Scott Gottlieb, MD, the new Commissioner of the US Food and Drug Administration (FDA), addressed his staff for the first time and outlined key priorities of the agency, including improving it through the program alignment by the Office of Regulatory Affairs, addressing drug pricing through increased competition, implementing the 21st Century Cures Act, improving the generic-drug review process, and addressing opioid abuse.
With respect to the overall mission of the FDA, Dr. Gottlieb said: "... [W]e have an opportunity to greatly improve FDA’s primary and principal public health protection role through the Program Alignment being undertaken by the Office of Regulatory Affairs (ORA). As ORA’s mandate becomes more complex and more global, we look forward to achieving operational efficiencies that can improve our ability to fulfill our public health mission and protect consumers."
Dr. Gottlieb also outlined challenges that the agency must address as part of its mission, including how it can contribute to greater competiition for lower-cost drugs.. "..[T]oo many consumers are priced out of the medicines they need. Now, I know FDA doesn’t play a direct role in drug pricing. But we still need to be taking meaningful steps to get more low-cost alternatives to the market, to increase competition, and to give consumers more options. This is especially true when it comes to complex drugs and biosimilars."
He also addressed the generic-drug review process and alluded that he would address this topic more specifically in the near term. "We also need to take steps to make sure the generic drug process isn’t being inappropriately gamed to delay competition and disadvantage consumers. I hope to have much more to say on this topic in the coming weeks."
He also underscored the FDA's role to encourage innovation, particularly as it relates to recent legislation, the 21st Century Cures Act. "In other areas, Congress gave us a clear mandate to be forward-leaning when it comes to how we’ll evaluate safety and efficacy in view of emerging scientific insight and better analytical tools. Implementing the 21st Century Cures Act is a key priority. We need to make sure we’re taking steps to foster innovation and regulating areas of promising new technology in ways that don’t raise the cost of development or reduce innovation. We need to do all of these things without compromising our primary mandate to protect the public health."
Dr. Gottlieb also addressed the opioid crisis, in what he termed as the agency's "greatest immediate challenge." "But unquestionably, our greatest immediate challenge is the problem of opioid abuse. This is a public health crisis of staggering human and economic proportion. The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in giving healthcare providers the tools to reduce exposure to opioids to only clearly appropriate patients, so we can also help reduce the new cases of addiction. Addressing this tragedy is going to be one of my highest initial priorities. Now, I know FDA has already taken many important steps to address the opioid crisis. But the epidemic has continued to grow. I’ll be working with FDA’s senior career leadership and in the coming weeks hope to have more to say on how we take even more forceful steps to address this crisis."
In concluding comments, he emphasized the continual overarching principal by the FDA to use risk-based approaches in its work and to pursue patient-centric and science-based decision-making. "In tackling these and other issues, we need to always be risk-based in our work. We need to make sure we’re getting the most public health bang for our efforts and the resources that we’re entrusted with. I know we only have limited resources to do these hard tasks. And I also know, from my prior work at FDA, how much we accomplish with the limited tools and resources we have available to us. We need to be patient-centric and science-based in everything we do. And, we must make sure that in all our efforts, we maintain the gold standard for regulatory science and independent, science-led decision-making, all led by a strong career workforce."