until nearly 80 years of age, and many of those once fatal diseases can be treated by a routine trip to the pharmacy. From penicillin to the polio vaccine, with every generation of breakthroughs we’ve achieved, the nature and complexity of American illness has transformed. Today, many of the most acute threats to our well-being emanate from medicine’s last frontier: the brain.

From Alzheimer’s disease to depression, millions of Americans are struggling with debilitating and often life-threatening brain disorders. While brain diseases range in nature, they share a common ability to tear individuals apart from their own identity and ability to function effectively. Among other deficits, these conditions result in struggles with learning, working, thinking, concentration, memory, and behavior; they result in lost or unproductive time in the classroom, at the office, or at home with loved ones; they place a massive, nearly incalculable burden on our economy; they shorten lives; they rob potential; today, they are incurable.

For these millions of Americans (and the many more who love them), we are not making fast enough progress toward introducing new treatments for their diseases.

Today, new drugs being studied to treat brain disorders take longer, cost more, and are likelier to fail than nearly any other area of medicine. While Lundbeck has remained steadfast in our commitment to psychiatry and neurology, given the mounting risks, we’ve seen many other companies either scale back or depart brain research entirely over the last two decades. While in recent years the pharmaceutical industry has achieved awe-inspiring breakthroughs in areas like cancer immunotherapy, HIV and hepatitis C, we haven’t seen a new treatment approved for Alzheimer’s disease since 2004. This must change.

While this relative dearth of new medicines does not lie at any one party’s feet, the pharmaceutical industry, academia, and the FDA must come together to work differently, as the status quo framework for engagement has left us with an ever-expanding epidemic. From the measures we use in our clinical trials, to the way we incorporate patient feedback into the regulatory review process, to the patent protections and incentives we offer to entice psychiatric and neurological research investment, I hope that Dr. Gottlieb is prepared to treat brain disorders as the discrete, special, and urgent priority they are. If the right actions are taken, a century from now, history may well remember his tenure for the progress achieved on this front.

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