Fall 2018 Unified Agenda: FDA's New Regulatory Work to Advance Health and Safety

October 17, 2018

By: Scott Gottlieb, M.D.

FDA Commissioner Scott Gottlieb, M.D.

Today, the federal government 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 U.S. Food and Drug Administration (FDA), the Agenda reflects our 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, we 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:

Reducing the burden of addiction crises that are threatening American families;
Leveraging innovation and competition to improve health care, broaden access, and advance public health goals;
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,
Strengthening FDA’s scientific workforce and its tools for efficient risk management.

The Fall 2018 Unified Agenda reflects our continued commitment to these priorities as well as other new steps to enable us to advance these and some additional goals.

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. We’ll continue to consider a product standard to lower nicotine in combustible cigarettes to minimally or non-addictive levels, and we’re proposing additional meaningful actions to advance our comprehensive approach to nicotine, combustible cigarettes and electronic nicotine delivery systems.

This Unified Agenda includes our efforts related to establishing standards for characterizing flavors in tobacco products; requirements for tobacco product manufacturing practices; implementing product standards for testing battery safety and battery management systems of e-cigarettes; creating registration and product listings for tobacco products; and, administrative detention of tobacco products. We’re also continuing to press forward with aggressive steps to address the epidemic of e-cigarette use among youth, through our 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 percent of U.S. adults are obese, and if you add overweight adults, the percentage goes up to a staggering 70 percent. 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, we announced the FDA Nutrition Innovation Strategy, which takes a fresh look at approaches to reduce preventable disease and death related to poor nutrition.

Our 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, we’re 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.

In addition, we’re also advancing rulemaking to revoke outdated standards of identity, including standards of identity in French salad dressing and frozen cherry pie. This is a down payment on a comprehensive effort to modernize food standards to reduce regulatory burden and remove old-fashioned barriers to innovation. To support this effort, we’ll also reopen the comment period on a proposed rule seeking to establish general principles to update the framework for standards of identity. In addition to standards of identity, there are statutory and regulatory provisions that relate to the naming of food products.

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. We’re 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.

One rulemaking will improve the delivery of mammography services and allow for more informed decision-making by strengthening the communication of breast density information. We also have rulemakings 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 us to explore ways to modernize our regulatory approach 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 we actively regulate, and those that don’t fall under our purview.

We’re 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. Our commitment to safety is also reflected in rulemakings on the classification of wound dressings including antimicrobials or other drugs or chemicals.

We’re also planning to issue a final ban on electrical stimulation devices used for self-injurious and aggressive behaviors. We believe these products present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling. The FDA takes the act of banning a device only on rare occasions when it is necessary to protect public health.

Advancing Drug Safety, Accessibility and Affordability

We’ve included several drug-related regulations on the Fall Unified Agenda in support of our 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. We’ll also continue our efforts to ensure the safety and effectiveness of sunscreen drug products for over-the-counter use.

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. We have 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.

This year we believe we’re on pace to have another very strong year.

Newly approved products treat a wide range of patients suffering from many different medical conditions—from rare disorders to common diseases. These new treatments are offering new hope for improved quality of life, and in some cases, improved chances of surviving life-threatening illnesses.

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 we do.

Over the next year, we’ll continue our 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. It’s important to note that just because a previously identified regulation doesn’t appear on the Fall 2018 Unified Agenda submission doesn’t mean that work doesn’t continue on these other priorities. Or that the Agency doesn’t consider them a key area of focus.

The Fall 2018 Unified Agenda represents just some of the many efforts we have underway, as we continue to advance policies that promote the health of patients and animals and help protect consumers.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Follow Commissioner Gottlieb on Twitter @SGottliebFDA