Oct 24, 2017, 5:49 PM ETConference Presentation, Fireside Chat, Panel

A Conversation with FDA Commissioner Scott Gottlieb

Sleep deprivation is identified as a major driver of obesity in the U.S. population, with sleep hours decreasing over the past two to three decades.
Epidemiological data links inadequate sleep to increased hunger hormones, higher calorie intake, weight gain, and obesity.
The problem is exacerbated in children due to the presence of cell phones and televisions in bedrooms.
Community factors, such as long commutes (specifically noted in the Washington D.C. area) and the demands on working/single parents, create barriers to preparing healthy meals.
Screen time disparities are highlighted, with lower-income children spending significantly more time on screens than higher-income peers.

There is a call for increased investment in research regarding children's interaction with technology, specifically questioning what additional evidence is needed beyond existing data on screens.
Panelists suggest promoting "efficient parenting" around screen time, noting that current messaging (e.g., the American Academy of Pediatrics' two-hour limit) is often unclear to parents.
The Milken Institute, Robert Wood Johnson Foundation, and "Wellville" (associated with Esther Dyson) are cited as existing partners in strengthening family wellness.
A key sentiment expressed is that while the "what" of solutions is known, the "how" to scale effective interventions across rural, urban, and low-income communities remains a major challenge.

The FDA aims to reduce new addictions by limiting overall exposure, recommending shorter prescription durations (e.g., eliminating 30-day prescriptions for tooth extractions).
Packaging strategies are being adjusted to encourage 2, 4, or 6-day packs to reduce excess drugs in homes available for diversion.
Risk management plans and educational requirements have been expanded from 10% to all immediate-release opioid formulations.
Opana ER was recommended for withdrawal from the market three months prior to the summit due to illicit risks and unique diversion patterns associated with injection.
The FDA is tripling its inspector footprint in International Mail Facilities (IMFs) and quadrupling package inspections to combat fentanyl and heroin imports via mail.
Collaboration with Customs and Border Protection (CBP) and the U.S. Postal Service is intensifying to track illicit drugs on the dark web.

The FDA is implementing a comprehensive plan to regulate nicotine content in combustible cigarettes to render them minimally addictive.
Application deadlines for non-combustible nicotine delivery systems (e-cigarettes) have been extended to allow for product innovation while maintaining restrictions on access for minors.
Future regulations for e-cigarettes will specifically address appealing features, such as flavors, and marketing tactics that target youth.
A third leg of the strategy involves creating pathways for innovation in medicinal nicotine forms (e.g., patches, gums) to provide alternatives for adults seeking nicotine without combustible tobacco.

Puerto Rico: The hurricane disrupted a critical medical manufacturing hub where 10% of all drugs consumed in the U.S. are produced, including 30% of the island's GDP.
- Manufacturing facilities are operating on generators at 20–70% capacity, posing a risk of product shortages by Q1 2018 if power is not restored.
- Medical device manufacturers (employing ~18,000 people) have demonstrated corporate citizenship by providing generators, food, and housing aid to employees and local communities.
Digital Health and AI: The agency is developing regulatory frameworks for novel technologies like AI-driven diagnostic tools (e.g., melanoma detection apps) and cell-based regenerative medicine.
- The FDA is exploring "firm-based" approaches for low-risk digital health tools to streamline oversight.
- There is an emphasis on using post-market data to verify effectiveness, particularly for unmet medical needs, while maintaining safety assurances.

FDA Commissioner Dr. Scott Gottlieb highlighted the historical context of the FDA, including the 1961 National Congress on Quackery which targeted devices making unfounded medical claims.
The FDA regulates a vast portfolio ranging from food and drugs to veterinary products, tobacco, and unique issues like salmonella transmission from baby turtles.
A structural challenge noted is the time lag between research discovery and the ability to scale solutions, requiring a shift toward "scaling research" to speed up interventions.
The "Tips" campaign for smoking cessation is cited as a highly cost-effective model that has helped half a million people quit, underscoring the need for similar scalable funding for obesity and diabetes campaigns.