Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and C

FDA Statement

• For Immediate Release: October 24, 2018
• Statement From: Scott Gottlieb, M.D.

Today, we took an important step forward in combatting the devastating crisis of opioid addiction plaguing our nation. The President signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, bipartisan legislation that builds on the notable progress we’ve made addressing the human and financial toll of the opioid crisis. The new legislation grants the FDA additional authorities that we believe will meaningfully advance our efforts, and the agency will take immediate steps to implement this legislation in a way that achieves Congress’ and the President’s goals to reduce the scope of the crisis.

Over the past 18 months, we’ve taken a range of new steps as part of a comprehensive approach, in concert with the steps that the Secretary of Health and Human Services has outlined to confront this crisis. Our work falls into four main buckets. First, our efforts to decrease exposure to opioids as a way to prevent new addiction; second, advancing innovation in pain medicines that don’t have the same risks as opioids; third, the development and use of better treatments to help those with opioid use disorder; and fourth, increasing our enforcement and interdiction work aimed at illicit drugs such as fentanyl, especially when it comes to products being shipped illegally through the international mail facilities (IMFs).

This legislation gives us important new tools to work more effectively across all four broad domains.

Take our work aimed at interdiction and enforcement. One of the new authorities being granted to the FDA will allow us to more efficiently stop illegal, illicit, unapproved, counterfeit and potentially dangerous drugs from entering the U.S. through the IMFs. Given the volume of mail, the increasing sophistication of bad actors, and the amount of time it takes to inspect packages, the risks that illegal and dangerous drugs will get into the hands of unknowing consumers have grown significantly. Tens of millions of packages are estimated to contain FDA-regulated products. A surprisingly high percentage of those products are illegal. In fact, in fiscal year (FY) 2017, 86 percent of the packages that the FDA reviewed contained illegal, illicit, unapproved, counterfeit and potentially dangerous drugs. These products come in all different shapes and forms – some with sophisticated packaging and others in nondescript plastic bags.

One of the other ways the FDA is working to help combat the problem of dangerous drugs entering the U.S. is through criminal investigations conducted by the agency’s Office of Criminal Investigations (OCI). OCI special agents assigned to the IMFs work closely with U.S. Customs and Border Protection and FDA regulatory staff, which identify and refer suspect shipments, and with the U.S. Department of Justice, which brings criminal cases to prosecution. In FY 2017, OCI opened 339 port of entry (POE) investigations and in FY 2018 opened 220. These investigations have proven to be successful in holding criminals accountable. In FY 2017, overall POE investigations resulted in 115 arrests or prosecutions, more than 60 guilty pleas and more than 80 convictions. In FY 2018, more than 120 arrests or prosecutions, more than 80 guilty pleas and 90 convictions have resulted from POE investigations. All of this work at the IMFs is in addition to OCI’s continued efforts to protect the public health through their engagement with domestic entities.

OCI has also selectively targeted the operations of international criminal groups, both public and on the darknet, and will continue to deploy and dedicate additional frontline and headquarters level resources to address the problem of illicit drugs entering the U.S. In support of this mission, the FDA is expanding OCI’s international network through postings of special agents within U.S. Embassies in strategic countries, and is further developing viable international partnerships, all with the overarching goal of disrupting the illicit movement of all FDA-regulated products. And we’ll continue to focus additional criminal enforcement resources to protect American consumers from illegal, and potentially dangerous, products. These are important successes, but we also expect our ability to take action to improve as we implement these new authorities.

Because of the volume of packages at the IMFs, we can only inspect a small percentage of potentially violative items. The new authorities will allow us to sharply improve our efficiency in the IMFs, expanding our ability to conduct our oversight work. For example, it will now be easier for FDA to detain, refuse and destroy unlabeled and undeclared imported products that are found to contain active ingredients or analogues of active ingredients that are in FDA-approved drugs. This new authority will allow us to much more quickly remove these potentially dangerous drug products from the supply chain.

Toward these same goals, the FDA will now be able to bring actions to debar those who have been convicted of a felony involving illegal importation of drugs or who have engaged in a pattern of importing certain adulterated or misbranded drugs for commercial sale. Once debarred, the FDA can prohibit all future drug importation by that entity, which means that bad actors can’t simply re-open their business under a different name and continue their illegal practices, as they do today. And law enforcement will also now be able to take action against debarred entities that that try to import drugs and against others who do so with the help of debarred entities.

The new law also gives the FDA the authority to issue a mandatory recall order for any controlled substance if there is a reasonable probability that the controlled substance would cause serious adverse health consequences or death. Previously, the recall of these types of drugs could only be done on a voluntary basis.

The legislation will also help us advance efforts to reduce exposure to opioids as a way to lower the rate of new addiction. We know that many people who become addicted to opioids will become medically addicted. Their first exposure to an opioid will typically be from a prescription drug used in a medical setting. By taking additional steps to ensure that people who are prescribed opioids are clearly indicated for these drugs – and that the doses that are dispensed comport closely with the clinical purpose for the prescription – we can reduce exposure to opioids and lower the rate of new addiction.

Toward these ends, the new legislation will allow the FDA to require certain packaging, such as unit dose blister packs, for opioids and other drugs that pose a risk of abuse or overdose. The convenience of this kind of packaging could encourage prescribers to opt for shorter durations of use, thereby limiting the number of opioids dispensed to patients. In these settings, the doses dispensed in the packs could be designed to align with evidence-based recommendations on what the proper dosing should be for common indications. These packs could then become the default option for more post procedure uses and could discourage physicians from prescribing long durations of use in situations where the evidence shows that short durations are clinically appropriate. It could reduce the number of 30-day prescriptions that are still too common. Ultimately, this approach could reduce the overall number of drugs in circulation and potentially lower the rate of new opioid addiction. It could also address the problem of excess supply, leading to fewer pills left in medicine cabinets that could be inappropriately accessed by family members, including children.

The new legislation also gives the FDA the authority to require that opioids be dispensed with a mail-back pouch or other safe disposal option. This will help get unused medications out of medicine cabinets and is another step afforded by the legislation that can help reduce excess supply that can create a risk for abuse, misuse, and addiction.

To further advance these goals of rationalized prescribing – and help reduce the rate of over-prescribing of opioids – the new law also supports our current actions to promote the development of evidence-based opioid prescribing guidelines for treating acute pain resulting from specific conditions or procedures. To support more rational prescribing practices, the FDA recently awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of such guidelines. As part of this work, NASEM will scan the landscape of existing opioid analgesic prescribing guidelines; examine how these guidelines were developed and any potential gaps in evidence for those guidelines; as well as outline the research needed to generate that additional evidence.

Finally, as a general matter, the FDA has been very vocal about our support of developing drugs to treat pain that are not addictive, as well as the need to better understand the safety and efficacy profile of existing opioids, particularly their use for chronic pain over time. The SUPPORT Act provides new authority that will help us advance our understanding of opioid pain medicines by clarifying the FDA’s authority to require post-market studies on the efficacy of drugs over time under certain circumstances. For example, despite the prevalence of opioid analgesics use to treat chronic pain, there are limited data on the long-term efficacy of opioid analgesics, and whether the long-term use increases the likelihood of addiction, as well as the overall place of opioids in the long-term treatment of pain. More research is needed to fully understand this question.

The new authorities granted to the FDA today will allow the agency to build on the important work we recently outlined and are currently undertaking to change the trajectory of this crisis. We remain committed to using our regulatory authority to address this crisis. And we’re grateful for the important, additional tools that are being provided to the agency to help us accomplish this vital work.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.