Scott Gottlieb started his first full week as FDA commissioner by laying out some goals and guidelines for the agency now under his direction, hoping to alleviate some concerns he’s been hearing about the future. In an all-hands speech to staff on Monday, Gottlieb reiterated some now familiar themes on what he hopes to accomplish, and how everyone at the FDA is now expected to lend a hand.
Aside from some health initiatives on smoking and combating the opioid addiction crisis in the country, Gottlieb pledged to find new ways to lower drug prices, pushing through complex generics and biosimilars while laying the groundwork to prevent any more sweetheart deals to delay the arrival of low-cost knockoffs, implying that he’s preparing to take action on that front.
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.
In the area of new drug development:
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 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.
Gottlieb also highlighted a changeup in the Office of Regulatory Affairs. As Bloomberg reported earlier Monday, Gottlieb is focusing workers on specific areas like drugs and devices in order to achieve greater expertise as they inspect facilities and probe consumer complaints, abandoning the old regional focus with shared responsibilities.
“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,” noted Gottlieb.
None of this is a dramatic departure for the FDA. But Gottlieb is also sending the message that business as usual won’t be the theme for his tenure as head of the FDA. His immediate predecessor, Robert Califf, offered a quick thumbs up for getting started early with a reorganization.
— Robert M Califf (@calif001) May 15, 2017
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