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.

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

In an effort to combat the growing epidemic of prescription drug and heroin abuse, the FBI and DEA have released “Chasing the Dragon: The Life of an Opiate Addict,” a documentary aimed at educating students and young adults about the dangers of addiction.

Note: 2019 dates for poster contest have not yet been announced.

Teens in grades 7-12 are invited to create and submit a poster that focuses on the consequences of using heroin and/or misuse of prescription opioids. Posters should be 24” x 36” and should be submitted, via mail or in person, to the FBI, Cleveland Division Field Office, 1501 Lakeside Avenue, Cleveland, Ohio 44114, attn: Community Outreach Specialist, by 5:00 p.m. on March 9, 2018.

More than 400 superintendents/school principals in our area received informational packets regarding the Chasing the Dragon poster contest in an effort to help us and our partners spread the word.

Alumni of the FBI Future Agents in Training program will judge the submitted posters and announce the winners. Prize money is being provided by the FBI Cleveland Citizens Academy Foundation, Robby’s Voice, Mr. and Mrs. Bob Brandt, Westshore Enforcement Bureau, and Mr. James Watson. Winning posters are likely to be displayed in public venues upon the conclusion of the contest.

Students wishing to create and submit a poster may contact FBI Community Outreach Specialist Tamara Larkin at tmlarkin@fbi.gov for additional information and an entry form.

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.

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