- Speech by
Remarks by Anna Abram
Deputy Commissioner for Policy, Planning, Legislation and Analysis
Food and Drug Law Institute (FDLI) 2018 Annual Conference
(Remarks as prepared for delivery)
Good afternoon. I’m honored to be speaking today alongside the Commissioner and many of my FDA colleagues to share some insights and updates on the vital work we are doing together under Commissioner Gottlieb’s strong leadership.
As many of you know, I joined FDA last March. Dr. Gottlieb had told me that FDA was a very special place and he was right. It’s a privilege to serve alongside FDA’s talented and dedicated staff and I am grateful for the opportunity to work with my colleagues in advancing the Agency’s vital mission.
While FDA regulates products that account for nearly 20 percent of the economy, its work touches all of our lives. I’m proud to work at a place whose mission is to help keep our citizens safe and healthy, and in doing so, improve the quality of their lives. FDA helps ensure that our food supply is safe and wholesome; that medicine and medical devices are safe and effective; and that we have the medical countermeasures necessary to protect us from a range of threats, including protecting the men and women who serve our country on distant battlefields. FDA also has important responsibilities for balancing innovation and competition through the timely and efficient reviews of generic and biosimilar applications, which can help consumers have access to more affordable medicines, after the statutory exclusivities granted by Congress have lapsed.
I’m humbled by the trust placed in me and the responsibility I have in my role as the Deputy Commissioner for Policy, Planning, Legislation, and Analysis to help the Agency meet our vital public health mission—a mission that touches so many lives in so many critical ways every day. This is ultimately a time of assessing how we can better serve the American people in all that we do. And there is no better time to seize this opportunity, given the surge in advances in science and medicine that will help us better understand and respond to the public health challenges we face now and in the future.
Today, I’d like to talk about one specific aspect of our work: ensuring that FDA’s processes are as modern, efficient, and risk-based as possible across the Agency, and how we’re applying this that approach to federal, state, and international collaborations to advance medical product and food safety, and better support our Nation’s military personnel on the battlefield.
Keeping Pace with Innovation While Advancing Our Mission
Regulatory reform is an important objective for the Administration. FDA has developed processes and procedures for identifying regulations for reform that are consistent with Executive Order 13777, where we can find ways to “alleviate unnecessary regulatory burdens placed on the American people” consistent with our public health mission. This is a question about how we develop modern and efficient regulations, and revise our existing regulations, to protect and promote public health consistent with our statutory requirements.
If we’re not being modern and efficient regulators, we’re not only adding unnecessary burdens on the public, we’re making it harder for FDA staff to effectively and efficiently perform their duties, which ultimately impacts the consumers, patients, and regulated entities depending on us.
I know that some people may fear that streamlining regulations and modernizing our processes can only come at the expense of FDA’s gold standard, but our science-based, public health mission is the foundation for all that we do, including our regulatory reform work. In fact, we see this work as an opportunity to enhance how we fulfill our mission on behalf of the consumers and patients we serve as FDA seeks to be modern and efficient in protecting and promoting public health.
Modern, risk-based regulations can enable the Agency to better focus on the core information that we need to make efficient, informed regulatory decisions in as timely a manner as possible while meeting FDA’s scientific “gold standard” for assessing product safety and efficacy. An efficient and predictable regulatory environment also allows firms to make the high-cost, high-risk investments needed to translate cutting-edge science into truly innovative products and technologies that benefit patients and consumers.
And appropriate risk and science-based flexibility – especially for emerging products that don’t fit neatly into existing regulatory paradigms – can enable innovation by developing new approaches for facilitating the development of medical products.
Regulatory certainty is key for advancing innovations that will benefit patients and consumers. In other words, we’re finding ways to streamline our regulatory approach and adopting flexible regulatory decision making while also advancing and strengthening our commitment to patient and consumer protection. We’re doing that by encouraging the use of innovative clinical trial designs that can make clinical development programs more efficient and more accessible to patients with rare diseases. We’re also working to increase the use of real world data in regulatory decision making, for example, to help us more quickly home in on important postmarket safety and efficacy signals.
FDA has played a vital role in protecting and promoting public health for more than a century. Over time, the scope and charge of the Agency’s work has dramatically changed, and grown to include many products that Americans rely on every day. Our responsibilities have an increasingly complex and growing global footprint, and our work to fulfill our mission must be done in a manner that reflects these modern challenges and opportunities.
The very size and scope of our regulatory portfolio means that sometimes we must pause and reflect on regulatory processes that have been in place for decades. Today, FDA’s regulations comprise more than 4,000 pages in the Code of Federal Regulations. Some regulations may not adequately reflect advances in science, technology or changes in industry practice. Others may be geared toward products and practices that have largely ceased to exist.
Regulatory Reform from the Ground Up
As in everything we do at FDA, we’re approaching regulatory reform in a thoughtful and measured way. In these efforts, science is FDA’s North Star in our work to fulfill our public health mission. And we have a lot of ground to cover.
The FDA’s Centers and Offices have primary responsibility for administering our regulations, and so they are leading regulatory reform implementation. We’ve created uniform approaches to ensure that regulatory reviews are consistent, include critical information to support decision making, and that our regulatory reform proposals are, of course, compliant with applicable statutes.
We know that FDA doesn’t have a monopoly on good ideas. We want to hear from stakeholders, scientific experts, and patient groups to help us identify promising areas for change and inform our endeavors. Last September, we published a set of seven Requests for Information (or RFIs) in the Federal Register, soliciting public comments to help us identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with federal law, to achieve a meaningful burden reduction without compromising our public health mission.
FDA received almost 240 comments to the seven regulatory reform RFI public dockets. Agency subject matter experts are carefully reviewing and analyzing every comment. Those comments will be considered in our ongoing regulatory reviews and implementation.
I would like to mention three examples that underscore the Agency’s efforts to have candid dialogue about what is working well, as well as opportunities to make improvements, so that we are adjusting our approaches, when necessary, to better meet our public health mission.
Last September, FDA proposed extending the compliance dates for certain provisions of a rule we issued regarding produce safety. We did so after hearing significant concerns from our industry partners, especially small businesses and farms, regarding the burden of compliance around the agricultural water testing provisions of the rule. We also proposed to simplify the compliance timetable to alleviate confusion about the rule. This delay allowed FDA to participate in a two-day stakeholder summit to learn what additional clarity we can provide to make the standards easier to understand and follow, and how we could reduce regulatory burden and increase flexibility in achieving our goal of ensuring safe fruits and vegetables for American consumers.
Last October, FDA proposed extending the compliance date for a rule that had revised and updated the Nutrition Facts Label on packaged foods, or the “other NFL” as we like to call it. This delay has allowed FDA to issue several guidances, including ones related to serving size and added sugars, and other key issues related to the implementation of the NFL rule and addressing technical concerns raised by food manufacturers.
Extending the compliance date also helps regulated industry ensure alignment with federal regulations from other agencies requiring label updates, such as those from the U.S. Department of Agriculture on bioengineered foods. Coordinating labeling compliance dates will reduce undue costs on firms, by allowing them to update their labels and graphics once, rather than piecemeal. I am pleased to announce that FDA issued a final rule this morning extending the NFL compliance date. We look forward to using this time to continue learning what additional support we can provide to aid our stakeholders in complying with the final rule.
FDA is also amending general biologics regulations relating to time of inspection requirements and removing duties of inspector requirements. We’re taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments. This will allow us greater flexibility when facilities have a strong track record of compliance, without diminishing public health protections. It also allows us to focus our resources on facilities that may pose a greater public health risk.
In addition, FDA is looking to create meaningful change wherever we can consistent with our public health mission. In the comprehensive regulation review we announced last year, we shared that we are seeking to identify all instances where our regulations are outdated and do not reflect current practice. We must be as modern as the products we are expected to regulate now and in the future, and our processes must reflect and apply modern science.
One important example of this is in our risk-based regulation of biotechnology. In light of recent advances in biotechnology, most notably the ability to edit the genome of plants and animals via CRISPR and other techniques, FDA is laying the groundwork to both support innovation and help ensure the safety of food and animal products. Our strategy is multi-pronged, ranging from providing regulatory clarity to industry, conducting consumer education and outreach, to engaging with our federal partners and other international regulatory agencies.
FDA has developed a flexible, risk-based approach to oversight of food and animal products of biotechnology, based on sound scientific evidence. FDA issued two documents for public comment in January 2017 to share the Agency’s current thinking on how our authorities apply to products of these technologies, and to receive feedback on that thinking so FDA may modify our approach based on evolving scientific evidence. We are carefully considering public input as well as reviewing current science as we determine our next steps.
Collaborative Initiatives with Our Public and Private Sector Partners
I spoke a few moments ago about our partnerships and collaborations. We’re aware that overlapping or conflicting federal, international, or state regulations create the potential for added expense and confusion about applicable standards and regulatory expectations. When it comes to food, FDA and the USDA both have obligations, and we are working closely together to avoid putting unnecessary burdens on producers and others directly affected by the implementation of our laws, including the FDA Food Safety Modernization Act, or FSMA. Commissioner Gottlieb and Secretary Perdue are building on current partnerships in many key areas and have identified others where we can strengthen collaborations to ensure an efficient, predictable, and potentially lower-cost regulatory environment for industry, while still meeting our mutual requirements and obligations.
In January, FDA and USDA formalized our ongoing efforts to enhance our collaborations through a formal agreement. We recognize that there are opportunities to better serve the American people in our respective roles by working together, enhancing how we coordinate and collaborate. For instance, the formal agreement spells out how we might reduce the number of establishments subject to the dual regulatory requirements of the USDA and FDA. This can occur when, for isntance, a canned soup facility, which produces both chicken noodle soup and tomato soup, is subject to regulation by both agencies.
Our agreement commits both agencies to identify ways to streamline regulation and reduce inspection inefficiencies, while upholding safety standards for dual-jurisdiction facilities. This will allow us to redirect resources to better target areas of increased risk. The agreement also commits the USDA and FDA to better align and enhance our efforts to develop regulatory approaches to biotechnology, as each agency works to fulfill commitments outlined in the September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products and the more recent Task Force on Agriculture and Rural Prosperity Report. As we engage with USDA in these important areas, we look forward to having more to share on our collaborations.
Looking abroad, we see additional opportunity to support risk based regulations through Mutual Recognition Agreements (or MRAs) with trusted partners like the European Union. Under the Food and Drug Administration Safety and Innovation Act, enacted in 2012, FDA has the authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if FDA determines those authorities are capable of conducting inspections that meet U.S. requirements This can allow drug inspectors to rely upon information from drug inspections conducted within each other’s borders, and FDA and the EU have collaborated since May 2014 to evaluate our inspection regimes and assess the risk and benefits of mutual recognition of drug inspections.
MRA’s can improve the efficiency of regulatory efforts by avoiding duplicative inspections, allowing the Agency to reallocate resources towards inspecting manufacturing facilities in other regions across the globe where regulatory standards may not yet be as advanced, and may present greater health risks.
Of course, we don’t need to look abroad to find strong partners for patient safety. One of America’s great strengths is our federal system, and we’re partnering with state agencies in many areas, like drug compounding. We are working hard to implement the Drug Quality and Security Act or DQSA, which sets forth a risk-based framework to meet patients’ needs for compounded drugs by traditional pharmacy compounders and outsourcing facilities when these needs are not being met by FDA-approved drugs. Oversight remains essential, because compounded drugs, while important to patients who need them, pose ongoing and serious risks.
Every year FDA receives adverse event reports linking patient illnesses and deaths to compounded drugs. These harms may be caused by contamination in drugs that need to be sterile because they are entering the bloodstream, the eye, or the spine. They may also be due to drugs that are super potent.
As we develop our policy and oversight program, FDA strives to strike a balance between preserving access to vital compounded drugs for patients who have a medical need for them, while protecting patients from the risks associated with compounded drugs that are not made in accordance with applicable quality standards or other requirements. Both FDA and the states have limited resources, so it is important we use them wisely.
With our unique expertise and tools, FDA would like to work with the states in overseeing these compounding operations.
FDA is also pursuing a number of initiatives to help the outsourcing facility sector, established by Congress under the DQSA, fulfill its intended function to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other health care providers. As many in this room know, in the four years since the passage of the DQSA, the outsourcing facility sector is maturing. The sector has grown to a size of approximately 75 registrants, and many of them are still adjusting to the applicable quality standards, as well as working through regulatory complexities, such as obtaining state licensure. I hope that you will help our state partners collaborate with us in this vital endeavor going forward.
Supporting Our Warfighters through Medical Countermeasures
Over the years, I’ve had the privilege of working on many FDA issues of great import. FDA plays an important role in our Nation’s medical and public health preparedness and response. The Agency’s responsibility to protect and promote public health extends to all Americans – but we recognize a special responsibility to help our military service personnel and advance our medical countermeasure programs to support national security.
Medical countermeasures are an integral component of our preparedness framework, but these products can face unique development challenges. It’s important for patients to have the safe and effective medical products they need when they need them. This includes our men and women on the frontline, who can face increasingly austere environments, and need to be as prepared as possible in the event of serious, life-threatening injuries.
Medical countermeasures can face inherent development challenges from the nature of the range of threat agents they are intended to combat, and there are unique considerations when it comes to battlefield medicine. But the need for these products is urgent, and it is an area of our work that we are prioritizing. We have increased our interagency coordination with the Department of Defense to further support the medical needs of service members, especially those in harm’s way.
Earlier this year, we launched a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel. This is a top priority for the Agency, and, building on existing relationships between the Department of Defense and FDA, we’re developing a collaborative program with the DoD to identify and address key medical countermeasure priorities, with the goal of ensuring these products can be developed and made available to our troops as efficiently and quickly as possible.
The framework for this program was put in place through legislation, which authorized DoD to request, and FDA to provide, assistance to expedite development and FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. Utilizing this law’s expanded authorities, FDA is working closely with DoD to better understand the military’s evolving medical needs for their personnel; as well as giving the highest level of attention to, and expediting its review of, priority DoD medical products in a manner similar to products under FDA’s breakthrough therapy designation program.
FDA and DoD leadership have committed to be actively engaged in these endeavors and collaborations. In addition, we’re looking forward to holding a joint workshop to discuss aspects of the scientific and clinical development of products that are important to the health of military personnel. Findings from this workshop will help commercial product developers identify opportunities to fulfill unmet medical needs for battlefield settings and other front-line conditions experienced by the men and women of the U.S. armed forces.
This enhanced collaboration will enable the Agency to gain a better understanding of the health needs of those protecting our country, while expediting the development and ensuring the safety and effectiveness of medical products made available to our service members. The innovations we advance in this space hold the potential not only to help us be better prepared to protect our citizens and military service personnel against a range of threats, but also to benefit American patients in a wide range of other settings and areas of medicine.
Streamlined, Risk-Based Regulation Enhances our Public Health Mission
Our focus on efficiency is already bearing fruit. Last year, we approved a record number of novel drugs, biologics, and generics; including the first two biosimilars approved for cancer as well as the first gene therapy approvals in the U.S. We also approved four times the number of novel medical devices we did in 2009.
We’ve also been focusing on actions under the Digital Health Innovation Action Plan, which FDA announced last summer. The Plan outlines the Agency’s efforts to reimagine our approach to ensuring that all Americans have timely access to high-quality, safe, and effective digital health products. Under the Plan, FDA has taken steps to identify a streamlined regulatory pathway for digital health platforms, as well as clarify what technologies do and do not fall under FDA regulation.
As we review new applications of science and technology, we’re also using them to enhance our own consumer protection role and tamp down deceptive marketing. For example, last fall we launched a new searchable database to better inform patients and health care professionals of adverse events reported to FDA for drug and biologic products.
We also took new steps to warn companies making false claims that their unapproved products can treat or cure life-threatening diseases; took steps to alert the public to the dangers of other unproven and untested products.
I’d like to take my last few minutes to talk about our efforts to reduce addiction and death from combustible tobacco, which are a core part of the Agency’s public health mission and another area in which we are actively engaged. As previewed in our comprehensive plan on tobacco and nicotine regulation announced last summer, we recently issued an advance notice of proposed rulemaking (or ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels.
This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country. This is a deeply pragmatic, risk-based regulatory effort. We know that even decades after the Surgeon General’s landmark report on smoking, combustible cigarettes remain the leading cause of preventable morbidity and mortality in the U.S., killing almost half a million Americans every year, and adding $300 billion in direct and indirect health care costs.
If we’re serious about maximizing the public health benefits of FDA’s public health work, we must focus our regulatory activities related to tobacco on the death and disease caused by addiction to combustible cigarettes, not nicotine per se, which, while not entirely benign, isn’t the root cause of the mortality and morbidity associated with smoking cigarettes.
Through the ANPRM, we’re looking to the public and stakeholders to help us consider a nicotine product standard through comments on key areas and opportunities for additional research. For instance, what potential maximum nicotine level would be appropriate for the protection of public health? Should a product standard be implemented all at once or gradually? What unintended consequences – such as the potential for illicit trade, or for addicted smokers to compensate for lower nicotine by smoking more – might occur as a result?
We want our tobacco policies to reflect the latest science, and be informed by input we receive from our meetings with stakeholders and comments to the open public docket, now and in the future.
Other countries around the world look to FDA for leadership on critical public health issues. It is part of our goal to be modern and efficient in all that we do across the spectrum of our public health mission. By doing so, we will help ensure that the U.S. remains the world’s most attractive place to research, develop, and bring forward new, safe and effective innovations, so that consumers and patients may benefit from them in as timely a manner as possible.
Before I conclude my remarks, I want to take a moment to thank everyone at FDLI that worked so hard to pull together this conference, as well as countless other events throughout the year; in doing so, you help to foster and spur dialogue around important public health issues that impact the lives of so many of our fellow citizens. Thank you for your commitment to advancing public health and this important discourse. And to our public health partners, thank you for your collaboration. And, finally, thank you to my FDA colleagues here today. Your tireless dedication to our mission is inspiring and I am honored to serve with you in these critical pursuits.
It truly is an exciting and inspiring time to serve at the Agency, especially with the talents, energy, and leadership of Commissioner Gottlieb. As he often notes, we are in the midst of an exciting time in medicine and science. I am proud of what the Agency has accomplished for patients and consumers over the past year and, as I look ahead, I am excited by the potential opportunities. This is a transformational time for medicine and public health, which offers enormous opportunities to modernize and better serve the American people in all that we do as we fulfill our mission to protect and promote public health.