Keynote Address to the 2018 FDLI Annual Conference May 3, 2018

Speech | In Person

• Speech by: Scott Gottlieb, M.D.

Speech by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Keynote Address at the 2018 Food and Drug Law Institute Annual Conference
Washington, DC

Good morning and thank you for having me here today to speak on behalf of the entire FDA.

Each year at FDLI the FDA Commissioner gives a state of the union, if you will, reflecting on the past year at the agency.

But today, I want to look ahead, and give you an outline of where our focus will be over the coming year when it comes to each of the spheres where we operate.

Before I delve into each of our product areas, I want to say a few words about some of the larger issues we’re focused on.

Our most pressing challenge is the epidemics of addiction facing this nation, principally to opioid drugs.

This is the biggest crisis facing the nation and FDA.

We’ll be advancing new steps to rationalize prescribing, as a way to reduce overall exposure to opioids and, therefore, the rate of new addiction. We’ll also take new steps to provide additional safeguards to how opioids are dispensed.

And we’ll have much more to say soon on some of the new steps we plan to take to address this crisis.

We’ve also been grappling with the issue of drug costs.

We want to do our part to make sure that competition works to improve access and support the market based pricing that underwrites the high cost of new, lifesaving innovations.

The American biopharmaceutical sector is one of the nation’s great achievements. It’s the product of years of investment in science and research. And we’re committed to maintain the U.S. position as the best place to invest, develop, and commercialize innovative medicines.

But for our system to continue to work, innovation has to be balanced with competition and access.

Let’s face it. Right now, we don’t have a truly free market when it comes to drug pricing, and in too many cases, that’s driving prices to unaffordable levels for some patients.

There’s a range of reasons why drug prices are too high.

President Trump and Secretary Azar will have more on this topic soon, laying out the problems we’ll solve and how we’ll aim to tackle them. Some of these problems are intuitive and straightforward; others are complex and challenging

To take one example, one of the dynamics I’ve talked about before that’s driving higher and higher list prices, is the system of rebates between payers and manufacturers.

And so what if we took on this system directly, by having the federal government reexamine the current safe harbor for drug rebates under the Anti-Kickback Statute?

Such a step could help restore some semblance of reality to the relationship between list and negotiated prices, and thereby boost affordability and competition.

But beyond discounting, a web of rules and restrictions – some implemented as a result of industry lobbying – prevent truly market-based pricing and competition.

Sometimes individual companies seek temporary advantage through the policy process only, in the long run, to erode the primary principles of competition.

I feel strongly that this is shortsighted. It’s hard to defend the principle of market-based pricing if individual firms seek to use legal and political maneuvering to seek temporary advantage by gumming up the rules in their favor.

I can tell you that the framework the Secretary has developed will dismantle many of the provisions that shield parts of the drug industry from more vigorous competition.

Part of this plan includes a series of changes to the pricing mechanisms in Part D. Taken together, these changes are a profound modernization of the program. It’ll put us more firmly on a footing to defend the idea that brisk competition should be the vehicle by which we seek to lower drug costs.

Similarly, the balance between innovation and access is also the foundation of Hatch-Waxman and the FDA’s generic drug program. This is where FDA’s efforts come into play.

Incentives to innovate, such as patents and statutory exclusivities, are balanced against abbreviated pathways for follow-on products that can enter the market once the innovator’s period of lawful monopoly no longer blocks approval. This is true for small molecules and biologics.

Last year, nearly 90 percent of all prescriptions in the U.S. were filled with lower cost, generic drugs.

Of course, competition isn’t inevitable whenever the patents and statutory exclusivities on a drug are no longer a barrier to approval. And we’ve seen too many cases where competition hasn’t taken hold at all.

That’s why last year we launched FDA’s Drug Competition Action Plan. We’re preparing a similar, Biosimilars Action Plan, which we’ll announce in a few weeks.

Under DCAP, we’re advancing a wide range of policies to promote and encourage greater generic competition, which can help to improve access and affordability of medicines.

To take one part of that plan, we’re building on our successes in improving the efficiency of our generic drug review process. Last year, FDA approved or tentatively approved more than 1,000 generic drug applications, a record for our agency. And we’ve completely eliminated our pre-user fee backlog of generic applications.

We’re also publishing guidance to help developers of complex generic products. We’re prioritizing the review of generic applications for products with low competition.

These are just some of the new steps we’re taking.

But one of the barriers to competition that concerns me the most is when companies “game” the system by taking advantage of certain rules and laws. They exploit loopholes in our system, to delay generic entry. In these ways, they extend a drug’s monopoly beyond what Congress intended.

For example, we see this when some branded firms use FDA’s REMS programs to prevent generic developers from accessing their drugs. In the process, the branded firms frustrate the ability of generic manufacturers to conduct the comparative tests necessary to win FDA approval of their drugs to enter the market. We’re going to be unveiling some new guidance in the next few weeks, as part of the President’s plan, which addresses some aspects of these loopholes that companies exploit when it comes to REMS.

We also see this gaming when firms use the 180 days of exclusivity awarded to certain first generics to block subsequent entrants for extended periods, by not launching their products, and not triggering the 180-day clock.

And we see this in certain abuses of the patent system, from improper pay-for-delay arrangements to creative licensing agreements designed to insulate firms from potentially legitimate patent challenges. We see this in other tactics, including perhaps a few of the ideas that some of the lawyers in this room may be developing right now.

To those who make a practice of advising clients on how to engage in this sort of regulatory arbitrage, my view is that your client is trading away the long run sustainability of the entire enterprise for very short run advantage and gains.

The issue is this: We’re not in the business of making widgets. We’re involved in a healthcare enterprise that hews to a higher calling. Companies draw on that special mission and purpose when they’re recruiting scientists into these endeavors, or advancing morale across their businesses.

But we can’t have it both ways. We can’t draw on the virtue of the life science work we do, and expect the public to give the life science complex some special credence because of its noble mission; while at the same time, seeing individual firms behave like this were any other enterprise, and try to subvert politics, policy, and the law for passing advantage.

The fact that we all work in the mission of making treatments that improve human health obligates us to a certain set of values, if we want that calling to also insulate these enterprises from some of the political intrusions that could undermine the incentives that are needed to underwrite the enormous investment and risks you all take.

We need to hew to a common set of principles if we want people to support these life science enterprises for the long run. When it comes to affirming the special mission of this industry, we need to walk the walk in everything we do.

I recognize that as lawyers, you have an obligation to advocate ardently on behalf of your clients’ interests.

To put it plainly, we also have a social contract to ensure that our actions are in the interest of public health. This is true whether we’re working in health care delivery, at the helm of a public health agency, or advising on corporate legal strategies that’ll affect patient access to necessary medicines.

Having a monopoly over the sale of a vital medical product is also a social contract. It’s easy to focus on short-term strategies to extend the life cycle of a profitable drug by holding competition at bay. And it’s probably more predictable to try and double-down on proven revenue streams when facing uncertainty in the research pipeline.

And, to be clear, I’m not saying there’s anything ignoble with taking legal steps to protect valuable IP and to pursue profits that we know help fund investment in risky new research.

But there comes a point when reasonable people would say that legitimate actions cross the line into gamesmanship and even, in some cases, unlawful anticompetitive conduct.

And when firms play these games, it’s not just competition that suffers. It’s the entire public that suffers including your clients. They suffer reputational harm in a market that’s more aware of the harms caused by the delays to competition, and doesn’t look kindly upon these actions.

They suffer the industry-wide, long-term consequences that come from undermining the careful balance between access and innovation struck by Hatch-Waxman and the other laws governing our framework for pharmaceutical development.

If these tactics don’t abate, there’s a real risk that Congress and others will come to see our longstanding – and, on balance successful approach to balancing innovation, access, and competition -- as a framework that’s no longer sustainable or worth supporting. That’s the risk that comes from an excessive focus on preserving incumbency rather than developing new innovations that’ll advance health, improve people’s lives, and also help grow the industry.

I realize most people in these enterprises are here for the right reasons. You’re public health minded, and work hard to deliver innovations that’ll advance human health. The problem is that a few bad apples, that game the system, can tarnish the entire brand of an otherwise principled industry.

So, we all need to call out these bad actors, and their tactics, for what they are. And take steps to thwart these strategies.

At FDA, we’ve been working hard to modernize our policies to help advance cutting-edge technologies. There are increasing opportunities for firms to develop lifesaving innovation that’ll cure more illness, and for lawyers to help advise FDA and companies on how we can best modernize our policies. I think we’d all agree that this work is far more meaningful in the long run than figuring out how to stave off competition on an old medicine. That’s where my focus is.

And it’s where I want to spend the balance of my remarks: On what we’ll be doing to advance these and similar goals.

In our Center for Drug Evaluation and Research, we’re focused on modernizing the new drugs regulatory program.

This will include a number of steps to adapt to new science and technology, advance our scientific leadership, and integrate and streamline our review process.

One goal is to make the development process more efficient and to make it easier to adopt drug development approaches that align more closely to the types of medicines that are being put into development. More of the new drugs we see work to target the mechanisms that give rise to disease.

As we get closer to treating the molecular changes that initiate disease, and not just the symptoms of illness, we’re also able to develop medicines that work to alter some of the fundamental biological systems that give rise to disorders.

We also know that the body is highly conservative. And so, the same molecular system that drives one disease may be at issue in the development of other ailments.

Drug development approaches like master protocols and basket trials make it easier to study drugs across different disease states. And so we’re laying out new guidance on how to adopt these and similar approaches.

We’re also going to be adapting our organization to these scientific changes. We’re going to cluster certain review divisions to better reflect current and emerging understanding. And we’re going to take a new approach to documenting our reviews, developing a more integrated document to foster collaboration across disciplines.

Our goal is to make drug review even more team based, so that the skills of FDA staff who have expertise in discrete areas like statistics and modeling and simulation and advanced manufacturing can be more easily leveraged when it comes to novel trial designs -- and more novel but promising development approaches -- are brought to us.

We want it to be easier to innovate the way drugs are developed. We also want to reduce the multiple and sometimes redundant memos that get generated as part of a review; and allow our medical and scientific staff to have more time to advance policy in their fields.

Our professional staff members are thought leaders in their disciplines. And we want to give them more time to collaborate with academic medical scientists and patients, to analyze scientific and commercial developments, and to strategically foster drug development – for example, by issuing up-to-date, disease-specific guidance.

We’re implementing similar reforms when it comes to our medical device program. We’ve recognized that FDA’s traditional approach to medical product regulation isn’t always well suited to emerging technologies like digital health. And if we want FDA, and our country to remain at the forefront of this kind of innovation, FDA itself must be as nimble and innovative as the technologies we’re regulating.

To these ends, last summer I announced our Digital Health Innovation Action Plan. The goal was to modernize the FDA’s approach to digital health. It laid out several new initiatives.

These include launching the FDA’s digital health software pre-cert pilot program, issuing new guidance to modernize our policies and promote innovation, and increasing the number and expertise of our digital health staff.

We’re going to be building on this approach, and seeking to apply it to other areas of new technology that have similar features to digital health -- areas where the cycle of innovation is similarly rapid and highly iterative. This includes certain molecular diagnostic tests, and digital health that incorporates features of artificial intelligence.

We’re also going to be taking new steps to improve our overall approach to medical device safety as part of our newly released Medical Device Safety Action Plan.

We want to focus more of our policy work on supporting product developers who are pursuing safer devices.

One way could be through a new program that’s similar to our Breakthrough Device Program. Under this approach, we’d provide greater interactions with developers and grant expedited review to their products where the key advantage is their enhanced safety over existing devices. We also want to make it easier for medical device manufacturers to make comparative safety claims about their products.

In these ways, we want to stoke more competition around the principle of designing medical devices that might deliver equivalent benefits to currently marketed products, but offer these benefits in a way that has added measures of safety.

For situations when FDA has identified new information that impacts the benefit-risk profile, we’re also looking at regulatory options to more efficiently require that companies implement appropriate post-market mitigations steps -- such as required user-training or updated labeling.

Similar to what we’re doing on our new drug side, we’re also implementing a total product life cycle approach to medical device regulation. The goal is to more closely integrate the pre- and post-market review functions. And to more closely align the cross-disciplinary expertise of our review staff into more integrated, cohesive, and collaborative review teams.

We’re seeing many new, more transformative devices.

But perhaps in no part of our portfolio do we have as many opportunities to cure intractable disease as when it comes to the products we’re seeing in our Center for Biologics.

Last year, we announced a comprehensive policy for the development and oversight of regenerative medicine products, including novel cellular therapies.

We plan to take new steps to build on that framework in the coming months, including through additional enforcement actions that target some of the bad actors in this field who have seized on the promise of regenerative medicine to make hollow claims and/or market unsafe products.

The bottom line is this: At the same time that we lay out a more efficient framework for how product developers can advance regenerative medicines through a flexible biologic review process; we’re also going to be taking enforcement steps to target those who market dangerous products that aren’t’ supported by credible, science-based evidence.

In the coming months, we also intend to further clarify our approach to the regulation of gene therapy. We’re going to provide a comprehensive framework that will include new guidance on manufacturing standards and approaches; as well as clinical guidance that lays out development pathways and potential accelerated approval endpoints for products that target specific disease areas like hemophilia.

We’ve reached an inflection point when it comes to gene therapy. The key enabling technology was the advent of more reliable vectors to deliver the target genes.

We’re now at a turning point where these treatments have the potential to become a backbone of modern medicine.

It’s similar to the inflection point when we first perfected the humanization of antibodies. It was a turning point in the use of antibodies as drugs. In a similar way, the advent of the lentiviral vector is an analogous product innovation that has opened up a huge clinical opportunity. Gene therapies using lentiviral and certain other vectors now hold out the promise of curative treatments for many vexing disorders.

Our obligation is to design a framework for the evaluation of these products that enables the efficient advance of these opportunities, while taking steps to ensure their safety.

When it comes to gene therapy, often the hard questions aren’t around efficacy. Many of these treatments look like they’ll be highly effective. Efficacy is often established early in the course of development, and in small series of patients.

The critical questions don’t necessarily turn on the clinical portion of the review, but on the product related issues.

These include the theoretical risks from off target effects, and on the durability of the response. They turn on complex issues associated with manufacturing and gene delivery.

A lot of the IP is also embedded in the manufacturing processes. And in some cases, we may be seeing product developers re-engineer these manufacturing processes in ways that may be geared less toward improving the products, and more toward circumventing some of the stacked royalties that exist in this field. Our job is to make sure these manufacturing changes don’t also introduce new risks. So we need to make sure we’re applying proper attention to all of these product-related regulatory issues.

In short, some of the hardest regulatory questions may turn less on the clinical evaluation of the technologies and more on the product specific and manufacturing issues that relate to the long run performance of these constructs.

This requires us to re-think our regulatory model when it comes to these products, to make sure we’re taking an efficient and science-based approach. Where the critical questions turn on long-term safety and durability, we need adequate policies to evaluate these products post approval.

For gene therapies that target serious conditions and offer potentially curative effects, the accelerated approval process may be ideally suited to allowing us to achieve a twin purpose – to expedite market entry while, at the same time, ensuring that we have strong post-market tools to continue to evaluate the safety of these product effects post approval.

Some of these same genetic tools are also being applied to animals, for both companion animals and those used for food production. Similar to how we approach these technologies as human drugs, we have certain obligations when it comes to the use of these same approaches in animals.

With new innovations such as gene editing, we need to lay out modern principles that allow these opportunities to advance while undergoing proper evaluation for their human and animal safety and environmental impacts.

To advance these opportunities, we’ve formed a biotech working group to advance our policy work in this area.

We’ll also be issuing new guidance that lays out our comprehensive framework for regulating genetically altered animals used for food as well as for medical purposes like the production of human drugs, organs and tissues for xenotransplantation, control of human disease transmission, or reducing human allergenicity. This includes how we intend to regulate gene editing in animals.

Now, I know that there are some who are trying to create what I consider to be a scientifically dubious distinction between performing small alterations to an animal gene such as a single nucleotide alteration through technologies like Cas9; versus larger genetic alterations, where whole genes are spliced in and out of a genome. And they want different policies with respect to how we regulate the same gene editing science when it’s used humans versus animals.

One of the arguments being made by some is that single genetic changes happen all the time in nature, as part of common breeding techniques. So why would we regulate the deliberate alteration of single base pair changes using Cas9?

Sure, single mutations to base pairs happen spontaneously.

But so do larger genetic changes. Are folks saying we shouldn’t regulate gene therapy either?

Nature splices and swaps entire genes all the time.

Whole arm translocations happen spontaneously.

Both big and small generic changes can have big impacts.

For example, cystic fibrosis and sickle cell anemia are caused by changes to a single nucleotide.

At the FDA, we plan to take a flexible and risk-based approach to how we evaluate genome editing.

But groups should be mindful that if they lobby for an exception when it comes to gene editing on the animal drug side of our house, it will inevitably undermine our regulation of these same technologies when it comes to human drugs.

And if we create these dubious distinctions, there’s a big risk that we erode confidence in these promising technologies before they have the opportunity to have their full impact on public health. I think the pathway we ultimately construct will be efficient and risk based. We plan an open dialogue around these principles and will solicit broad input.

But gene editing done in animals isn’t subject to different laws of nature than when these same tools are applied to people.

We’re also seeing significant opportunities when it comes to nutrition, and our ability to use diet as a tool for reducing the burden of death and disability from chronic disease.

A lot of our focus is on providing consumers with better information about the healthy attributes of food -- to give people a chance to make better choices about their diets.

This information also inspires competition among producers and to formulate food in ways that make it more healthful.

More Americans are looking for healthier food options.

This core principle is at the heart of our recent initiative to expand opportunities to allow food manufacturers to make voluntary claims on food products related to the healthful attributes of their merchandise. We’ll build on these steps in the coming year with new efforts to modernize our approach to standards of identity, new efforts to make the process for evaluating qualified health claims more efficient, and new efforts to redefine certain terms in regulation, like the definition of “healthy.” We also want to offer food producers voluntary ways to make the display of this information more prominent so consumers can make better use of these terms.

Food producers should be able to compete on the ability to develop foods that are healthier; and make reliable, science-based claims about these attributes to consumers.

We need to make it more efficient to develop claims around the attributes we want food to compete on.

Further we know that more clarity may encourage manufacturers to invest in making foods healthier.

These same principles underlie our efforts to promote the disclosure of basic information about calories on menus at chain restaurant and similar retail food establishments.

This provision goes into effect next week.

Whether firms are formulating food to be sold at grocery stores for meals people prepare themselves, or for meals served in restaurants, they should have the same incentives to compete on delivering healthy, affordable, and tasteful options. And food producers should have a level playing field when it comes to disclosing the nutritional content of their product, whether it’s a packaged food or a retail food setting.

That means implementing efficient rules to make sure that everyone provides some basic information about the nutritional features of the food they sell. That’s the principle behind the nutrition facts label that consumers see on food sold in stores. Competition depends on transparency, and a level and science-based playing field so consumers can make more informed choices when they buy food or eat out.

Now I know not everyone has supported restaurant menu labels. Not every fast food chain or grab-and-go food retailer wants to display calorie information.

But consumers want this data and Congress has mandated that it be made available. And the FDA has taken steps to make it easy to provide this information, in cost effective ways that are already found in many establishments.

That’s the point of the guidance we’ll soon release.

We took the concerns of we heard from some restaurants and similar retail establishments to heart, that it could be costly to display calorie information. So we lay out flexible options for complying with the requirements ranging from low-tech paper menus to electronic kiosks that are becoming commonplace in fast food chains around the country.

Moreover, materials that are used for marketing don’t have to have calorie counts on them. That picture of a delicious cheeseburger doesn’t require a calorie declaration.

And when it comes to build-your-own foods, like choose your topping pizzas, calorie ranges can be used to make the various combinations fit on a standard-size menu board.

We also provide more flexibility when it comes to the calories information that restaurants need to disclose.

We know that prepared food can diverge from one pizza slice to the next. So, we allow room for that variability. So you don’t need to worry about that extra piece of pepperoni.

In our food program, we’re also taking new steps to improve our overall approach to food safety. Nothing highlights the importance of food safety more than the terrible outbreak of E. coli O157:H7 infections from eating romaine lettuce. 

This outbreak has caused more than 100 illnesses across the country and one fatality.  And it occurred right on the heels of a similar outbreak late last year in Canada and the United States that was also linked to leafy greens.

These types of outbreaks are what the Food Safety Modernization Act was designed to prevent. 

They reinforce the importance of aggressively moving forward with FSMA’s Produce Safety Rule, which only a couple of months ago hit its first compliance date for large farms.  We’ve been working hard with our state partners and USDA to engage this year in training the farming community and conducting on farm readiness reviews so that we’re ready to begin inspections next year.

I know that some growers have raised concerns about parts of the produce rule, especially those that deal with agricultural water. But I visited with many farmers. I also know that no farmer wants to put their customers at risk.

The consequences can be tragic, as we are now seeing with romaine lettuce.  It’s also bad for business. 

Every one of us in this room is a consumer. 

I think we can all agree that now is the time to move forward to bring FSMA’s anticipated benefits to reality.

But no dietary advance, no new medical product, and no new enforcement steps could have the same public health impact as our ability to dramatically lower smoking rates in this country. Smoking remains the leading cause of preventable death and disease. And too many young people are still being initiated on tobacco products, and becoming addicted to nicotine. Increasingly, this is through the use of e-cigarettes.

We’ve taken steps to address the morbidity and mortality associated with tobacco through the comprehensive plan that we announced last summer. We’re considering regulating the nicotine levels in combustible cigarettes, to render cigarettes minimally or non-addictive. At the same time, the FDA’s regulation of both novel nicotine delivery products such as e-cigarettes and traditional tobacco products, will encourage the innovation of less harmful products while still ensuring that all tobacco products are put through an appropriate series of regulatory gates to maximize any public health benefits and minimize harms. 

Nicotine, while not a completely benign substance, isn’t what causes the death and disease associated with tobacco use.

It’s the combustion and associated toxins.

And it’s the nicotine that keeps smokers coming back to a lifelong addiction to cigarettes.

But nicotine exists on a continuum of risk; from the most harmful cigarettes to medicinal products like patches and gums that are so safe they don’t require a doctor’s prescription. We see an opportunity for new technology like electronic nicotine delivery systems to offer adults access to nicotine without all of the same harmful effects of combusting tobacco. This might also include e-cigarettes regulated as over the counter pharmaceutical products.

To advance that goal, we’ll soon release a draft guidance that lays out the toxicology testing that an e-cigarette would need to undertake to win approval as an OTC drug product.

At the same time we’re also jump-starting new work to re-evaluate and modernize our approach to the development and regulation of safe and effective medicinal nicotine replacement products such as nicotine gums, patches, and lozenges that help smokers quit.

This is a pivotal part of our overall public health approach.

But access to e-cigarettes can’t come at the expense of a whole generation of youth becoming addicted to nicotine through these electronic products.

So, we’re going to be continuing to take an escalating series of actions, including against the companies that market these products in ways that may be deliberately enticing to youth, and the retailers that are selling e-cigarettes to kids.

We recently took action to address JUUL. And we’ll be following up with the manufacturer.

If we don’t get the information we demanded, or if those documents raise new questions, we’ll explore all of our options, including enforcement actions. We’ll use our authorities forcefully, to target youth use of e-cigarettes.

Companies that know children are using their products are on notice. If you target kids, then we’re going to target you.

At the same time, we’ll be taking new steps to make combustible products less appealing to kids. One focus of my attention is the characterizing flavors that remain in some combustible tobacco products, including menthol in cigarettes and fruity flavors we increasingly see in cigarillos.

FDA didn’t take action on menthol in cigarettes or flavors in cigarillos in the final deeming rule.

That opportunity remains before us.

The flavors ANPRM we released last month seeks information to inform potential regulatory actions FDA might take with respect to flavors in tobacco products, which include a ban on flavors in combustible products.

Flavors are a problem.

They entice kids to initiate on cigarettes. Menthol may make it easier to hook young smokers. We have the legal authority, and public health obligation, to address these risks.

Finally, the bedrock of our consumer protection mission and the common thread that binds our public health functions is our field force and the enforcement work we do to protect Americans. Thanks to new resources we received as part of the Omnibus, we’re substantially increasing our enforcement footprint in the International Mail Facilities.

We’ll be stepping up our interdiction work when it comes to foreign unapproved and counterfeit drugs, as well as controlled substances, that are shipped through the mail. Later this year, we plan to release some new data on the volume of counterfeit and illicit products being shipped in the mail, and the steps we’re taking to stop them.

We’ll be seeking additional ways to improve our overall approach to our field activities. As part of the 2019 budget, we’re seeking resources to improve our forensic labs and expand certain inspectional work. Our Office of Regulatory Affairs is the bedrock of our public health enterprise.

Supporting ORA’s mission is one of my highest priorities.

These are just some highlights of what we’re focused on as we look ahead to 2019. We’ve been active over the past 12 months in advancing policies to promote the FDA’s public health goals. We will maintain the pace of that work.

We have many policies and programs we’re in the process of planning that we look forward to sharing soon. We have additional enforcement measures underway.

Our success is dependent on the community that supports our endeavors. Many members of that community are here today. So on behalf of the FDA’s professional staff, I want to thank you for the work you do to support our mission.

The public health goals we all share animate the work at the FDA. It gives our institution a distinctive spirit. I believe that the FDA is a crown jewel among government enterprises.

It’s a unique and singular institution with a critical mission, a distinctively skilled professional staff, and a community of experts who share and support our common purpose.

Thank you.