For Immediate Release: October 24, 2019 Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs - Food and Drug Administration Norman E. "Ned" Sharpless MD

Addressing the opioid crisis continues to be one of the FDA’s top public health priorities. While it is encouraging to see that, according to provisional data, total drug overdose deaths in the United States dropped 5.1% from 2017 to 2018 – the first decrease in more than two decades – we still have much work to do as deaths from drug overdoses remain at historically high levels.

One focus of the FDA’s work over the past year has been implementing the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), bipartisan legislation passed on October 24, 2018, which provided the agency new authorities to advance our efforts to confront the opioid crisis. On this one-year anniversary, I am pleased to share that we have taken the following actions to fulfill the requirements of various sections of the SUPPORT Act:

Clarifying FDA regulation of non-addictive pain products (Section 3001): Opioid analgesic sparing includes using non-opioid drugs to provide analgesia (pain relief) that would otherwise be provided with opioids. This can reduce patient exposure to opioids as well as the number of leftover opioids available for abuse or misuse in the community. To gain input on this issue, the agency held an advisory committee meeting to discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. In addition, the FDA issued the draft guidance, Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework, which describes the application of the benefit-risk assessment framework that the agency uses in evaluating applications for opioid analgesic drugs and summarizes the information that can be supplied by opioid analgesic drug applicants to assist the agency with its benefit-risk assessment. The guidance makes clear that the FDA considers the broader public health effects of these products as part of its benefit-risk assessment. The FDA also held a public meeting to gain feedback on, and further discuss, the agency’s benefit-risk assessment of opioid analgesics, including the manner in which risks of misuse and abuse of these products factor into that assessment. The agency also requested input on potential new preapproval incentives aimed at fostering the development of new therapies to treat pain or addiction.

Opioid analgesic sparing includes using non-opioid drugs to provide analgesia (pain relief) that would otherwise be provided with opioids. This can reduce patient exposure to opioids as well as the number of leftover opioids available for abuse or misuse in the community. To gain input on this issue, the agency held an advisory committee meeting to discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. In addition, the FDA issued the draft guidance, Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework, which describes the application of the benefit-risk assessment framework that the agency uses in evaluating applications for opioid analgesic drugs and summarizes the information that can be supplied by opioid analgesic drug applicants to assist the agency with its benefit-risk assessment. The guidance makes clear that the FDA considers the broader public health effects of these products as part of its benefit-risk assessment. The FDA also held a public meeting to gain feedback on, and further discuss, the agency’s benefit-risk assessment of opioid analgesics, including the manner in which risks of misuse and abuse of these products factor into that assessment. The agency also requested input on potential new preapproval incentives aimed at fostering the development of new therapies to treat pain or addiction. Evidence-based opioid analgesic prescribing guidelines and report (Section 3002): The FDA is working to submit a report to Congress on how the agency will utilize evidence-based opioid analgesic prescribing guidelines to protect the public health and a description of the public health need with respect to each such indication-specific treatment guideline. To inform the development of evidence-based guidelines that support more appropriate prescribing practices, the FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of such guidelines. We expect to receive NASEM’s report in early 2020.

The FDA is working to submit a report to Congress on how the agency will utilize evidence-based opioid analgesic prescribing guidelines to protect the public health and a description of the public health need with respect to each such indication-specific treatment guideline. To inform the development of evidence-based guidelines that support more appropriate prescribing practices, the FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of such guidelines. We expect to receive NASEM’s report in early 2020. Strengthening FDA and U.S. Customs and Border Protection (CBP) coordination and capacity (Section 3014): The FDA, in coordination with CBP and the U.S. Postal Service, submitted a report to Congress on enhancements to improve the screening of parcels at international mail facilities (IMFs), including facility upgrades, improved capacity and innovative technology. The FDA and CBP signed a Letter of Intent to establish an outline of strategies for advanced collaboration between the agencies that will be carried out through a series of separate written agreements. These agreements are expected to include procedures to enhance information sharing and operations, including the establishment of a list of controlled substances that are imported via international mail and which agency will retain primary interdiction responsibility. Three FDA/CBP work groups to implement the Letter of Intent have been established in the following areas: Collaboration at Ports of Entry, On-Site Laboratory and Scientific Services, and Shared Facilities and Space at the IMFs.

The FDA, in coordination with CBP and the U.S. Postal Service, submitted a report to Congress on enhancements to improve the screening of parcels at international mail facilities (IMFs), including facility upgrades, improved capacity and innovative technology. The FDA and CBP signed a Letter of Intent to establish an outline of strategies for advanced collaboration between the agencies that will be carried out through a series of separate written agreements. These agreements are expected to include procedures to enhance information sharing and operations, including the establishment of a list of controlled substances that are imported via international mail and which agency will retain primary interdiction responsibility. Three FDA/CBP work groups to implement the Letter of Intent have been established in the following areas: Collaboration at Ports of Entry, On-Site Laboratory and Scientific Services, and Shared Facilities and Space at the IMFs. Restricting entrance of illicit drugs (Section 3022): Since implementation of the law, the FDA has identified more than 9,800 products processed through all IMFs as drugs because they contain an ingredient which presents a significant public health concern. Of these, more than 9,000 drugs have either been refused and destroyed or are being processed for administrative destruction, reflecting a 92% destruction rate for these products. The FDA also submitted a report to Congress about the list of controlled substances that the agency will refer to CBP for disposition under the Controlled Substances Act. Additionally, the FDA has issued several notices of debarment for a felony conviction involving the illegal importation of a drug. The first debarment order is currently being processed under this new authority.

Since implementation of the law, the FDA has identified more than 9,800 products processed through all IMFs as drugs because they contain an ingredient which presents a significant public health concern. Of these, more than 9,000 drugs have either been refused and destroyed or are being processed for administrative destruction, reflecting a 92% destruction rate for these products. The FDA also submitted a report to Congress about the list of controlled substances that the agency will refer to CBP for disposition under the Controlled Substances Act. Additionally, the FDA has issued several notices of debarment for a felony conviction involving the illegal importation of a drug. The first debarment order is currently being processed under this new authority. Safety-enhancing packaging and disposal (Section 3032): The FDA opened a public docket to solicit feedback on potentially requiring that certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging. This could reduce the amount of unused opioid analgesics, reducing opportunities for misuse and abuse by patients and others. The agency is currently evaluating the public comments submitted to the docket and gathering additional stakeholder input to determine next steps.

The FDA opened a public docket to solicit feedback on potentially requiring that certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging. This could reduce the amount of unused opioid analgesics, reducing opportunities for misuse and abuse by patients and others. The agency is currently evaluating the public comments submitted to the docket and gathering additional stakeholder input to determine next steps. Clarifying FDA postmarket authorities (Section 3041): The agency issued the revised draft guidance, Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act. The SUPPORT Act required the issuance of guidance regarding the circumstances under which the FDA may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. This revised draft guidance addresses these topics, among other things, and further provides examples of when a postmarketing study or clinical trial may be required to further assess whether a potential failure of expected pharmacological action, including reduced effectiveness, may result in a serious adverse drug experience.

The agency issued the revised draft guidance, Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act. The SUPPORT Act required the issuance of guidance regarding the circumstances under which the FDA may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. This revised draft guidance addresses these topics, among other things, and further provides examples of when a postmarketing study or clinical trial may be required to further assess whether a potential failure of expected pharmacological action, including reduced effectiveness, may result in a serious adverse drug experience. Study on abuse-deterrent opioid formulations access barriers under Medicare (Section 6012): The FDA, in coordination with the Centers for Medicare and Medicaid Services, is working to submit a report to Congress on the adequacy of access to abuse-deterrent formulations (ADFs) of opioid analgesics under Medicare and the effectiveness of ADFs in reducing abuse and misuse.

Additionally, with the authorities provided by the SUPPORT Act, the FDA is taking new steps to promote the development of drugs to treat pain that are not addictive. To advance these goals, we are developing draft guidances addressing important issues related to the development of non-opioid drugs for use in the treatment of acute and chronic pain. We are also considering whether to use the new SUPPORT Act authority over packaging and disposal to require that opioids be dispensed with disposal technologies (such as mail-back pouches) to help get unused medications out of medicine cabinets.

The FDA is actively revising our regulatory procedures to implement new authority provided by the SUPPORT Act to issue a mandatory recall for any controlled substance if there is a reasonable likelihood that the drug would cause serious adverse health consequences or death.

While we are proud of these accomplishments, we know that there is still more to do. We will continue to implement the SUPPORT Act to build upon our efforts and adapt our responses to confront the changing nature of the opioid crisis. The FDA remains committed to addressing this national crisis on all fronts, with a continued focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies; and taking action against those who contribute to the illegal importation and sale of opioid products. The agency will continue to use its regulatory authority to address this crisis, and the additional tools that the SUPPORT Act provides are helping 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.

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