In his first remarks to FDA staff, newly sworn-in FDA Commissioner Scott Gottlieb, MD, said the agency would build on past progress and mission to address 21st-century challenges including the opioid crisis, rising drug prices, and modernization of how the agency works. He discussed the importance of ensuring that drugs, including complex biologic drugs, are affordable and accessible, and said it was important that the generic drug process isn’t being inappropriately gamed to delay competition and disadvantage consumers.
Gottlieb said that the FDA’s greatest immediate challenge is the problem of opioid abuse, a public health crisis of staggering human and economic proportion, and not one the FDA can solve alone. But the FDA has an important role to play in reducing the rate of new abuse and in giving healthcare providers tools to reduce exposure to opioids to only clearly appropriate patients. In the coming weeks, the Commissioner said, he would have more to say on how the agency will take even more forceful steps to address the crisis.
The agency needs to be patient-centric and science-based in all that it does, Gottlieb told staff, and said the FDA must make sure that it maintains the gold standard for regulatory science and independent, science-led decision making in all its efforts. “Looking ahead, we sit at a time of great promise,” Gottlieb said. “Among some of the reasons I’m so optimistic about our shared future are new scientific opportunities, like gene therapy and regenerative medicine that give us plausible hope that we might be able to actually cure many more diseases.”
Gottlieb noted that scientific advances provide better tools for the agency’s regulatory work, and emphasized the need for the FDA to modernize how it works to be able to meet evolving challenges. He believes that modernizing the regulatory process and making it more efficient can improve consumer protection and promote health.
To that end, Gottlieb said there is an opportunity to greatly improve FDA’s public health protection role through the Program Alignment being undertaken by the Office of Regulatory Affairs. “We look forward to achieving operational efficiencies that can improve our ability to fulfill our public health mission and protect consumers” to safeguard food and cosmetics, improve nutrition, and protect consumers and livestock from the emerging threat of antimicrobial resistance. He also emphasized the need to reduce the rate of smoking and protecting children from the dangers of tobacco use.
Of the several challenges facing the FDA, Gottlieb placed drug pricing at the top. “Too many consumers are priced out of the medicines they need,” he said. Although the FDA doesn’t play a direct role in drug pricing, the agency still needs to take meaningful steps to get more low-cost alternatives to market to increase competition and give consumers more options. “This is especially true when it comes to complex drugs and biosimilars,” he said. He noted that he planned to address the topic of biosimilars and generics in the coming weeks.
Gottlieb also discussed a mandate to be forward-leaning when it comes to evaluating safety and efficacy in view of emerging scientific insight and better analytical tools. He said that implementing the 21st Century Cures Act is a key priority and that steps must be taken to foster innovation and regulate areas of promising new technologies in ways that don’t raise costs of development or reduce innovation. “We must do all of these things without compromising our primary mandate to protect the public health.”