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Speech | In Person

Event Title
Remarks to the FDLI Enforcement, Litigation, and Compliance Conference
December 12, 2018

Speech by
Scott Gottlieb, M.D.

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
FDLI Enforcement, Litigation and Compliance Conference
Washington, DC

(Remarks as prepared for delivery)

This conference is an opportunity for those of us engaged in compliance and enforcement – regulators, investigators, prosecutors, compliance officers, legal counsel, and many others – to gather and discuss our shared enterprise and our shared public health goals.
Our enterprise genuinely is collective.

While the people in this room have diverse roles and responsibilities, we all have a common commitment. We have a shared obligation, to advancing the public health and keeping patients and consumers safe.

These obligations span across our work. All of us have an obligation to help make sure that FDA-regulated products meet the right quality and safety standards; that they’re being marketed appropriately; and that the related research is conducted with adequate protections.

Perhaps the most obvious obligation we all share is -- in a certain sense -- also our most humble duty: It’s our commitment to follow the law.

But I think we all understand that there’s more to it than that – and not just because many regulatory requirements can be highly complex.

As important as it is to adhere to the law for the sake of compliance alone, I know that for many of you, the obligations run much deeper. It means fostering a culture of compliance under which following best practices, and the requirements of the law, isn’t just a way to avoid liability. But it’s also an expression of our shared values and our shared commitment to serve as good stewards of the public health and trust.

As I said this past spring when I spoke at the Food and Drug Law Institute’s annual conference, we’re not in the business of making widgets. Those engaged in these FDA-regulated enterprises have a higher calling than that; and we have more fundamental obligations.

Those who make and sell medical products are participating in a noble health care enterprise. Patients and providers should be able to trust assurances that products meet the gold standard of quality to which they’re held, and that they’re marketed truthfully and responsibly.

Similarly, we expect those who produce and distribute the food we eat to meet certain safety standards, and to provide information so that consumers can make informed decisions. And we all expect that those who sell tobacco products must do what’s required to make sure that these products aren’t addicting a new generation of kids onto nicotine.

This isn’t just about managing legal risk. It’s about our shared values, and the obligations we owe patients and consumers who depend on us.

I don’t think I’m saying anything that most of you here don’t already know, already share, and already live by. The overwhelming majority of firms take these obligations seriously. Firms should be able to – and by and large they do – manage their compliance obligations proactively, without the need for the government to step in and take enforcement action. This is something to be proud of. And, frankly, it’s critical for maintaining the public’s support and confidence in the long run.

At the same time, violations do occur. And often they can endanger the public health. The FDA plays a critical role in identifying these instances of noncompliance and making sure that they’re properly addressed.

In many cases, the noncompliance may be unintentional, such as the good faith mistakes of a firm that cares about doing things the right way. Often, in these cases, we’re able to work together to address the public health risk and achieve compliance.

In some cases, however, the misconduct runs deeper.

Sometimes, we see a willful disregard for the rights or even the safety of people who’ll be affected by products being put into the marketplace. This comes up in many contexts: intentional adulteration; fraudulent regulatory submissions; the sale of counterfeit, substandard, or unapproved medical products; or fraudulent marketing.

In such cases, the FDA – often working together with our colleagues across government, including at the Department of Justice -- has an obligation not just to step in and address the public health risk, but to do all we can to take actions that deter future misconduct.

That means sending a clear signal to would-be bad actors that whatever the economic incentives for the misconduct – and those incentives may be significant – we have the tools, the resources, and the commitment to identify violations, penalize bad actors, and protect the public health.

This obligation to address misconduct – both intentional and unintentional – is one of our most fundamental responsibilities at FDA.

But our ability to meet this obligation rests in large part on how well we execute on the FDA’s other, related obligations.

Today, I’d like to highlight some of the concrete ways that FDA is working to meet these obligations – to use our resources wisely; to develop modern, efficient, and risk-based programs; and to solidify and extend our efforts to enforce the law energetically to protect the public health.

We take great care in how we discharge these obligations.

Our agency has finite resources, and we need to be thoughtful about how we use them. If we squander our resources on inefficient operations, or on activities that aren’t protecting or advancing the public health, we’ll undermine our public health mission by leaving fewer resources available to target the areas of highest risk.

A related obligation is our responsibility to be thoughtful about the requirements we impose on regulated parties. It’s incumbent upon FDA as a regulator to recognize that complying with regulatory obligations is not a cost-free enterprise. When we impose requirements on firms that will cause them – and us – to invest resources in compliance, we need to make sure the burden is justified from a public health perspective.

Part of how we do that is by listening to stakeholders – regulated parties, enforcement partners, health care providers, patient and consumer groups, and others. We want to make sure that we have the best possible understanding of the impacts our requirements may be having.

At the heart of many of these efforts is the work of the FDA’s Office of Regulatory Affairs, or ORA. The men and women of ORA are FDA’s front line. They are the leading edge of our critical consumer protection mission. They’re the foundation of our most basic commitments and duties as an organization. These are the investigators who identify violations, the special agents who pursue potential criminal violations, our field force that screens imports, our labs whose regulatory science underpins that work, and many others dedicated to FDA’s mission.

Since I became Commissioner over a year and a half ago, one of my top priorities has been to make sure that ORA has the tools and systems necessary to succeed. ORA’s success is critical to our mission of protecting the public health through regulatory compliance.

It’s all too easy to try to measure success strictly by the numbers – how many inspections we perform, how many imports we’ve reviewed, how many arrests or prosecutions we’ve delivered, and so on.

Statistics like these matter. But they’re not the whole picture, or sometimes even the most important part of the picture.

Success isn’t just about how many resources we’re deploying.

It’s about how well we’re deploying these resources, and how much impact they’re having in advancing the agency’s public health mission.

We need to ask questions like: Are we targeting the right establishments? Are we assigning the right investigators, with the right experiences? And are we effectively using our resources across the FDA, and working effectively with our partners outside FDA, to identify violations that put the public at risk, and to address them appropriately?

FDA continues to grow stronger by each of these metrics.

In May of 2017, we implemented our Program Alignment plan, which aligns ORA’s staff by FDA-regulated product, replacing an older management structure that was based on geographic regions.

Under this program-based management structure, ORA’s inspection and compliance staff –including their managers – and ORA’s laboratories are specialized by product type. In the long run, we believe this will allow us to bring greater expertise and consistency to our field operations.

Specializing by FDA-regulated product type more closely mirrors the organizational model of the FDA’s centers and the industries we regulate. This enhances coordination within the Agency and advances our ability to keep pace with innovation and protect public health.

We’re also improving how we target which establishments to inspect based on risk. Until recently, FDA was required by statute to inspect many drug and device establishments at set frequencies, which made it difficult for FDA to prioritize inspections based on the risk they posed.

That’s changed. Under the FDA Safety and Innovation Act of 2012, and the FDA Reauthorization Act of 2017, Congress removed that requirement for drugs and Class 2 and 3 devices, respectively.

This allows FDA to set its inspection schedule using risk-based criteria such as compliance history and the inherent risk of the product.

We’re using this authority to focus our resources on inspecting domestic and foreign manufacturers whose products and processes pose a greater risk to the public health. This approach enables us to more readily identify the most serious situations, resulting in more targeted oversight and timelier actions to address the problems we identify.

We’ve also been able to work toward clearing the backlog of drug establishments that have never been inspected by the FDA. We’re on track to complete this effort in the current fiscal year.

And we also continue to improve our ability to evaluate establishments based on their risk, and target our oversight work accordingly.

In October 2018, we implemented a first-ever concept of operations agreement between ORA and the FDA’s Center for Drug Evaluation and Research (CDER) to more fully integrate our drug review and inspection programs. This new, team-based approach will allow the agency to more closely consider all the factors that may affect risk, leading to better information sharing between our review staff and our field force. We want to expand this model to other areas of our regulatory portfolio.

There are some common themes to the risks we see. One is data integrity. As we’ve inspected establishments, one thing we’ve uncovered too often is situations in which drug quality data and information aren’t accurate. And so, data integrity has become a big focus of our oversight.

These risks can mask problems and failures with product quality and safety. FDA has been focusing additional resources on efforts to prevent, uncover and combat such lapses, whether they’re the result of deceptive practices or, as is more common, the result of inadequate processes and systems. Even as we’re uncovering more risks, we also have new ways of addressing these lapses. The same digital tools that give bad actors increased opportunities to manipulate data, also give the FDA new capabilities to spot these deceptions and uncover rogue actors. We’ve used these improved capabilities to focus new efforts on these risks, and to train our staff on identifying concerns related to data integrity.
We’re building on these policies by taking some new steps that I want to announce here today and brief you on in more detail.

First, we’re updating our guidance for industry on data integrity. The new guidance will help manufacturers address identified data integrity lapses, implement best practices to address gaps that can create risks to data integrity, and ensure consistent awareness and commitment to ensuring data integrity. Our goal is to arm industry with the tools to prevent data integrity issues. But we’ll continue to focus resources on detecting violations and taking enforcement actions as appropriate.

We’re also making improvements to how we assess inspection results.

For example, in the drug space, we’re launching a New Inspection Protocol Pilot, which uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of our findings. We’ll be piloting this approach with our oversight of sterile generic drug facilities.

This new, more templated approach to conducting inspections – and collecting and reporting on the findings -- will allow us to bring more predictability to not only how we perform inspections, but how we report on information that can help FDA and other parties assess the overall quality of a facility. We hope with a more structured approach to the conduct of inspections, and collection of findings, we can develop better tools for evaluating the overall quality of an operation and move away from a system where those assessments are made indirectly based on more inexact evaluations of the individual findings. If this new method works in this context, we believe we may be able to adopt a similar approach to our inspectional work in other areas of our portfolio.

The idea is to have a better, overall assessment of the quality of a facility, and take steps to reward facilities and firms that exhibit excellence.

And, in our device program, we’re working to share inspection findings and concerns with parties sooner after they’re identified. Sometimes we can get to compliance faster when we engage in early and decisive dialogue. In many cases this allows us to shift away from contentious, and often lengthy, letter exchanges and enforcement action.

Another critical improvement to our inspection program is our increased ability to leverage the high-quality work of trusted foreign regulators.

We’ve been working with our counterparts across the globe to improve regulatory oversight through cooperative agreements that reduce duplication of efforts and improve information sharing.

Through these agreements, we can better target risk, and expand our collective reach. We can do this while reducing the burden on industry of overlapping inspections and requests from multiple jurisdictions.

To advance these efforts, the FDA and the European Union (EU) have entered into a Mutual Reliance Agreement that allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders. As we’ve completed the work of assessing the way that each authority in the EU inspects drug manufacturers, we’ve begun to rely on the work of many of the highly regarded EU authorities.

For example, the FDA and many foreign regulators are participating in the International Active Pharmaceutical Ingredient Inspection Program. This program established a framework for sharing information on GMP inspections of API manufacturers worldwide to avoid unnecessary duplication. Recently, this framework has allowed for information sharing regarding planned inspections of valsartan API facilities.

And the FDA, in collaboration with foreign regulatory partners, has also helped establish the Medical Device Single Audit Program. Under this program, a single regulatory audit of a medical device manufacturer’s quality management system can be used to satisfy the requirements of multiple regulatory jurisdictions. The FDA has received and classified nearly 600 audits and the program continues to expand.

In the foods space, we’re putting in place Systems Recognition agreements to essentially do the same – leverage the high-quality work of regulatory partners in other countries so that we can better target our resources to higher risks. We have agreements with Australia, New Zealand, and Canada, and are working on an agreement with the EU.

Outside of our inspection program, FDA has been working to improve our ability to keep dangerous and illegal products off the market.

To improve the security of the pharmaceutical supply chain, we’re working to fully implement the Drug Supply Chain Security Act in 2023. This includes working with members of the supply chain at our public meetings held over the last year and a half. Fully implementing our track-and-trace requirements is critical, particularly given the rise of sophisticated criminal organizations that intend to profit from the introduction of counterfeit or otherwise illegal drugs into the U.S.

We’ve also implemented new authority to require mandatory recalls of dangerous food products. This year, we published final guidance on how we intend to use this key enforcement tool, and we already exercised it, using the order mechanism under the statute for the first time, to mandate a recall of food products containing powdered kratom due to salmonella contamination. When the liable party won’t act to remove dangerous food products from the market; FDA will force the action.

We’re also enhancing our ability to intercept illegal shipments at the border. We face a flood of dangerous products entering the U.S. through internationally shipped mail packages. The FDA is on the front line to stop these packages, particularly those containing substances that aren’t, or haven’t yet been, scheduled under the Controlled Substances Act. It’s no small task given the estimated tens of millions of imported packages each year that we estimate contain FDA-regulated products. But, with help from Congress, we’re stepping up these efforts.

In March, Congress appropriated an additional $94 million to fund critical work at the international mail facilities (IMFs). With these new funds, we’ll be able to triple our number of full-time inspectors at these IMFs. There were eight people exercising this mission when I became Commissioner. We increased that number to 21 using resources we found internally. With the new money from Congress we’ve taken that number to approximately 40 today. With these new funds we are continuing the process of hiring to reach about 76 people covering the IMFs alone, and an additional 49 spread across our criminal office and laboratories.

With these additional resources, we expect to substantially increase the number of packages that we can open and review. We’ll also invest in critical new scientific tools that allow us to better detect and identify dangerous or counterfeit drugs that are being offered for import.
We were also pleased last month when the President signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. This bipartisan legislation grants the FDA important new authorities to help us interdict illegal drugs and advance our efforts to address the opioid crisis.

One new authority will enable FDA to efficiently detain, refuse, and destroy unlabeled imports that are found to contain active ingredients or analogs of active ingredients that are in FDA-approved drugs.

In the past, the law required the FDA to determine the intended use of every incoming unlabeled article that might have been a drug before we could proceed against it. This was cumbersome work that sometimes presented challenging legal issues, and it made it hard to keep up with the volume of shipments we faced. The new authority will allow us to remove more potentially dangerous drug products from the supply chain more easily, and it’ll let us expand the scope of our efforts.

Perhaps our most important resource at the IMFs has been our close partnership with U.S. Customs and Border Protection. CBP’s efforts in identifying and referring shipments have helped us to launch more than 550 criminal port-of-entry investigations in fiscal years 2017 and 2018.

These efforts have helped us hold criminals accountable.

We’re also taking robust action to address the illegal distribution of opioids online. Earlier this year, CDER hosted FDA’s first Online Opioid Summit. This included academic researchers, advocacy groups, government, and leaders of some of the largest Internet and technology companies in the U.S. to discuss ways to collaborate and take concrete steps to reduce the availability of opioids online.

The Summit was successful. It paved the path forward for future collaborations by FDA with these key Internet stakeholders.

I’m pleased to report that since the announcement of the Summit, Internet stakeholders have taken concrete steps to combat the illegal sale of opioids through their platforms and services. For example, Google de-indexed web pages from organic searches based on FDA’s warning letters that cite illegally distributed prescription drugs, including opioids, that risks physical harm to consumers. Facebook and Instagram also started redirecting users who look to buy opioids online to the Substance Abuse and Mental Health Service Administration National Helpline.

We’re continuing to engage with these firms to shield the American public from dangerous drugs that are offered online. We’re planning to host a second Online Opioid Summit in the early part of next year, where we can build upon these successes and protect consumers. We’ll be announcing more details about this upcoming summit soon.

FDA also has an ongoing campaign to issue warning letters to networks operating websites that illegally offer opioids for sale to U.S. consumers. Since September 2017, CDER has issued warning letters to 23 networks operating more than 450 websites illegally offering opioids for sale online. In collaboration with our DOJ colleagues, the FDA works to seize domain names when possible to prevent online opioid sales.

Last year, about 100 website domains cited in the FDA’s warning letters were seized. To ensure a comprehensive approach to this oversight, we also notify the registries and registrars when we send warning letters to website operators. We want the registries and registrars leasing the domain names to know the sites are illegally sell opioids online.

We recognize that when an industry comes under new oversight, there can be a learning curve. And it’s incumbent upon the FDA as a regulator to make sure we’re providing both the guidance, and the oversight, necessary to protect the public health through compliance.

This has been especially true for our compounding program.

In 2012, 753 patients across the nation were infected, and 64 patients died, after receiving injections of a contaminated drug produced by New England Compounding Center. In the wake of that tragedy, FDA worked with Congress to establish a new statutory framework with greater protections for patients. Fully implementing that framework, and helping industry to come into compliance, is a key priority.

To help industry come into compliance, we’ve been making efforts on all fronts – providing clear guidance that describes our expectations, conducting rigorous inspections to help firms understand what needs to be improved, and taking swift action when we encounter conditions that put patients in harm’s way. That includes criminal enforcement.

We still see a lot of concerning activity continue in this space. We’ll do everything possible to prevent another tragedy like 2012 from ever happening again. We are committing to put new resources behind these efforts. We’ll use all our enforcement tools to protect patients; and we have a number of civil and criminal investigations underway in this area.

In the last year and a half, we’ve worked with our partners at the DOJ to reach multiple consent decrees enjoining compounders who persisted in violating the law and putting patients at risk. We’ve been fully committed in pursuing these violations, and we’ve overcome creative legal defenses. And we’ll continue to do so.

Last year, I convened an internal FDA task force, including senior officials from across the FDA, to take a hard look at our compounding enforcement operations and make sure that we’re being as energetic as possible. Thanks to the work of this task force, we’re piloting new processes to more quickly send referrals to our partners at DOJ.

We’re also committed to taking decisive enforcement action in other areas where we need to address significant risks to the public health.

This past spring, we initiated enforcement actions against two stem cell clinics to stop them from marketing products without the appropriate FDA approvals. While cell-based regenerative medicine holds significant medical promise, we’ve seen bad actors leverage that scientific opportunity to peddle unapproved treatments that put patients’ health at risk. When we see such risk, the FDA won’t hesitate to act.

We’ll be stepping up actions in this space in the coming months. Expect to see brisk activity from the FDA when it comes to some rogue stem cell outfits that are putting patients at risk. We’re also going to be putting many more firms on notice that we’re aware that they’re manufacturing cell and tissue products that are subject to our oversight. And we expect to hear from them.

Another area where we have a successful track record working on both criminal and civil cases with our partners at the DOJ zelis dietary supplements. We’ve encountered a range of problematic conduct in this space as well. Some products marketed as dietary supplements contain dangerous and illegal ingredients, often without identifying them to consumers. Some contain lawful ingredients, but their manufacturing processes fall far short of GMPs that are needed to assure a quality product. And others make illegal and unproven claims about their ability to treat serious diseases. We take seriously our obligation to protect consumers from all of these dangerous products.

The dietary supplement industry has grown significantly from where it was 25 years ago. What was once a $4 billion industry of about 400 products is now an industry of over $40 billion and more than 50,000 products. And while much of this industry is responsible to consumers and the public health, there are also too many bad actors who are not.

With the growth come new opportunities for consumers to improve their health, but also a lot of new risks. And I’m concerned that the industry has gotten bigger and riskier faster than our policies and our capacity to manage this risk. That needs to change. And so we plan on advancing new policies that will improve our oversight in this space.

I’ve formed a Dietary Supplement Working Group within FDA to take a hard look at what more the FDA can be doing within our existing authorities, including re-examining our own internal operating structure and procedures – and what new authorities might make sense.

We have some specific, new policy measures that we plan to pursue when it comes to modernizing our overall approach to dietary supplements. You’ll be hearing more from us on that front very soon.

These are just some of the ways that FDA is working to protect and promote the public health through greater compliance. All of us are partners together in a shared public health enterprise. And by working together, we can better achieve our shared public health goals.

Thank you.

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