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Speech | In Person

Event Title
Remarks to the Alliance for a Stronger FDA
April 10, 2019

Speech by
Anna Abram
Deputy Commissioner for Policy, Legislation, and International Affairs - Food and Drug Administration ( March 2019 - January 2021 )

(Remarks as prepared for delivery)

Thanks Ladd [Wiley], for that introduction.

What a great opportunity is to speak to such a diverse group – consumers, patients, industry, and health care groups. While you likely don’t agree on every issue, here you are united around the goal of ensuring a stronger FDA. That’s a powerful testament to FDA’s broad scope and critical purpose in American society.

Today, I can report that after almost two years under Dr. Scott Gottlieb’s extraordinary leadership, FDA is indeed a strong, responsive and nimble agency. And I can assure you we will remain so with Dr. Ned Sharpless at the helm. There will be no loss of continuity and there are no plans to shift away from our existing priorities.  The agency is committed to continuing to advance our public health protection mission and to working with Dr. Sharpless as the new Acting Commissioner.

I think we can all agree that Dr. Gottlieb set a brisk, and quite prolific, pace towards fulfilling the agency’s public health mission during his tenure. According to StatNews, his cumulative statements, press releases, speeches and other written declarations amounted to nearly 160,000 words – in only his first seven months - far more words than any previous commissioner. And that doesn’t take into account written declarations by other senior officials during this same tenure.

But there’s another significant metric that’s worth considering.  Last year, FDA posted the most Federal Register notices in its history, primarily because we issued more guidance documents than ever before. 

As those in this room know, much of FDA’s policy work, as reflected in the Federal Register, is iterative. We revise and update our previous guidance in response to changes in science and technology, new information raised by stakeholders or simply an enhanced understanding of a particular policy issue. These numbers - like the StatNews word count - reflect FDA’s commitment to transparency, communication and outreach. We know our stakeholders want guidances because they provide important clarity that ultimately makes their own work more efficient. To my way of thinking that’s a sign of regulatory certainty, flexibility, and transparency as we advance our vital public health mission.

Consider some recent examples.  In early February, we issued a draft guidance that aims to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in conducting more efficient and successful drug development programs. Another recent draft guidance outlined principles for premarket review of combination products – these are products that combine a drug, device, and/or biological product and that therefore confront potential differences in their review pathways, making them more complex to develop. The draft guidance will enhance clarity, predictability, efficiency and consistency – and make it possible to bring innovative products to market more efficiently.

Guidance isn’t the only marker of our ongoing activity. Our medical product offices have been busy as well. Last year our Center for Drug Evaluation and Research approved a record 59 novel drugs which helped a wide range of patients suffering from many different medical conditions. Nearly a third of those drugs are first-in class and often have mechanisms of action that differ from existing therapies. They include several new treatments for cancer, new treatments for migraines and influenza, the first non-opioid drug product approved to help reduce opioid withdrawal symptoms, the first monoclonal antibody to treat certain patients with HIV, and new medical countermeasures for especially challenging indications.

Meanwhile, our medical device program approved 106 novel devices in 2018, surpassing the 40-year record FDA set in 2017 of 99 novel device approvals and capping eight years of steady improvement helped by new policies, process and programs implemented over recent years to help efficiently promote safe and effective innovation in medical device development. These products included the world’s smallest heart valve for newborns and the first artificial iris.

With so much going on at FDA, one might find it hard to remember it all. Early last year FDA published a Strategic Policy Roadmap identifying four priority areas for policy activity in 2018. They include: (1) reducing the burden of addiction crises threatening American families; (2) leveraging innovation and competition to improve healthcare, broaden access, and advance public health goals; (3) empowering consumers to make better and more informed decisions about their diets and health, and to expand opportunities for using nutrition to reduce morbidity and mortality from disease; and (4) finally, strengthening FDA’s scientific workforce and its tools for efficient risk management.

These four thematic areas embody the overall scope and spirit of our collective efforts in pursuing FDA’s public health mission. All four of these priority areas will continue to be at the heart of our policy activities.

Today, I’d like to highlight a few topics in each of the four priority areas – and then conclude by talking about a few of my own initiatives.


Addressing addiction is one of FDA’s most urgent priorities.  The opioid crisis is one of the largest and most complex public health tragedies that our nation has ever faced and certainly the biggest public health crisis facing the FDA. Opioid-overdose deaths have climbed every year for the past two decades, resulting in an epidemic that saw 72,000 deaths in 2017 alone. It’s a problem so severe that overdoses from prescription opioids are actually reducing overall life expectancy in the United States.

This crisis has been uniquely challenging for FDA. We’re tasked with ensuring that a drug is of high quality and safe and effective for its intended use. But opioids are different than most classes of drugs: they are potentially subject to misuse, abuse and addiction, which raises a whole host of issues and requires FDA to consider not only the consequences of legal use of the drug, but illegal use as well.  A couple of weeks ago, former Commissioner Gottlieb, working closely with FDA’s scientific experts spoke to the importance of considering a new approval framework for new opioid or opioid-containing drugs for the same general indication – that the new drug should provide a significant advantage relative to an already approved opioid or opioid containing drug for the same general indication in terms of greater efficacy or greater safety.
We are committed to confronting this opioid crisis, which has required a multi-pronged strategy given the complexity of the problem. And so, we’re working on ways to reduce misuse and abuse of opioid drugs; advance innovation in less risky non-opioid pain drugs; support both better treatments for opioid-use disorder and expanded access to naloxone; and combat the sale and shipment of illegal drugs at our borders and on the Internet.

The bipartisan Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, often referred to as the SUPPORT Act and which was signed into law late last year, grants FDA meaningful new authorities to more forcefully address all four of those strategies.

Preventing new opioid addiction means reducing initial exposure to opioids and rationalizing prescribing, making sure that when drugs are prescribed it’s for a dose and duration that comports with the clinical circumstance. Thanks to the SUPPORT Act, FDA can require short-duration packaging for outpatient dispensing. Our research suggests that for many acute pain indications where opioids are used, a day or two of the drug is appropriate, and so FDA is considering whether to mandate that certain solid, oral dosage forms of immediate-release opioid formulations be made available in small quantities in blister packaging. We also want to combat diversion - and one way to do that is getting unused medications out of the medicine chest.  Under the SUPPORT Act, we can require manufacturers to develop disposal technologies such as mail-back pouches.

There’s also a fundamental question about exposure to opioids and it’s this: Are we approving new opioids that really offer no comparative benefit over existing drugs? Are we putting the public at greater risk? Addressing that question could require revisions to statutory authorities that would allow us to change the weight we give to the safety or effectiveness advantages of a new drug over existing therapies. As a start, we plan to issue a draft guidance document to modernize the FDA’s framework for assessing the risks and benefits of opioid drugs.

Promoting the development of drugs to treat pain that are not addictive or are abuse-deterrent is the second prong of our opioid strategy. In 2019, look for updated guidance outlining the appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain. We’ll also be exploring new methods for analyzing and evaluating abuse-deterrent features.

The third prong of our opioid strategy is aimed at those who already have opioid use disorder.  We will continue looking for ways to expand access to naloxone, the life-saving drug that can reverse an overdose. Naloxone is currently only available via prescription and can be quite expensive.  To further expand access, we’ve been helping to foster the development of an over-the-counter version of this life-saving drug, including taking the unprecedented step of developing and testing a model of a Drug Facts Label for OTC naloxone. We unveiled the results of this work in January.  We hope this will jump start development of an OTC version of this drug.

Since 2015, the estimated number of opioid prescriptions dispensed from outpatient retail pharmacies has fallen by 24%.  And prescriptions for higher strength opioids have fallen even more steeply. However, while these trends are encouraging, combatting our nation’s tragic opioid epidemic will continue to be one of the highest priorities for the agency. 

I’d be remiss if I didn’t also mention our work on tobacco when talking about FDA’s plans to reduce addition.  In July of 2017, we unveiled a comprehensive plan on tobacco and nicotine regulation aimed at reducing tobacco-related disease and death. In 2018, the National Youth Tobacco Survey data showed significant increases in youth e-cigarette use, raising public health concerns so FDA stepped in to act.  We’re committed to reversing this troubling increase of youth use of these products. On March 13, 2019, we announced a guidance aimed at preventing access and appeal of flavored e-cigarettes to youth.  We will not let the potential off ramp for currently addicted adult smokers to transition to a less harmful product become the onramp for a new generation of teens becoming addicted to nicotine. You will see more in the upcoming months as we continue to work on issuing foundational rules for the Tobacco Control Act and move forward implementing the agency’s comprehensive framework.


Another strategic policy area is aimed at increasing competition among medical products. The lack of competition can contribute to the high price of some prescription drugs and ultimately reduce access for patients in needs of these medicines.

Patients can’t benefit from new medical innovations if they can’t afford them. Although FDA does not have a direct role in drug pricing, we do have a role to play in facilitating robust and timely market competition for lower-cost generic drug products, biosimilar, and interchangeable biological products.

Generics already account for 90% of all prescriptions written, resulting in savings of more than $1 trillion over a decade and $265 billion in 2017 alone, so we’ve given considerable attention to those areas that impact competition, such as gaming by brand manufacturers that extends monopolies beyond what Congress intended, assisting development of complex generics that are hard to genericize, and incentivizing competition for sole source generics – those drugs that are available only from one generic manufacturer because the brand name drug has been withdrawn and there are no other generic competitors.

In 2018, we approved or tentatively approved more than 1,000 generic drugs with record-breaking highs in October and November, with first generics accounting for nearly 10% of approvals and complex generics accounting for about 14% of those approved.

In 2018, we also advanced several policies aimed at making it more efficient to bring generic competition to the market, starting with providing critical guidance and support to generic drug developers and streamlining the generic drug submission and review process.

In addition, we implemented the new Competitive Generic Therapy approval pathway created under the Food and Drug Reauthorization Act of 2017, which was designed to expedite the development and review of generic drugs when there is inadequate generic competition.   Numerous drugs now have the Competitive Generic Therapy designation, and so far, eight drugs have been approved with Competitive Generic Therapy exclusivity.

We’re now focused on two proposals to address anti-competitive practices by certain first applicants for generic drugs. By law, when certain criteria are met, a first applicant receives 180-day exclusivity. In our 2020 budget, we’re seeking to prevent a first applicant from parking their exclusivity indefinitely and preventing additional generic manufacturers from entering the market in certain circumstances. Under our proposal, first applicants that are eligible for 180-day exclusivity but have not obtained final approval of their generic application, would not be able to indefinitely block subsequent generics from entering the market in certain circumstances. Under the proposal, if certain conditions are met, the first applicant’s 180-day exclusivity would be triggered when, among other things, a subsequent application is ready for final approval but for the first applicant’s 180-day exclusivity.

We’re also proposing to clarify the 180-day forfeiture provision under which first applicants with a deficient application may avoid forfeiting their exclusivity even when the application is deficient for reasons other than a change in or review of FDA requirements for approval.
Biologics, which represent almost 40% of all prescription drug spending, play an outsized role in rising drug prices, accounting for 70% of the growth in drug spending from 2010 to 2015, according to a RAND study. While the U.S. market for biosimilars is still maturing, FDA research suggests that after market entry, biosimilars have the potential to offer significant savings. This is especially true after two or more biosimilars are approved and on the market. As of today, FDA has approved 18 biosimilars, but so far, only a fraction of these approved products has come to market.  Our Biosimilars Action Plan, which launched last year, is similar to what we’ve been doing with our generic drug program.  It involves improving the efficiency of the biosimilar and interchangeable product development and approval process; increasing regulatory clarity through guidance; working to educate patients, clinicians and payors about these products; and working on ways to reduce gaming of FDA requirements or other attempts to unfairly delay competition.

We plan to continue to build on this momentum in 2019 by issuing revised draft or final guidance for areas of key importance to the development of biosimilars.

Our efforts to develop and support a competitive marketplace for biological products also extends to insulin. Access to affordable insulin is a matter of life and death for the seven million people with diabetes who require daily insulin injections to maintain their blood glucose level. Unfortunately, with the average list price of insulin increasing 15% to 17% annually from 2012 through 2016, we’ve heard frequent reports of patients rationing insulin and, in some cases, dying because they can’t afford the injections. Today, there are no approved generic insulin products that can be substituted at the pharmacy, in part because it is hard to bring a substitutable insulin to market under the Federal Food, Drug, and Cosmetic Act. When Congress enacted the 2010 law creating the biosimilars path to market, it required that on March 23, 2020, biological products approved under the Federal Food, Drug, and Cosmetic Act (such as insulin products) will be deemed to be licensed under the Public Health Service Act (PHS Act), which already governs the FDA approval of most biologics. FDA has been working to facilitate that transition with guidance that describes how we plan to go about the deeming process. The transition of insulin to regulation under the Public Health Service Act means, for the first time, insulin products that are biosimilar to, or interchangeable with, an insulin reference product may be approved by FDA and come to market.  Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and lower costs for patients.

The FDA anticipates that these products, once they are approved, will bring new competition to the insulin market and help provide safe, effective and affordable treatment options to patients with diabetes.

There’s another, indirect way, that FDA can influence drug costs –it’s how we regulate medical products. We believe that when regulation is streamlined, predictable and science-based, it can help to reduce the time, uncertainty and cost of drug development while still ensuring the safety and efficacy of the products we regulate.

Price isn’t the only issue influencing a patient’s access to medicines. There are many other access issues as well, some of which we’re actively seeking to address. Take drug shortages for example. FDA currently has authority to expedite reviews of certain drug applications and supplemental applications and to expedite inspections that could help mitigate a shortage. We exercise this authority when appropriate and we’re proud of our existing progress. Last year, we successfully worked with manufacturers to prevent 160 shortages, and identified only 54 new ones, down from a peak of 251 during calendar year 2011. But issues remain. For example, we continue to grapple with shortages of the auto-epinephrine injectors, which can treat allergic reactions in an emergency situation. Last July, we formed a task force to take a comprehensive look at all drivers of drug shortages with the goal of identifying potential ways to prevent or mitigate future shortages.  To get the broadest picture possible, we asked senior leaders from CMS, the VA, DoD, FTC and the Office of the HHS Assistant Secretary for Preparedness and Response to participate in the working group as well. The group has held listening sessions with stakeholders and is expected to send a report to Congress by year’s end.

Finally, there’s one other important access issue I want to mention and that involves compounded drugs. We know that some patients require medications that can’t be met by FDA-approved drugs and that’s where pharmacy compounding can step in. But compounded drug products are not reviewed by FDA for safety, effectiveness, or quality before they are marketed. A few years ago, in the wake of the fungal meningitis outbreak associated with contaminated compounded steroid drugs, Congress enacted the Drug Quality and Security Act or DQSA, which addressed the need for improved compounding practices, more robust oversight, close federal state collaboration and a clear legal framework with tools for FDA to address unlawful compounding. Title I of DQSA enabled FDA to fully implement and enforce existing law about traditional compounders who produce medicines for an individual patient with a valid prescription and created a new compounding category for outsourcing facilities, those that may engage in larger-scale, nationwide distribution with the potential to expose more patients to risks. Under the DQSA, outsourcing facilities must meet FDA’s current good manufacturing practice requirements, be inspected by FDA according to a risk-based schedule, report adverse events and meet other conditions.

Since 2013, the compounding program has convened nine pharmacy compounding advisory committee meetings and issued more than 40 draft, revised draft, and final guidance documents; six proposed and final rules; two proposed and final federal register notices; and a draft and revised draft FDA-State Memorandum of Understanding. Last year, we advanced revised draft guidance to help make it more feasible for compounders to become outsourcing facilities.

Just last week, former Commissioner Gottlieb and I issued a statement outlining the 2019 compounding policy priorities. This year we will continue to engage with providers regarding their needs for office stock of compounded medications and evaluate additional nominations for the 503B bulks list. In addition, we plan to issue draft and final guidance documents pertaining to certain compounding activities, as well as a memorandum of understanding with states. We also intend to initiate in-depth training opportunities on good manufacturing practices for outsourcing facilities and for our own cadre of investigators.

That’s a lot of work on compounding in a short period of time. But remarkably only a few people are dedicated 100% of the time to developing compounding policy at FDA.  In fact, just ONE person has drafted nearly every guidance issued since the fungal meningitis outbreak. Let that statistic sink in. To my way of thinking, this is a great example of what our dedicated FDA staff is capable of accomplishing, and this is something we see across the agency because this is what FDA does.


A third policy priority area touches on nutrition.

Today, chronic diseases such as heart disease and cancer are the leading cause of death and disability in the United States. Almost 40 percent of U.S. adults are obese, and if you add overweight adults, the percentage goes up to a staggering 70 percent. Poor nutrition plays a role in these patterns of chronic and preventable disease. About three-fourths of the population has a diet that’s low in vegetables, fruits, dairy and healthier oils – foods that are important to good health. At the same time, most Americans exceed the recommended intake of added sugars, saturated fats and sodium.

The FDA is committed to finding new ways to reduce the burden of chronic disease through improved nutrition. Last year, we issued a Nutrition Innovation Strategy with a two-fold goal – first to reduce preventable death and disease caused by poor nutrition by ensuring that consumers have access to accurate, useful information to make healthy food choices, and second to foster the development of healthier food options. These are efforts where we truly can have a profound, generational, and transformative impact on human health, outweighing any single medical innovation or intervention we could discover.

Our work on menu labeling is one example of what we’re doing to ensure that consumers have access to information to help them make healthy food choices.

Similarly, we have made much progress implementing the new Nutrition Facts label by providing several guidance documents to help industry implement the new requirements. We have already published guidance documents on dietary fiber and on technical issues related to serving sizes, format of the label and the declaration of vitamins and minerals.  Look for a final guidance on declaring added sugars on single-ingredient packages of sugars, syrups and cranberry products to be out soon. And in 2020, we’re planning to launch a campaign to educate consumers about our new label. We see modernizing food packaging claims as another way for consumers to make healthy food choices. Public health recommendations for what is considered healthy in the diet have evolved for various nutrients, as reflected by the 2015-2020 Dietary Guidelines for Americans and the updated Nutrition Facts label, which may affect current nutrient claims. Moreover, healthy dietary patterns now focus on food groups, the type of fat rather than the total amount of fat consumed and now address added sugars in the diet. In light of these changes, we are well on our way to publishing a proposed rule to redefine the word “Healthy” on the food package.

We’re also looking at modernizing our standards of identity, that is, regulations that specify the ingredients, composition, and processing of certain foods. We want to make sure that these standards are not barriers to the development of healthy products.  We are also specifically considering the naming of plant-based beverages such as soy milk using dairy terms like milk as one such area we are studying.  As we know, the phrase “almonds don’t lactate” has taken on new meaning and sparked an entire industry of t-shirts, mugs, and hats online. We have issued a “request for information” to solicit feedback from our stakeholders before we move forward to clarify such labeling.

In addition to our work on nutrition, in 2019, we’ll also be working to bring the regulatory framework for dietary supplements into the 21st Century. The dietary supplement market has grown exponentially in both size and scope since the Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994.

As supplements have grown in popularity, so too have the number of products on the market that are potentially dangerous or that make unproven/misleading health benefit claims and/or disease claims. FDA recently established an internal Dietary Supplement Working group tasked with taking a closer look at our organizational structures, processes, procedures and practices to identify modernization opportunities. We’ve established three policy priorities—protecting consumers from unsafe products; ensuring product integrity and quality; and promoting informed decision making—and have begun taking steps to achieve these goals. And we plan to hold a public meeting on May 16 at FDA (College Park) to hear from stakeholders about other steps we might consider for advancing responsible innovation.

Another popular category of consumer products that is also overdue for modernization is cosmetics, which includes perfumes, makeup, fingernail polish, moisturizers, some shampoos, hair dyes, face and body cleansers, deodorants, tattoo inks, and shaving preparations. Cosmetics are regulated under an 80-year-old statute –provisions of the Federal Food Drug, and Cosmetic Act going back to 1938 which seek to make sure that cosmetics are safe for consumers when properly labeled and used according to directions on the label. To update the current paradigm, we would need to work with stakeholders, including Congress, to modernize the outdated regulatory framework. In the meantime, FDA has asked industry to voluntarily register and list their products.

FDA’s Scientific Workforce

Another strategic policy area is strengthening FDA’s scientific workforce and its tools for efficient risk management – or you might say, building a stronger FDA. The core technical scientific and clinical expertise of FDA is its people. As the products that the FDA is asked to review become more complex and specialized, so do the technical demands on the agency’s workforce.

Several efforts are underway to build upon the strength and expertise of the FDA’s professional workforce. This includes conducting a comprehensive evaluation of the agency’s hiring and retention practices and procedures and modernizing the process for recruiting, retaining and supporting personnel.

To improve our ability to rapidly identify and select the most talented candidates, FDA has enacted a hiring pilot testing an innovative recruitment and engagement process and what we learn will help inform our overall hiring strategy. We have implemented the new hiring and compensation authority provided under the CURES Act expanding the agency’s ability to recruit and retain qualified and outstanding scientific and technical staff to support medical product development, review, and regulation.

We’re also modernizing the organizational structure and process of the Center for Drug Evaluation and Research, Office of New Drugs to update our approach to drug review across every stage in the drug life cycle and reorganizing the Office of the Commissioner, creating a flatter structure that strengthens collaborations with the leadership of the agency’s centers and the Office of Regulatory Affairs. The new organization eliminates four “directorates” Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations, and creates two new offices – an Office of Food Policy and Response and an Office of Clinical Policy and Programs. 

In my own organization, the Office of Policy, Legislation, and International Affairs or OPLIA as I like to call it, aligns our two offices working with Congress – the Office of Legislation and the Office of Congressional Appropriations under one umbrella, allowing to enhance their already strong coordination.  The reorganization also brought into OPLIA the newly established Office of Global Policy and Strategy, a re-organized international office (formerly in the Office of Global Regulatory Operations and Policy or GO). This will be a critical step in further elevating our international endeavors and ensuring this work is fully integrated into and across the agency’s strategic engagements and key policy initiatives.

My priorities

As any good deputy will tell you, my priorities are the Commissioner’s priorities and the agency’s priorities.  I also believe that offices within the Office of the Commissioner have a responsibility to advance the work of FDA’s Centers and Office of Regulatory Affairs, so their priorities are mine as well.  That’s a lot of priorities and I’ve only touched upon a few here today so far.

So, in my last few minutes, I wanted to cover a few areas that are of particular interest to me.

First is what we’re doing to lay the groundwork for cutting-edge innovation in plant and animal biotechnology. Promising new technologies that can edit animal and plant genomes have the potential to improve human and animal health, animal well-being, food productivity and food security. New forms of biotechnology allow modification of living organisms, such as plants or animals, in order to produce a new product, such as a novel pharmaceutical, new food variety or disease resistant crop. But to advance this progress, it’s critical that the FDA adopt a science-based regulatory approach that is innovative and nimble. Like so much of what we do, that means applying a risk-based regulatory approach to provide predictability and maintain public confidence in our regulatory system. To achieve that, last October, the Commissioner and I announced our Plant and Animal Biotechnology Innovation Action plan and last week, the Commissioner and I published an FDA Voices piece on our current and planned actions. I would like to highlight a few of those actions here.

Over the past year, we have been expanding our already broad scientific expertise through targeted hiring of scientists in the Division of Animal Bioengineering and Cellular Therapies for the science- and risk-based evaluation of intentional genomic alterations in animals and animal cell, tissue, and cell- or tissue-based products. We’re also piloting a new Veterinary Innovation Program which offers intensive technical and programmatic assistance to developers of certain innovative veterinary products, including animal biotechnology products. Many developers have already come in to speak to FDA about their plans or ideas.  This early collaboration and communication is key to a transparent and efficient regulatory system.

Later this month, FDA will hold a webinar to discuss policy changes to make the FDA’s approach more flexible and risk-based. We’ll also discuss current scientific evidence and regulatory science questions important for the FDA’s decision-making for genome editing in animals. As a next step, the FDA intends to adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including intentional genomic alterations in animals, beginning with two risk-based guidance documents on the topic. FDA plays a vital role in ensuring the safety of these products and is committed to working with innovators and developers to navigate the process of bringing these products to market.

The second item is preparedness—an area that doesn’t always get as much attention as other areas of FDA’s portfolio, but represents some of the most essential work that we do. FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear and emerging infectious disease threats such as pandemic influenza and Ebola viruses. FDA is responsible for reviewing the safety and effectiveness of medical countermeasures – drugs, biologics, vaccines and devices to counter these threats. Last year, we approved the first blood test to evaluate mild traumatic brain injury under the Breakthrough Devices program; a drug to treat patients should smallpox, a contagious and sometimes fatal infectious disease, be used as a bioweapon; an autoinjector to treat chemical nerve agent poisoning; a new indication for a drug that increases survival of adult and pediatric patients who are exposed to myelosuppressive doses of radiation, among other products. And we established a framework for enhanced collaboration with the Department of Defense which authorized DoD to request and FDA to provide assistance to expedite development and FDA review of products needed to diagnose, treat or prevent serious or life-threatening diseases or conditions facing American military personnel.

Yesterday, Rear Admiral Denise Hinton and I published an FDA Voices piece on medical countermeasures.  The piece highlights how we along with our regulatory responsibilities, and response to specific outbreaks, like the ongoing Ebola outbreak, also closely collaborate with the Department of Health and Human Services, other federal agencies, and international partners, like the World Health Organization and international regulatory counterparts, to build and sustain the medical countermeasure programs necessary to prepare for and respond effectively to public health emergencies. FDA offers critical scientific and regulatory expertise through these collaborations.  These engagements are key because emerging infectious diseases know no geographical boundaries.

Third is international affairs.  As I mentioned earlier, the new Office of Global Policy and Strategy is now part of the OPLIA structure that I lead. The importance of our global policy and strategy has never been greater as we face an increasingly global scope to our public health mission.  Global production of FDA-regulated goods has become an everyday reality. Other countries now supply about 32 percent of the fresh vegetables, 55 percent of the fresh fruit and 94 percent of the seafood that Americans enjoy. In addition, 35 percent of medical devices are imported to this country.  Today, with 300,000 foreign facilities in more than 150 countries exporting FDA-regulated products to the United States, FDA works beyond U.S. borders to ensure that products coming into the United States are safe and effective. We maintain foreign offices in Belgium, Chile, China, Costa Rica, India and Mexico, and have embedded a staff person into the European Medicines Agency. They not only support inspections but provide local companies with hands-on training and real-time feedback on how to meet FDA’s regulatory requirements, advise foreign regulatory authorities on how to build their regulatory capacities and closely monitor and report on conditions, trends, and events that could affect the safety, quality, and effectiveness of FDA-regulated imports.

I am looking forward to delving more deeply into the international work at FDA.  Our regulatory framework must be modern and efficient while protecting the American public regardless of if the product is produced domestically or internationally.


Today’s tour through our strategic roadmap and my priorities was necessarily limited. But I hope that you’ve seen how our focus never waivers from what is best for public health because that is the bedrock of our science-based mission. It has and will continue to be our guiding light. Dr. Sharpless is deeply committed to the public health.  Dr. Sharpless comes to FDA with experience as a clinician, a researcher, and most recently as the Director of the National Cancer Institute at the National Institutes of Health.  His dedication to patient care and advancing treatment and science has prepared him well for his role at FDA and he is supported by thousands of dedicated professionals at FDA who share an unwavering commitment to our critical consumer protection mission. I am truly humbled to work with such an amazing and talented group of colleagues at FDA.

When Secretary Azar visited FDA last week, he echoed FDA’s priorities.  And these priorities are my priorities.  As out

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