Opioid Summit Fact Sheet Issued by White House Summarizes Plans & Accomplishments to Date

COMING TOGETHER TO COMBAT THE OPIOID CRISIS: Today, the White House is hosting an Opioid Summit to discuss the Administration-wide efforts to combat the opioid crisis.

  • The Opioid Summit will include individuals who have been affected by the opioid crisis and addiction- and recovery-focused organizations.
  • Members of President Trump’s Administration will detail the actions they have undertaken to confront the opioid crisis on all possible fronts.
    • The Administration’s efforts to address drug addiction and opioid abuse are focused on education and prevention, treatment and recovery, and law enforcement and interdiction.
  • Panels on the Administration’s efforts to fight back against the opioid crisis will include:
    • Prevention, Treatment, and Recovery, and
    • Law Enforcement and Interdiction.

FIGHTING BACK: President Trump has made clear that his Administration will fight back against the opioid crisis facing our Nation.

  • President Trump has directed actions across the entire executive branch designed to target drug addiction and opioid abuse.
  • President Trump announced on October 26, 2017, that his Administration would declare the opioid crisis a Nationwide Public Health Emergency.
    • The declaration opened up avenues necessary to combatting the opioid crisis.
  • The President’s Commission on Combating Drug Addiction and the Opioid Crisis issued a final report on November 1, 2017, and the Administration has already begun acting on a number of the Commission’s recommendations.

EDUCATION AND PREVENTION: President Trump’s Administration is fighting back against the opioid crisis through education and prevention.

  • The President’s Administration led a national “Take Back Day” which collected 456 tons of expired and unneeded prescription drugs, making it the most successful “Take Back Day” on record.
    • National Prescription Drug Take Back Day provides a means for disposing of prescription drugs while also educating the public about prescription drug abuse.
  • The Department of Veterans Affairs (VA) became the first hospital system to release opioid prescribing rates.  The VA began publicly posting information on opioids dispensed from VA pharmacies, along with VA’s strategies to prescribe these pain medications appropriately.
  • The Food and Drug Administration (FDA) is considering new ways to facilitate appropriate prescribing practices.

TREATMENT AND RECOVERY:  The President’s Administration has taken action to provide more treatment and recovery options for those struggling with opioid addiction.

  • The President’s Budget proposes $3 billion in new funding in 2018 and $10 billion in new funding in 2019 for the Department of Health and Human Services (HHS) to combat the opioid epidemic.
  • The Substance Abuse and Mental Health Service Administration (SAMHSA) and the Federal Trade Commission (FTC) released consumer information that will help individuals seeking treatment for opioid dependence or withdrawal.
  • SAMHSA awarded $485 million State Targeted Response grants in FY 2017 to help States, territories and jurisdictions expand prevention, treatment and recovery support services for individuals with an opioid use disorder.
  • The Centers for Medicare & Medicaid Services (CMS) announced a new policy that gives States more flexibility to enact demonstration projects that include coverage of inpatient or residential addiction treatment programs in facilities not typically covered by Medicaid.
  • FDA approved a new buprenorphine medication-assisted treatment for opioid use disorder that requires monthly treatment, compared to other treatments requiring daily medication.
  • CDC’s Enhanced State Opioid Overdose Surveillance grant program funding went to States to strengthen prevention efforts and better track opioid-related overdoses.
  • CDC also funded Prescription Drug Overdose: Prevention for States grants, a program that provides state health departments with resources and support needed to advance interventions for preventing prescription drug overdoses.
  • The Health Resources and Services Administration is expanding access to substance abuse treatment services through primary care providers in underserved communities.

“Chasing the Dragon: The Life of an Opiate Addict”: FBI & DEA Documentary & Poster Contest

LAW ENFORCEMENT AND INTERDICTION: Under President Trump, Federal law enforcement has fought to curb the illegal importation and distribution of opioids that has helped fuel this epidemic.

  • This week Attorney General Sessions announced the creation of the Prescription Interdiction & Litigation (PIL) Task Force, which will focus on targeting opioid manufacturers and distributors who have contributed to the epidemic.
  • In January, Attorney General Sessions announced a new Joint Criminal Opioid Darknet Enforcement (J-CODE) Team tasked with helping law enforcement disrupt online sales of illicit opioids.
  • The Department of Justice launched a health care fraud crackdown that charged more than 400 defendants, including more than 120 for their role in prescribing and distributing opioids and other narcotics.
  • The Department of Justice secured its first-ever indictments against Chinese fentanyl manufacturers.
  • The President signed the INTERDICT Act on January 10, 2018, authorizing to enhance efforts to detect and interdict the supply of synthetic opioids such as fentanyl that are being illegally imported.

Kratom: FDA Releases Latest Science on Adverse Events

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Additional adverse events associated with kratom use identified

February 6, 2018

Summary

FDA releases adverse events and scientific analysis providing even stronger evidence of kratom compounds’ opioid properties.

Statement

Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health. However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of this product and how it works in the body. Today, we’re providing details of some of the important scientific tools, data and research that have contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.

Notably, we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds’ opioid properties. These kinds of models have become an advanced, common and reliable tool for understanding the behavior of drugs in the body. We also have learned more about deaths that involved kratom use, and have identified additional adverse events related to this product. This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom.

We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.

The FDA’s PHASE model used to assess kratom

Federal agencies need to act quickly to evaluate the abuse potential of newly identified designer street drugs for which limited or no pharmacological data are yet available. This is why the FDA developed the Public Health Assessment via Structural Evaluation (PHASE) methodology – a tool to help us simulate, using 3-D computer technology, how the chemical constituents of a substance (such as the compounds/alkaloids found in kratom) are structured at a molecular level, how they may behave inside the body, and how they can potentially affect the brain. In effect, PHASE uses the molecular structure of a substance to predict its biological function in the body. For example, the modelling platform can simulate how a substance will affect various receptors in the brain based on a product’s chemical structure and its similarity to controlled substances for which data are already available.

Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

Next, our scientists analyzed the chemical structure of these kratom compounds against the software to determine its likely biologic targets. The model predicted that 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors. This model, together with previously available experimental data, confirmed that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (“opioid agonists”).

The new data provides even stronger evidence of kratom compounds’ opioid properties.

The computational model also predicted that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function. The agency has previously warned of the serious side effects associated with kratom including seizures and respiratory depression.

The third aspect of the model is the 3-D image we generate to look at not just where these compounds bind, but how strongly they bind to their biological targets. We found that kratom has a strong bind to mu-opioid receptors, comparable to scheduled opioid drugs.

So what does this body of scientific evidence mean? The FDA relies on this kind of sophisticated model and simulation to supplement its data on how patients react to drugs; often as a way to fully elucidate the biological activity of a new substance. The data from the PHASE model shows us that kratom compounds are predicted to affect the body just like opioids. Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids.

Furthermore, this highlights the power of our computational model-based approach to rapidly assess any newly identified natural or synthetic opioids to respond to a public health emergency.

Kratom Warning: Salmonella Infections Linked to Kratom Products

Learnings from reports of death associated with kratom

We’ve been carefully monitoring the use of kratom for several years, and have placed kratom products on import alert to prevent them from entering the country illegally. We have also conducted several product seizures. These actions were based, in part, on a body of academic research, as well as reports we have received, suggesting harm associated with its use. And we are not alone in our evaluation and our public health concerns. Numerous countries, states and cities have banned kratom from entering their jurisdictions. We described some of this information in a public health advisory in November 2017, in which we urged consumers not to use kratom or any compounds found in the plant.

Now, I’d like to share more information about the tragic reports we have received of additional deaths involving the use of kratom. Looking at the information we have received – including academic research, poison control data, medical examiner reports, social science research and adverse event reports – we now have 44 reported deaths associated with the use of kratom. This is an increase since our November advisory, which noted 36 deaths associated with these products. We’re continuing to review the newly received reports and will release those soon. But it’s important to note that these new reports include information consistent with the previous reports.

Today, we’re releasing the reports of the 36 deaths we referenced in November. These reports underscore the serious and sometimes deadly risks of using kratom and the potential interactions associated with this drug. Overall, many of the cases received could not be fully assessed because of limited information provided; however, one new report of death was of particular concern. This individual had no known historical or toxicologic evidence of opioid use, except for kratom. We’re continuing to investigate this report, but the information we have so far reinforces our concerns about the use of kratom. In addition, a few assessable cases with fatal outcomes raise concern that kratom is being used in combination with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications, like the anti-diarrheal medicine, loperamide. Cases of mixing kratom, other opioids, and other types of medication is extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids.

However, unlike kratom, FDA-approved drugs have undergone extensive review for safety and efficacy, and the agency continuously tracks safety data for emerging safety risks that were previously unknown. So we have better information about the risks associated with these products; and can better inform the public of new safety concerns. For example, in August 2016, the FDA required a class-wide change to drug labeling to help inform health care providers and patients of the serious risks (including respiratory depression, coma and death) associated with the combined use of certain opioid medications and benzodiazepines. In June 2016, the agency also issued a warning that taking significantly high doses of loperamide, including through abuse or misuse of the product to achieve euphoria or self-treat opioid withdrawal, can cause serious heart problems that can lead to death. We also recently took steps to help reduce abuse of loperamide by requesting packaging restrictions for these products sold “over-the-counter.”

Taken in total, the scientific evidence we’ve evaluated about kratom provides a clear picture of the biologic effect of this substance. Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s “just a plant” is shortsighted and dangerous. After all, heroin is an illegal, dangerous, and highly-addictive substance containing the opioid morphine, derived from the seed pod of the various opium poppy plants.

Further, as the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant – it’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms. We recognize that many people have unmet needs when it comes to treating pain or addiction disorders. For individuals seeking treatment for opioid addiction who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider. There are safe and effective, FDA-approved medical therapies available for the treatment of opioid addiction. Combined with psychosocial support, these treatments are effective. Importantly, there are three drugs (buprenorphine, methadone, and naltrexone) approved by the FDA for the treatment of opioid addiction, and the agency is committed to promoting more widespread innovation and access to these treatments to help those suffering from an opioid use disorder transition to lives of sobriety. There are also safer, non-opioid options to treat pain. We recognize that some patients have tried available therapies, and still have unmet medical needs. We’re deeply committed to these patients, and to advancing new, safe and effective options for those suffering from these conditions.

Opioid Cessation Products: FTC, FDA Warn Companies about Marketing & Selling

FTC, SAMHSA also issue fact sheet on how to get the right help for addiction and withdrawal

The Federal Trade Commission and the U.S. Food and Drug Administration (FDA)  posted warning letters to the marketers and distributors of 11 opioid cessation products for illegally marketing products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal.

“Opioid addiction is a serious health epidemic that affects millions of Americans,” said Acting FTC Chairman Maureen K. Ohlhausen. “Individuals and their loved ones who struggle with this disease need real help, not unproven treatments. We will continue to work together with the FDA to address this important issue.”

Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal is a violation of the Federal Food, Drug, and Cosmetic Act. Making unsubstantiated therapeutic claims is also a violation of the Federal Trade Commission Act, which prohibits deceptive advertising.

Also today, the FTC, in coordination with SAMHSA of the U.S. Department of Health and Human Services (HHS), issued a fact sheet to help consumers get real help for opioid addiction or withdrawal, while avoiding products that promise but do not deliver help. The fact sheet has tips that consumers and health practitioners alike can share with those considering help for opioid addiction or withdrawal. Patients receiving FDA-approved medication-assisted treatment cut their risk of death in half, according to SAMHSA.

The FDA and FTC issued joint warning letters to 11 companies for their products: Opiate Freedom Center (Opiate Freedom 5-Pack); U4Life, LLC (Mitadone); CalmSupport, LLC (CalmSupport); TaperAid (TaperAid & TaperAid Complete); Medicus Holistic Alternatives, LLC (Natracet); NutraCore Health Products, LLC (Opiate Detox Pro); Healthy Healing, LLC (Withdrawal Support); Soothedrawal, Inc. (Soothedrawal); Choice Detox Center, Inc. (Nofeel); GUNA, Inc. (GUNA-ADDICT 1); and King Bio, Inc. (AddictaPlex).

The FTC sent four additional warning letters to other marketers of opioid cessation products.

All of the companies use online platforms to make unproven claims about their products’ ability to cure, treat, or prevent a disease. Examples of claims made include:

  • “#1 Selling Opiate Withdrawal Brand”
  • “Imagine a life without the irritability, cravings, restlessness, excitability, exhaustion and discomfort associated with the nightmare of addiction and withdrawal symptoms.”
  • “Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal.”
  • “Break the pain killer habit.”
  • “Relieve Your Symptoms…addiction, withdrawal, cravings.”

The FTC and FDA have requested responses from each of the companies within 15 working days. The companies are directed to inform each agency of the specific actions taken to address each agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.

Health care professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form.The completed form can be submitted online or via fax to 800-FDA-0178.

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.

FDA Needs Public to Report Adverse Events Related to Homeopathic Products

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.

For more information click here.