Robert Califf and Betsy Nabel discuss the FDA’s need for feedback from experts at academic medical centers, such as the Brigham.

Robert Califf and Betsy Nabel discuss the FDA’s need for feedback from experts at academic medical centers, such as the Brigham.

On Nov. 1, Robert Califf, MD, commissioner of Food and Drugs at the U.S. Food and Drug Administration, visited the Brigham and spoke about several topics that were top of mind for the FDA and BWHers, including the need to expand the scientific workforce, improve mental health care and address the opioid crisis.

Califf was joined by BWHC President Betsy Nabel, MD, for the discussion in the Building for Transformative Medicine. The event was open to all BWH staff. Califf, who was named commissioner earlier this year, is traveling around the country to visit academic medical centers and learn more about their work.

“Dr. Califf’s visit provided great insight into what we can achieve when we work collaboratively,” Nabel said. “Today was only the beginning of what I hope is an ongoing conversation and exchange of ideas.”

During the discussion, Califf, who previously worked at Duke University as a cardiologist and clinical researcher, emphasized the FDA’s need for feedback from clinicians and researchers to help guide the agency’s policies. As the FDA works on several different priorities, having insights from experts in various areas of science and medicine is imperative, he said.

“Since I began working at the FDA, it has become obvious that a lot of our work is very dependent on the people who are either trained in academic medical centers or who receive care through these enormous integrated health systems that are evolving around academic medical centers,” he said. “Certainly, Partners HealthCare is an early and premiere example of this phenomenon.”

The FDA is responsible for protecting public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices.

As commissioner, Califf said his top priority is building up the scientific workforce to ensure the FDA continues to make informed policy decisions.

“We need a vibrant ecosystem, which is cognizant of benefits and risks and continually interacting with the FDA,” Califf said. “We need to constantly update the knowledge base so we can do the right thing.”

The forum concluded with questions from BWHers. Brian Mullen, PhD, Innovation Strategy manager in the Brigham Innovation Hub, asked about the regulation of technologies, such as apps and games, to improve mental health. Apps and games need to be regulated to ensure that people are not buying products that don’t work, Califf responded.

Mental health and substance abuse are top-of-mind issues for the FDA, Califf added, acknowledging that the federal government needs to continue improving its work in those areas.

“Problems like depression are chronic, and while there are behavioral and social components, there’s also a need for much better pharmacologic therapies,” Califf said. “We need to invest in developing the pipeline much like we did with cancer 45 years ago.”

Califf also spoke about the opioid crisis and referenced the FDA’s comprehensive action plan, available online at, which outlines the steps the agency is taking toward reducing opioid misuse and abuse. He said the focus needs to be on increasing the number of prescribers who are trained in pain management and appropriate ways to prescribe opioids.

“There has to be a nonaddictive way to pharmacologically treat pain,” he said. “We all have to work together to figure this out.”

Michael S. Sinha, MD, JD, MPH, a postdoctoral fellow in the Program on Regulation, Therapeutics and Law at BWH, attended the talk because he is part of a research team in the Division of Pharmacoepidemiology and Pharmacoeconomics at BWH. The division conducts empirical research – a type of research based on observations in the field, as opposed to laboratory work – and legal policy analysis in the pharmaceutical industry. He enjoyed the candid discussion with the commissioner.

“We have a lot of respect for the FDA and its work,” Sinha said. “Dr. Califf joined the FDA after a long career in academic cardiology at Duke, and I admire his willingness to step into a position, for which criticism is abundant and praise is rare, with an opportunity to positively impact the regulatory landscape in the United States.”