Healthy Innovation, Safer Families: FDA's 2018
`Strategic Policy Roadmap
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`anuary 11, 2018
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`I am delighted to share FDA’s 2018 Strategic Policy
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`oadmap,the productof a close collaboration
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`amongthe Agency’s centers. This document
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`provides an overview of someof the keypriorities
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`e will pursue together to advance FDA’s public
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`_health mission.
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`| Read the 2018 Strategic Policy Roadmap (/media/110587/download)
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`|
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`Manyofthese efforts are already underway,andwill be further advanced in 2018, while other
`policies outlined in this documentwill be initiated during the coming months.
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`The countless, critical functions FDA providesevery day to our fellow citizens are, at times,
`obvious andat other times indiscernible, even to those touchedbyour efforts. The work we do
`provides Americans with better ways to improvetheir health and welfare, helps families protect
`their children, and enables consumers to make safe and healthier choices about the products
`they use and the foodsthey feed to their families.
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`Wehaveselected the specific policy efforts included in this Roadmap because webelieve they
`embodythe overall scope and spirit of our collective efforts as we work together to pursue FDA’s
`public health mission. Each one of us has an importantrole to play in achieving this mission.
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`Our workis taking place during an inflection point in both science and policy. We have more
`opportunityto deliver on the promises of science than at any time before. Gene- andcell-based
`therapies hold the opportunity to treat a wider rangeof debilitating disorders, and deliver
`outright cures to intractable diseases. New gene-based technologies enhancethe ability to
`increase crop and animal yields and identify foodborne and zoonotic outbreaks and trace them
`to their source. Mobile monitoring can offer patients and providers timelier and moreactionable
`clinical information. More targeted medicines allow human and animal patients to realize more
`of the benefits of new drugs, with fewerside effects. At the same time, new medical devices are
`helping to restore mobility to paralyzed patients and allowing more people to live lives that are
`less hindered from the impact of chronic ailments.
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`These are just someof the extraordinary advancesthat are transforming health. But wealso face
`challenges as westrive to ensure that Americanshaveaccessto these and other opportunities.
`Both the time and the cost of medical product developmentcontinuesto rise for many types of
`products. We know that the cost of product development can impact how such products are
`priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new
`treatments and services. At the same time, FDA faces new public health challenges. Principal
`among them is the ongoingcrisis of opioid addiction. Wealso continue to face too much
`avoidable death and disease associated with smoking tobacco; and childrenarestill becoming
`initiated on, and addicted to, nicotine.
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`The work wedooverthe next few years will define how we advance many of these new and
`transformational technologies that will enable patients to benefit from platformslike gene and
`cell therapy, while addressing their novel risks and uncertainties. FDA will play an important
`role in leveraging science-based waysto improvetheefficiency and predictability of the
`developmentprocess, while advancing ourability to make sure that new products have been
`carefully evaluated for safety. When it comes to new areaslike regenerative medicine, gene
`therapy, and digital health, we will be responsible for fully establishing the contemporary
`regulatory approach for properly evaluating these products, and setting these guidelines in
`action. In somecases,it is going to require us to modernize ourtraditional approach to
`regulation to makesurethat our policies are suited to novel challenges.
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`Already, FDA’s ability to harness the full potential of these new opportunities has been enhanced
`dueto recent legislation that gives FDA additional resources and authorities to safely cultivate
`new technologies and scientific discoveries. This includes the 21st Century Cures Act (Cures
`Act), and the recently enacted FDA Reauthorization Act of 2017. Making sure we leverage these
`opportunities and advancethesecritical policy areas is a big part of our focus in 2018 as we
`continue to execute across our portfolio of high priority public health obligations, and solidify
`our fundamental role in protecting consumersfrom unsafe products and dishonest marketing.
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`Our Roadmapis not intended to be a traditional strategic plan; andit is not an exhaustivelist of
`the important policies that FDA will initiate and pursue over the coming year. In focusing on
`these selected efforts, we will optimize our resourcesto achieve clear deliverables that will yield
`results over the next two years. Publishing this Roadmapis another way that we aim to provide
`more transparency about the FDA’s policy undertakingsto all our stakeholders.
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`Weaim to secure more advantagesfor society in the form of moreefficient risk management,
`better access to safe products that extend lives, improved nutrition, broader consumerchoices,
`and a lower burdenof chronic disease in people and animals. At the same time, we will work to
`empowerpatients and providers with better information about the safety and effectiveness of
`new products, so they can tailor treatments to individual medical needs and preferences.
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`These goals — and the work wedo together in achieving them — go to the heart of our mission of
`advancing andprotecting public health, while maintaining our commitmentto the scientific
`standards that make FDA a recognized global leader, and a gold standard for product review.
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`Scott Gottlieb, MD
`Commissioner of Food and Drugs
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