Speech by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
FDA OCI Meeting
Kansas City, MO
November 14, 2017
It’s an honor for me to join you today as we gather to advance FDA’s criminal law enforcement operations. Because of the Office of Criminal Investigations’s nationwide presence, it’s not often that we have the opportunity to all gather in the same place and I understand this is the first time in OCI’s 25-year history you have met as an office.
Criminal wrongdoing involving FDA-regulated products is a nationwide problem—and, increasingly, a global one.
To confront this threat, FDA’s OCI has operations across the country, and even across the globe.
You’re on the front lines to protect the public health from those who would undermine it through criminal misconduct.
So, I’m delighted that I could be here to thank all of you together for the critical work that you do to protect Americans and advance FDA’s vital public health mission.
Since OCI opened its first field offices in 1993, including one right here in Kansas City, our operations have grown to confront the spread of dangerous criminal actors operating across the globe. These operations are at the heart of advancing critical public health FDA priorities.
OCI investigations are a key to stopping the criminals both foreign and domestic, who introduce dangerous counterfeit, unapproved, or misbranded medical products into the domestic supply chain. You have also investigated and successfully brought cases related to unapproved medical devices, contaminated foods, counterfeit veterinary products, as well as counterfeit tobacco.
OCI’s work has been essential in stemming the tide of cybercrime involving black market sales of diverted or substandard prescription drugs. And we rely on OCI every day to help stop the fraudulent marketing of medical products that can put patients’ lives at risk.
These are just a few examples of the important work you all do that ranges across all of our product areas. And I want you to know that I appreciate how valuable your work is. Not just to the agency overall, but to advancing some of my highest priorities as Commissioner, as well as the welfare of Americans.
There is one priority in particular that I’d like to focus on today. That’s the opioid epidemic that’s devastating communities across our nation.
Addressing this crisis has taken precedence for me since coming back to FDA. And OCI has been instrumental in helping to hold some of the worst criminal offenders to account. I want this work, and combatting challenges related to opioids, to be one of your highest priorities as well.
But there’s more we can, and must, be doing to penalize and deter the criminal misconduct that contributes to and worsens this crisis.
To be clear, criminal investigations and enforcement are just some the many different tools that FDA and others will need to bring to bear against the opioid crisis. The crisis has reached the point that we will need to take an aggressive, comprehensive, and all-in approach to combatting it.
This is something the President and the Acting Secretary of Health recognized in declaring the opioid crisis a public health emergency.
A comprehensive approach means we need to focus on the full range of conduct that contributes to the crisis, both lawful and unlawful.
And we need to find better ways both to help those who are already addicted to opioids and to prevent new cases of addiction.
A major challenge in regulating opioids is that although these drugs can pose a significant risk of addiction, abuse, and misuse, they also can provide significant benefits when used in appropriate ways by appropriate patients. For example, opioids can be highly effective in treating people who suffer from severe and debilitating pain, such as certain cancer patients. But the drugs’ addictive potential, and their capacity for abuse and misuse, require caution and vigilance.
For most people who become addicted to opioids, their first exposure will be through a lawful prescription that was written for a medical purpose. We know that a percentage of people who are exposed to opioids in the medical setting will become long-term users. Some 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 such as heroin and unlawfully made fentanyl.
Addressing this crisis will require concerted action by a number of actors in federal, state, and local government, as well as by partners outside of governmental. FDA has an important role to play.
For example, we’re issuing guidance to encourage the development of therapies to treat opioid addiction, and we’re taking additional steps to encourage the more widespread use of existing, safe and effective, FDA approved therapies to help combat addiction.
We’ve expanded the requirement that opioid manufacturers make training available to prescribers, to apply it not just to extended release, long acting opioids; but also to immediate release products. And we’re considering whether the requirements should be further modified, such as to make appropriate training for prescribers mandatory.
In addition, we’re issuing guidance and taking other actions to encourage manufacturers to develop opioids that have properties that make them harder to abuse, as well as new products that could be used as non-addictive alternatives in the treatment of pain.
And we’re looking carefully at how FDA balances the risks and benefits of opioids when making approval decisions—or when deciding whether we believe a drug should be withdrawn from the market.
But ultimately, everyone involved in making opioids available must recognize that they have a special responsibility to serve as good stewards of these products given all the risks. Given the risks of addiction, of abuse, and misuse that’s devastating American families, opioids need to be promoted responsibly, prescribed appropriately, and manufactured and distributed with close adherence to the law.
There are many good actors who take these responsibilities seriously. They recognize the need for good stewardship of these drugs.
But there are also bad actors that see addiction as an opportunity for profit. Or who are willing to cut corners or take risks in seeking profit, that exacerbate known dangers without regard to the human cost.
When irresponsible behavior, or affirmative misconduct, implicates the laws that FDA’s charged with enforcing, we won’t hesitate to intervene.
This means both using our regulatory authorities and also pursuing criminal charges, where appropriate. Given the scope of the crisis today, we must take bold action to protect the public health, to disrupt ongoing misconduct, and to deter future violations.
For example, if it becomes evident that the benefits of a lawfully marketed drug no longer outweigh its risks—including the illicit risks associated with a drug’s abuse and misuse -- then a responsible manufacturer should do the right thing and voluntarily pull the drug. And if the manufacturer fails to act, then FDA will—and must—step in.
Several months ago we asked the manufacturer of reformulated Opana ER, Endo Pharmaceuticals, to withdraw the drug from the market – an action the manufacturer agreed to take voluntarily after FDA stepped in and made the request. Based on data submitted by the manufacturer, it had become evident that there had been a significant shift toward abuse following the drug’s reformulation, and that abuse was associated with significant public health consequences, including an outbreak of HIV and Hepatitis C.
In this case, an advisory committee supported FDA’s request, and FDA stepped in and asked the company to withdraw the drug based on intolerable risks that were known to Endo at the time. I’m pleased to say that once we made this request, the manufacturer agreed to remove its drug from the market voluntarily.
While we hope that most manufacturers will act responsibly and take such action as soon as it is warranted, we also realize that this will not always be the case. FDA will continue to monitor the risks posed by opioids and other lawful drugs. We’ll step in when needed to make sure that, when the evidence shows that their benefits no longer outweigh their known risks; drugs are properly taken off the market.
FDA also has been taking aggressive steps to identify and disrupt affirmative misconduct, and to pursue appropriate criminal penalties, as warranted. Thanks in significant part to the dedicated work of the special agents, analysts, and other staff at OCI; we’ve helped to bring a number of important criminal enforcement actions in recent months.
I’d like to focus for a moment on some of these actions, as well as some of what we’re doing to build our capacity to disrupt misconduct going forward. Just a few weeks ago, a criminal investigation conducted by OCI and our law enforcement partners led to the arrest of the founder and majority owner of a pharmaceutical company, Insys Therapeutics, for alleged misconduct that fueled the opioid epidemic.
He’s charged with conspiring to pay bribes and kickbacks to health care practitioners to induce them to prescribe a powerful opioid—a fentanyl spray intended for certain cancer patients—to large numbers of patients who did not need the drug, including many patients who did not even have cancer. It’s further alleged that he conspired to defraud insurers into paying for the drug when it was prescribed inappropriately.
Through criminal enforcement, we’re making clear that FDA will not tolerate these kinds of marketing practices.
FDA will aggressively pursue those who are willing to profit by fueling addiction through fraud, and we’ll continue to work with our partners in law enforcement to bring charges in appropriate cases.
FDA also is working with our partners to identify and build cases against individuals who tamper with opioids at pharmacies, hospitals, and other points of care. These are individuals who steal opioids for illicit distribution and use, then pass off fake, non-opioid substances to the patients who actually need them. Such misconduct endangers not only the patients who receive spurious drugs instead of the pain treatments they need, but also those who obtain the diverted opioids.
Enforcement in this area is a high priority for FDA. In multiple cases, individuals have been indicted, pled guilty, or been sentenced.
FDA has been active in disrupting criminal actors involved in making and distributing counterfeit opioid products through illicit channels.
Earlier this year, for example, an FDA criminal investigation helped bring about the indictment of half a dozen individuals who allegedly produced fake prescription drugs out of fentanyl, then sold these dangerous, counterfeit opioids across the country through an illegal online store. Such criminal enterprises fuel the opioid crisis in the most dangerous of ways. It’s one of our highest priorities to disrupt them and to help bring the individuals behind them to justice.
These are just a few examples of how FDA’s enforcement actions have been geared at stopping—and punishing—misconduct that worsens the opioid epidemic.
In addition to these examples, FDA also is announcing today that we are taking further action relating to a botanical substance known as kratom.
This product has been shown to have similar effects to opioids. It carries risks of abuse, addiction, and death. Consumers who are using kratom to battle pain or fight addiction, despite, no reliable evidence to support the use of kratom as a treatment for opioid use disorder, may be unwittingly become addicted or put themselves in harm’s way. We’re aware of reports of 36 deaths associated with the use of kratom-containing products, in addition to hundreds of calls to poison control centers each year.
In the face of these risks, FDA must be proactive in protecting the public health. FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. For example, we’re using import alerts and other authorities we have to stop foreign, unapproved and misbranded drugs at the border to actively prevent shipments of kratom from entering the U.S. and, today, we’re publicly warning consumers not to use kratom based on FDA’s mounting concerns regarding risks associated with its use.
We’ve used our authorities to detain hundreds of shipments of kratom at the international mail facilities, and to conduct seizures of kratom. And we’re working with our partners at the Drug Enforcement Administration to further evaluate the product; to determine how it should be scheduled.
These and other regulatory and enforcement actions are important steps in confronting the opioid crisis. But given the scope of this crisis, we must do more. And to do more, it’s crucial that we build upon our capacity to detect and disrupt the flood of illegal opioids, kratom, and other products that are being imported through the international mail facilities. More than 340 million packages reach the U.S. every year.
Given that massive volume, it’s estimated that only a small percentage of the illicit drugs smuggled through the IMFs are being intercepted.
We must do better.
To that end, I’ve worked with Mel Plaisier and the leadership of the Office of Regulatory Affairs to devise an Enforcement Operations Work Plan focused on preventing the import of unapproved drugs.
As part of this Work Plan, we’re working to increase FDA resources devoted to these efforts. Using existing resources, we’ve already almost tripled 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 double the number of port of entry special agents that OCI maintains from 6 to 12 FTEs.
In addition, we’ll increase OCI’s Cybercrime Investigations Unit, Strategic Intelligence Unit, and Intelligence Analysis Branch from 11 to 21 FTEs. And, to support the additional work that we expect our increased efforts at the border will generate, we’ll add five additional laboratory analysts at FDA’s Forensic Chemistry Center, as well as new equipment in both the IMFs and the laboratory.
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. To do these things, we’re working closely with our partners at the U.S. Customs and Border Protection as part of a new working group that we’ve set in motion. We hope to have much more to say soon about steps we can take to increase the scope of our oversight at the points of entry for illegal narcotics.
The opioid crisis has reached a point that calls for a dramatic response. I’m committed to working with all of you to help FDA step up our efforts and take aggressive enforcement and regulatory actions.
OCI plays a vital role, not just in addressing the opioid crisis, but also in ensuring compliance across the range of our program areas. It’s an honor to be with you here today, and I look forward to meeting many of you.