Washington, D.C. – U.S. Senator Susan Collins, a member of the Senate Health Committee, questioned Dr. Robert Califf at a hearing to consider his nomination to serve as Commissioner of the Food and Drug Administration (FDA).
Senator Collins commended Dr. Califf’s pledge to improve the FDA’s preparedness for future public health emergencies if he were confirmed to lead the agency. She remarked that one way to accomplish this goal would be to reduce the United States’ reliance on foreign manufacturers to produce pharmaceuticals.
“For a number of years, I have been very concerned that the United States’ drug market is increasingly reliant on the manufacture of active pharmaceutical ingredients at facilities overseas,” said Senator Collins. “In fact, the FDA in 2019 testified that 72 percent of the facilities that manufacture APIs are located overseas, a lot of them in China and in India. In addition, we know that China has virtually cornered the market on the manufacture of antibiotics.”
Amid the COVID-19 pandemic, Senator Collins raised the alarm that countries like India and China were hoarding medicines destined for the United States. At the hearing, she emphasized the importance of reforming the medical supply chain and incentivizing manufacturers to relocate their facilities back in the United States. She also asked Dr. Califf to express his thoughts on the vulnerabilities in the supply chain.
Dr. Califf agreed that bringing back manufacturing jobs is part of the supply chain solution. “We need the supply chain to be secure and resilient in multiple directions and a transparent system for knowing where things are in the supply chain, which we currently do not have. I would mention one other thing: manufacturing in place is an exciting technology that people have been working on, and the idea that you can make a pill now with a small machine in a local area is something that I believe is coming and we need to accelerate that as quickly as we can,” Dr. Califf responded.
Senator Collins, who is the founder and Co-Chair of the Senate Diabetes Caucus, also raised the issue of the lack of medical therapies for patients living with Type 1 diabetes. She observed that the FDA has reviewed and held two advisory committee hearings on therapies coming down the pipeline. One potential therapy would delay the onset of Type 1 diabetes and improve insulin production in high-risk individuals. Another cellular therapy created from a donor pancreas would help those suffering with severe hypoglycemia.
Senator Collins asked Dr. Califf, “How would the FDA under your leadership continue to foster cutting-edge science at the various centers we have created for Type 1 diabetes therapies and devices?”
Dr. Califf answered, “We would like to continue this very healthy relationship between the patient community, the industry that makes products, and the regulators who have to determine if the products are safe and effective.”
Dr. Califf went on to emphasize the importance of an engaged patient community, which incentivizes individuals to participate in clinical trials and creates a reliable, evidence-based model for practitioners.