Strengthening Enforcement and Consumer Protections August 3, 2017

Speech | In Person

• Speech by: Scott Gottlieb, M.D.

Remarks by Scott Gottlieb, M.D
Commissioner of Food and Drug Administration
to the Office of Regulatory Affairs (ORA) Senior Management Team
White Oak, MD

I’m delighted to join you today as we advance the enterprise that you all set in motion, with the launch of Program Alignment. FDA’s field operations are the cornerstone of our consumer protection mission. You are FDA’s front lines. All of you, collectively, are the instrument of the most fundamental aspect of this agency’s public health role.

If you study FDA’s history, its charge began with its inspectional role. And this impetus for FDA’s inception is still the bedrock of its present mandate. Program alignment will secure that mandate for the long run – and allow us to adapt to evolving challenges and new opportunities.

I realize we still have more work to do in implementing this new vision. This modern transformation of our inspection resources and our footprint will remain the blueprint for our policy work for many years. And I want to thank all of you for helping to lead this important effort.

Program alignment is part of a much broader, agency-wide effort to modernize and strengthen our workforce. We believe that ORA’s new specialization will enable us to improve our public health response with more focused resources and timelier decision-making.

We need to make these changes together.

The intricacy of the products and facilities we’re tasked with regulating is increasing, along with the complexity of the supply chain. This marketplace -- and rate of innovation -- requires us to re-think how we organize our field resources. It requires us to reconsider how we implement the procedures related to our principal oversight role.

A key aspect of Program Alignment is implementing a program-based management structure. This arrangement aligns a large segment of staff and their managers by FDA-regulated products areas, rather than by geographic region. Organizing our resources and activities by product areas will improve coordination between FDA’s centers and ORA. It will ultimately increase accountability and collaboration.

I believe that our work in the field should be closely integrated with our regulatory programs and the work of our product centers. We need to make sure that our people working in the field are collaborating closely with review teams and others working in headquarters. Each camp will benefit from shared learning and the chance to work together to align more of our efforts squarely behind our consumer protection mission.

The new structure will enable staff to work more closely with FDA scientific and technical experts on complex, scientific, manufacturing and other regulatory challenges. All specialized staff in a given program will be trained similarly, so that industries across the globe experience uniform application of our regulatory standards. It’s my hope that by deepening our knowledge by area of specialty, we’ll strengthen ORA’s ability to regulate an increasingly complex and global industry.

This close alignment is going to be important as we address new policy challenges and new policy goals. One of those policy goals that we announced last week relates to tobacco. We’re pursuing a policy that will put nicotine at the center of our tobacco regulatory efforts.

First, we announced that we intend to pursue the regulation of nicotine levels in combustible cigarettes. Our aim is to render combustible cigarettes minimally or non-addictive.

At the same time, we’re also pursuing a series of policies that we believe will allow new innovations that, properly regulated, have the potential to allow adults to have access to nicotine through products that could pose substantially less risk than lighting tobacco on fire.

ORA will be a key to the success of this policy.

For one thing, as we seek to reduce nicotine levels in combustible cigarettes, a key aspect of this policy will turn on our ability to prevent the evolution of an illicit market for cigarettes that contain higher levels of nicotine. There’s also a lot of analytical work that needs to be done in implementing such a policy. I see the tobacco lab in Atlanta, and our Forensic Chemistry Center, playing important roles in these efforts.

Your work is also a key to the continued, successful implementation of FSMA and our new food protection authorities. I’ll be visiting with farmers in Georgia this month, and taking some similar trips this fall. The timely implementation of the produce safety rule, along with the other components of FSMA, is a high priority of mine. Our ability to implement the inspection requirements in an efficient and effective way is going to be a big part of the success of this entire program.

Across all areas, closer alignment will also improve accountability and better inform everyone’s work. The new alignment will allow investigators to continue to grow their expertise in the core areas that FDA regulates. This kind of focus is critical, as our oversight work become more intricate, and risks we confront grow more perilous.

There’s one risk, in particular, that I wanted to spend some more time talking about. It’s a significant concern of mine. It’s the risks associated with the growing trade in illicit and often synthetic opioids like the fentanyl that we see coming into the United States. I’ve made issues related to opioid addiction my top priority since coming to FDA. And as you know, it’s one of the highest priorities of Secretary Price and HHS.

For most people who become addicted to opioids their first exposure will be through a lawful prescription that was written for a medical purpose. In most cases, that prescription will be for an immediate release formulation such as Vicodin or Percocet. About 90% of all prescriptions are for these immediate release opioid drugs.

We know that a certain percentage of people who are exposed to opioids in the medical setting will become long-term users of these drugs. Some of these people will develop an addiction. And still others will move on to higher dose formulations of opioid drugs to sustain their addiction. Some will eventually migrate to the lower cost alternatives – which are increasingly illicit street drugs.

This includes heroin and extremely potent, and often deadly, synthetic drugs like illicitly made fentanyl. Some addicts and users often move on to illicit, synthetic opioids because of their lower cost, and high potency. The synthetic opioid drug market is constantly evolving and growing. It’s been challenging to track and to enforce against.

We must do more to confront these challenges. And I know that all of you are committed to this effort, and I know that the professional staff of ORA has been making progress confronting these risks.

The public health risks are staggering. Just from 2014 to 2015, the CDC estimates that the death rate from illicit opioids other than methadone, increased by 72.2%. This includes fentanyl. Over the same time, heroin death rates increased by 20.6%. Rates of death involving heroin and illicit, synthetic opioids other than methadone increased across all demographic groups, regions, and in numerous states.¹

We know that a lot of these illicit drugs are coming in through the global postal system. Packages that are sent through private carriers require electronic data that helps Customs and Border Protection target specific dangerous shipments. That helps us intercept illicit drugs. But foreign postal services are not required to include this data.²

According to a report by the U.S. China Economic and Security Review Commission; “U.S. law enforcement and drug investigators found that China is the primary source of fentanyl in the U.S.” As a consequence, we know that a lot of these illicit drugs are coming in through International Mail Facilities. More than 340 million packages reach the United States every year. It’s estimated that only a small percentage of the illicit drugs smuggled through the IMFs are being intercepted.³

The challenge for all of us is significant. The IMFs inspect international mail arriving from more than 180 countries. We often lack advanced manifest data that would aid in targeting shipments. The hazardous nature of various types of synthetic drugs presents additional challenges. Processing inbound international mail is primarily manual and requires CBP officers to sort through large bags and bins by hand.⁴

For our part, at FDA we are typically asked to analyze packages that are pulled by CBP, and believed to contain drug products. I know that there’s been a lot of good work done at FDA to address the risks posed by drugs coming in through the IMFs. But given the scope of the opioid crisis, and the risk posed by these synthetic drugs, it’s my belief that we need to devote even more resources and attention to these risks.

I’ve worked with Mel Plaisier and the leadership of ORA to devise an Enforcement Operations Work Plan focused on foreign unapproved drugs. Our policy efforts are aimed at increasing the scope of our operations related to these risks. Mel has made a deep commitment to extend ORA’s footprint over these efforts. Working together, we’ve developed a multifaceted effort that will extend over many months.

I’ll have much more to say on this next month. But I wanted to frame my concerns for you today, and why I’ve asked Mel to devote more attention to these risks. I wanted to discuss some of our initial actions.

Among other things, we’ll be increasing FDA resources devoted to these efforts. We’ll also be seeking to carve out some additional authorities that I believe will help us improve the force of our efforts.

To start, we’ll almost triple the staff we have in the IMFs, to improve our ability to inspect packages that are suspected of having drugs. This will take our footprint from 8 to 22 FTEs and will staff the IMFs to the maximum capacity that our space in these facilities allows. We’ll also be doubling the number of port of entry special agents that the Office of Criminal Investigations maintains from 6 to 12 FTEs.

In addition, we’ll be increasing the OCI’s very successful Cybercrime Investigations Unit, its Strategic Intelligence Unit, and its Intelligence Analysis Branch from 11 to 21 FTEs. This past June, this team supported the intergovernmental effort to takedown a massive Dark Web Marketplace named AlphaBay.

And to support the additional work that we expect these stepped up efforts to generate, we’ll add five additional laboratory analysts at FDA’s Forensic Chemistry Center. We’ll also be investing significant additional resources into more equipment inside the IMFs and our laboratory to assist in these efforts at the various ports of entry.

To complement all of these efforts, we’re also going to seek certain administrative steps to expand the strength of our regulatory oversight. We may also seek some additional, limited resources and authorities from Congress. I plan to have more to say on all of these and other steps next month, when we announce the full Work Plan.

The risks related to illicitly made fentanyl is just one example of how quickly new threats can emerge, the tough the challenges we must confront, and the dangers Americans face from these emerging risks.

It’s a reminder of how hard our mission is, and the vital role you all play in protecting Americans. You’re on the front lines of FDA’s consumer protection mission. And I want you to know that I’m committed to your work. To supporting your efforts. And to making sure that the policy steps that we take together will make this program stronger.

It’s a pleasure to be here today, and to be working with you. I’m looking forward to visiting with your offices and laboratories across the country and meeting your staff. I have some of those trips already planned, and will scheduling all of them through this fall. I look forward to speaking with many of you individually, and I’m honored to join you today.

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¹https://www.cdc.gov/mmwr/volumes/65/wr/mm655051e1.htm
²http://securepackages.org/in-the-news/
³http://radio.wosu.org/post/how-opioids-slip-through-postal-service-one-big-loophole#stream/0
⁴https://www.dhs.gov/news/2017/06/27/written-testimony-cbp-house-judiciary-subcommittee-crime-terrorism-homeland-security