HHS Releases New Guidelines for Administering Buprenorphine

Last week, the U.S. Department of Health and Human Services (HHS) released the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder to expand access to buprenorphine by removing some of the barriers associated with obtaining a waiver to prescribe buprenorphine. Under the new guidelines, prescribers are still required obtain a Controlled Substances Act waiver by sending notice to Substance Abuse and Mental Health Services Administration (SAMHSA) of their intent to prescribe buprenorphine. However, the guidelines eliminate the training requirements for eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives who want to treat patients with buprenorphine. This announcement follows a push from Senators Maggie Hassan (D-NH) and Lisa Murkowski (R-AK), and Representatives Paul Tonko (D-NY-20), Antonio Delgado (D-NY-18), Anthony Gonzalez (R-OH-16) and Michael Turner (R-OH-10) urging the Biden Administration to remove requirements to prescribing buprenorphine. In a press release, Office of National Drug Control Policy Acting Director Regina LaBelle said, “removing barriers to quality treatment is a top policy priority for the Biden-Harris Administration. Addiction treatment should be a routine part of healthcare, and this new guideline will make access to quality treatment for opioid use disorder more accessible. The guideline is another important step forward in our efforts to bend the curve of the overdose and addiction epidemic.”

Articles & Resources

HHS – HHS Releases New Buprenorphine Practice Guidelines, Expanding Access to Treatment for Opioid Use Disorder

Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder

FDA Approves Higher Dose of Naloxone Nasal Spray

The Food and Drug Administration recently announced the approval of a naloxone hydrochloride nasal spray product that delivers 8 milligrams of naloxone to treat opioid overdoses. The FDA had previously approved naloxone nasal spray products that deliver 2 milligrams and 4 milligrams of naloxone. The recent approval is one of many steps the FDA has implemented to improve the availability and access to naloxone over the past several years, including extending the shelf life of naloxone nasal spray to 36 months, making it easier for manufacturers to develop and seek approval for over-the-counter naloxone, and requiring drug manufacturers to include recommendations about naloxone in the prescribing information of opioid pain relievers and opioid use disorder treatment medication. In a press release, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said, “today’s action meets another critical need in combatting opioid overdose. Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most.”

Articles & Resources

FDA – FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose

President Biden Nominates Dr. Miriam E. Delphin-Rittmon to Lead SAMHSA

President Biden has nominated Dr. Miriam E. Delphin-Rittmon to serve as Assistant Secretary for mental health and substance use for the Department of Health and Human Services (HHS) and lead the Substance Abuse and Mental Health Services Administration (SAMHSA). Dr. Delphin-Rittmon, who currently serves as Commissioner for the Connecticut Department of Mental Health and Addiction Services, previously served as a Senior Advisor to the Administrator of SAMHSA in 2014. In a press release, Dr. Delphin-Rittmon said, “if confirmed, I look forward to joining the Biden-Harris administration to address the behavioral health of the nation during this challenging and transformative time.”

Articles & Resources

The White House – President Biden Announces Six Key Administration Nominations

Governor Ned Lamont – Governor Lamont Congratulates Commissioner Delphin-Rittmon on Nomination by President Biden as Assistant Secretary for Mental Health and Substance Use

DEA Launches Initiative to Reduce the Flow of Fentanyl into the United States

The Drug Enforcement Administration (DEA) announced Project Wave, an initiative aimed at disrupting the flow of fentanyl into the United States, reducing drug trafficking and crimes associated with fentanyl, and reducing the demand for fentanyl products. The initiative will focus on interdiction, enforcement, and outreach efforts around the Southwest U.S. border and will utilize artificial intelligence to target transnational activities of drug suppliers and criminal organizations in Mexico. The eleven DEA divisions participating the initiative include Phoenix, New York, San Diego, New England, Los Angeles, Chicago, Detroit, St. Louis, San Francisco, Houston, and El Paso. In a press release, DEA Acting Administrator D. Christopher Evans said, “while a major entry point for fentanyl is the Southwest border, the cartels are spreading their poison into communities across the Nation. Through this initiative, we’re tackling a very real public health, public safety, and national security threat, identifying the most egregious street-level networks in our communities and working our way up through the supply chain.”

Articles & Resources

DEA – DEA Launches Project Wave Breaker to Stop Flood of Deadly Fentanyl

Three Measures Introduced Requiring Actions by FDA to Address the Opioid Epidemic

Congressional members introduced three pieces of legislation that would require the Food and Drug Administration (FDA) to take steps to address the opioid epidemic. The Changing the Culture of the FDA Act, introduced by Senator Joe Manchin (D-WV), would require the FDA to amend its mission statement to include specific language on the FDA’s responsibility for protecting public health by considering addiction and overdose deaths when regulating opioids. Senator Manchin also reintroduced the Protecting Americans from Dangerous Opioids Act, which would require that if FDA approves an opioid drug application, the agency should revoke approval for an opioid drug that was previously approved. The bill also requires that FDA prioritize revoking non-abuse deterrent opioids and consider the public health impact of the drug being on the market. Senator Manchin, along with Senators Shelley Moore Capito (R-WV) and Angus King (I-ME), also introduced the FDA Accountability for Public Safety Act, which would require that new opioid products and opioid products seeking expanded labeling are reviewed by an advisory committee before FDA can make a decision on approvals and would require FDA to submit a report on patient safety for all approvals that went against advisory committee recommendations.

Articles & Resources

Senator Joe Manchin – Manchin Bill to Change FDA Culture, Address Role in Drug Epidemic

Changing the Culture of the FDA Act

Senator Joe Manchin – Manchin Reintroduces Bill to Protect Americans from Dangerous Opioids

Protecting Americans from Dangerous Opioids Act

Senator Shelley Moore – Capito, Manchin, King Introduce Bill to Prioritize Public Safety When FDA Approves New Opioids

FDA Accountability for Public Safety Act

Companion Legislation to STOP Fentanyl Act Introduced in the Senate

Last week, Senators Ed Markey (D-MA), Elizabeth Warren (D-MA), Sheldon Whitehouse (D-RI), Tammy Baldwin (D-WI), and Cory Booker (D-NJ) introduced the Support, Treatment, and Overdose Prevention (STOP) of Fentanyl Act, which aims to expand research and education efforts to detect and monitor fentanyl, enhance overdose prevention interventions, expand access to substance use disorder treatment programs, increase public health trainings for law enforcement, and increase synthetic drug surveillance. Representatives Annie Kuster (D-NH-02) and Lisa Blunt Rochester (D-DE-AL) introduced companion legislation in the House in April. In a press release, Senator Whitehouse said “illicit fentanyl is a relentless, deadly force at the center of the opioid crisis. We need to spread the word on how to fight it, deploy proven treatments and support to the front lines, and carefully track what’s working. Comprehensive approaches like this one, alongside other successful opioid measures like my CARA legislation, can give us the upper hand in the battle against opioids.” The bill has been endorsed by the Drug Policy Alliance and the American Society for Addiction Medicine.

Articles & Resources

Senator Ed Markey – Senators Markey, Warren, Whitehouse, Baldwin, and Booker Introduce Legislation to Enhance the Public Health Response to Illicit Fentanyl

STOP Fentanyl Act

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Articles & Resources

American Hospital Association – Chicago hospital, patients benefit from creation of OUD treatment program

BusinessWire – AmeriHealth Caritas District of Columbia Launches New Payment Model to Support Fully Integrated Treatment Strategies for Addiction Recovery

Chicago Tribune – Helping jail inmates kick an opioid addiction helps us all

Drug and Alcohol Dependence – Pharmacy-related buprenorphine access barriers: An audit of pharmacies in counties with a high opioid overdose burden

EurekAlert! – Pain patients and healthcare providers want CDC opioid guideline revoked

Health Affairs – Addiction Should Be Treated, Not Penalized

Kaiser Health News – Doctors More Likely to Prescribe Opioids to Covid ‘Long Haulers,’ Raising Addiction Fears

Law360 – 3 Firms Give Back $1M From Purdue Ch. 11 Fees

Law360 – 5 Key Details As Clock Ticks Down To Opioid MDL’s 1st Trial

Law360 – Bankruptcy Watchdog Bares Teeth At BigLaw In Purdue Ch. 11

Law360 – Opioid Ad Blitz Targeted Not Just Docs But Insurers: J&J Rep

NPR – Opioid Overdose: Four Things We Can Do Today to Stop Senseless Deaths

Oregon Health and Science University – One in five pharmacies blocks access to key medication to treat addiction

Otolaryngology: Head and Neck Surgery – Clinical Practice Guideline: Opioid Prescribing for Analgesia After Common Otolaryngology Operations Executive Summary

Representative Bill Pascrell – Pascrell Leads $10 Million Funding Request for Alternatives to Opioids Program

Senator Shelley Moore Capito – Capito, Manchin Announce Funding for Hepatitis Surveillance, Infectious Disease Consequences of Opioids

STAT – Needed: an Operation Warp Speed for the opioid epidemic

The Daily Northwestern – Northwestern Medicine study finds over 25 percent increase in opioid overdoses in Cook County

The Daily Pennsylvanian – Spike in fatal overdoses in Philadelphia impacts Black and Latinx residents most

The Hill – Biden can send signal of hope for people struggling during the opioid crisis

The Philadelphia Inquirer – Addiction treatment providers in Pennsylvania face little state scrutiny despite harm to clients

The Wall Street Journal – Drugmakers Accused of Causing Opioid Addiction in Trial

The Washington Post – Follow The Post’s investigation of the opioid epidemic

U.S. Attorney’s Office for the District of New Jersey – Ten Members and Associates of ‘Uptop’ Street Gang Charged in Drug Trafficking Conspiracy

U.S. Attorney’s Office for the Middle District of Florida – Cape Coral Man Sentenced To Ten Years In Prison For Distributing Fentanyl

U.S. Attorney’s Office for the Middle District of Florida – Fentanyl Dealer Pleads Guilty To Distributing Narcotics Resulting In Death

University of Michigan – Treating dental pain with opioids linked to higher risk of overdose in patients, family members

Vanderbilt University Medical Center – Study finds increased risk of serious opioid events in mothers, regardless of dose

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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