FDA’s 2018 Strategic Policy Roadmap Shows Promising Future

Jan 25, 2018

FDA Commissioner Scott Gottlieb recently came out with the FDA’s 2018 Strategic Policy Roadmap, which broadly focus on four areas:

  1. Reduce the burden of addiction crises that are threatening American families
  2. Leverage innovation and competition to improve healthcare, broaden access, and advance public health goals
  3. Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease
  4. Strengthen FDA’s scientific workforce and its tools for efficient risk management

As Gottlieb carefully points out, these are not independent concepts, nor are they all-encompassing. Within these four areas, the FDA plans to address both the opportunities and challenges presented by the unbelievable innovations coming out of our industry, and to ensure consumers have the appropriate information and access to these lifesaving therapies and technologies. They’re looking at cell and gene therapies, non-addictive opioid alternatives, medical devices, digital health and more. Gottlieb’s cover letter captures the incredible potential of these innovations:

“Our work is taking place during an inflection point in both science and policy. We have more opportunity to deliver on the promises of science than at any time before. Gene- and cell-based therapies hold the opportunity to treat a wider range of debilitating disorders, and deliver outright cures to intractable diseases. New gene-based technologies enhance the 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 more actionable clinical information. More targeted medicines allow human and animal patients to realize more of the benefits of new drugs, with fewer side 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.”

These advancements, however, will mean nothing if patients do not have access. That’s where industry and payers must work together to ensure patients can benefit from the therapies being approved by the FDA – whether that’s through some innovative payment method or another partnership.

Don’t miss MassBio’s Annual Meeting, March 21-22, where these topics will be discussed by industry leaders and stakeholders. Register today: https://www.massbio.org/events/2018-massbio-annual-meeting-2487


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