October 22, 2018Regulatory
The following was excerpted from a presentation from FDA Commissioner Scott Gottlieb, M.D.
The FDA has published the Fall 2018 Unified Agenda, which provides federal agencies the opportunity to share the government's top regulatory priorities with the American public. For the FDA, the Agenda reflects its ongoing commitment to protecting and promoting the public health through science-based decision-making that informs new regulations that advance the public health and promote innovative, efficient oversight of our key areas of influence.
At the beginning of the year, FDA unveiled FDA's 2018 Strategic Policy Roadmap. This plan was the product of a close collaboration among the Agency's centers. Our Strategic Roadmap encompasses four key priorities the Agency is pursuing to advance our public health mission:
1. Reducing the burden of addiction crises that are threatening American families;
2. Leveraging innovation and competition to improve health care, broaden access, and advance public health goals;
3. Empowering 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; and,
4. Strengthening FDA's scientific workforce and its tools for efficient risk management.
Combatting Nicotine Addiction and Preventing Use among Youth
FDA's comprehensive plan for tobacco and nicotine regulation places nicotine addiction at the center of the agency's tobacco regulation efforts. This plan reflects a multi-year approach to better protect youth and help addicted adult smokers quit, significantly reducing tobacco-related disease and death in the U.S. FDA will continue to consider a product standard to lower nicotine in combustible cigarettes to minimally or non-addictive levels, and is proposing additional meaningful actions to advance a comprehensive approach to nicotine, combustible cigarettes and electronic nicotine delivery systems. Through the Youth Tobacco Prevention Plan. This comprehensive plan aims to stop youth use of, and access to, tobacco products - especially e-cigarettes. Significant regulatory and research efforts related to access, marketing are already underway and new steps are forthcoming.
Modernizing Nutrition Claims, Labels and Standards of Identity
Today, chronic diseases such as heart disease and cancer are the leading cause of death and disability in the United States. Nearly 1 in 3 adults in the U.S. have high blood pressure, a leading cause of heart disease and strokes. Almost 40% of U.S. adults are obese, and if you add overweight adults, the percentage goes up to a staggering 70%. Among children and adolescents, almost one in five are obese. Poor nutrition plays a role in these patterns of chronic and preventable disease. The FDA is committed to finding new ways to reduce the burden of chronic disease through improved nutrition.
On March 29, 2018, FDA announced the FDA Nutrition Innovation Strategy, which takes a fresh look at approaches to reduce preventable disease and death related to poor nutrition. The Fall 2018 Unified Agenda includes key actions that will improve labeling and nutrition. We believe it's important to maintain the basic nature and nutritional integrity of products while allowing industry flexibility for innovation to produce more healthful foods. Specifically, FDA is following up our earlier actions on partially hydrogenated oils in foods with a rulemaking that proposes to remove the remaining uses to further reduce deaths from coronary heart disease. We're also working on updating the definition of the claim "healthy" on food labels so it reflects current nutrition guidelines and to encourage its use.
Prioritizing Medical Device Innovation and Safety
Timely patient access to high quality, safe and effective medical devices requires that FDA reduce or reform outdated, unnecessary burdens in our regulatory approaches. FDA is focused on outdated provisions that can add to development costs or forestall beneficial innovation without also enhancing device safety and effectiveness. The Unified Agenda includes new efforts that encourage innovation through more efficient regulation, and keep doctors and patients better informed. Rule-makings are underway to ensure the medical device premarket review programs are risk-based and recognize the least burdensome pathway to market. The aim here is to more efficiently and effectively bring innovative products to market that may save lives or reduce health risks.
Digital health devices have the potential to improve our ability to accurately diagnose and treat disease, and to enhance the delivery of health care. These opportunities require FDA to explore ways to modernize regulatory approaches to better advance safe and effective innovation in this rapidly evolving area. This includes exploring the amending and/or repealing of existing medical device software regulations to create brighter lines between products FDA actively regulates, and those that don't fall under our purview.
FDA is also taking steps to remove outdated regulations or advance new rules to promote efficient patient access to innovative products. These steps include efforts to establish implementing regulations for a new category of over-the-counter hearing aids and the requirements that apply to them; harmonizing and modernizing the regulation of medical device quality systems; and, amendments to reduce records and reports for radiation emitting electronic products. This commitment to safety is also reflected in rulemakings on the classification of wound dressings including antimicrobials or other drugs or chemicals.
Advancing Drug Safety, Accessibility and Affordability
FDA has included several drug-related regulations on the Fall Unified Agenda in support of a continued effort to advance new policies that promote beneficial innovation, modernize our programs, and advance opportunities for developing more effective, targeted therapies aimed at unmet medical needs. Among these new steps are a rulemaking to broaden the kinds of drugs that can be made available without a prescription and three rules on biological products.
Thus far this year, the FDA has approved 45 novel drugs and biologics, close to our total of 46 in 2017, which was the most approved in more than 20 years. FDA also has record-setting numbers for the total amount of generic approvals in a fiscal year, with 971 total approval actions, including 781 final approvals, and 190 tentative approvals. These totals include 95-first time generic approvals.
There's More Work to be Done
The more than 70 actions we've identified in the Fall 2018 Unified Agenda represent the FDA's significant and continued commitment to delivering on our mission of protecting and promoting the public health. But they're only a portion of the work they do. Over the next year, FDA will continue its efforts to combat the opioid addiction crisis, modernize product development through novel clinical trials, use of real world evidence, advancing antimicrobial development, and increasing our work with patients.