FDA to Launch New Controlled Substances Program, Indicates Forthcoming Opioid Data Warehouse within Drug Center

The FDA took additional steps this week to further advance the agency’s response to the evolving drug abuse epidemic that continues to claim tens of thousands of lives per year. On Wednesday, in a series of remarks, FDA Drug Center Deputy Director Douglas Throckmorton announced the formation of a Controlled Substances Program (CSP) that will be housed within the office of the Drug Center Director, Dr. Janet Woodcock. Dr. Marta Sokolowska, currently the Associate Director for Controlled Substances within CDER, has been tapped to lead the program. Sokolowska will oversee the current Controlled Substances Staff along with the newly formed Controlled Substances Initiative team.

Upon announcement of the new program, Throckmorton said, “The CSP is being established to coordinate [the drug center’s] activities and emerging issues around controlled substances, including prescription opioids, benzodiazepines, and stimulants…The CSP will strengthen the center’s ability to proactively pursue policies and initiatives to prevent or minimize the risks associated with problematic use of controlled substances — and help enable appropriate access to these products for medical use.”

The CSP has been tasked with two key initiatives upon its creation: targeting the evolution of the drug abuse epidemic via rising stimulant abuse rates and creation of an Opioid Data Warehouse. The latter is funded based upon FY2019 allocations towards opioid initiatives. According to Dr. Throckmorton, $20 million of the $47 million total is being directed towards development of a comprehensive analytical warehouse to better inform FDA on current and potential opportunities to combat substance misuse, abuse and diversion. The Opioid Data Warehouse is scheduled to launch next month.

Articles & Resources

Politico – FDA Creates New Controlled Substances Program

Inside Health Policy – FDA Will Launch Its Opioid Data Warehouse in March

Pink Sheet – Opioid ‘Data Warehouse’ Is Part Of US FDA’s New Controlled Substances Program

CDC Research Finds Loose Opioids As Major Factor in Youth Exposure and Ingestion

Research from the Centers for Disease Control and Prevention (CDC) was published in the Journal of Pediatrics last week reviewing a retrospective analysis of activity at poison control centers in Arizona, Florida and Georgia. While not specific to opioids, the research did provide greater insight to the risks of prescription drugs kept either in non-child-resistant packaging or simply left out. Over the duration of the study, it was found that nearly three-quarters of young children impacted by unsupervised access were under two years of age and one-third of exposures were to prescription drugs. Over half (51.5%) of exposures were prescription drugs removed from their original packaging; 42.6% of which is attributed to opioids. While responses to these findings will vary based upon therapeutic class and age of the patient, additional efforts must be taken to ensure sufficient precautions are taken to avoid inadvertent exposure and harms including proper use of child-resistant packaging, unit-dose packaging, and other interventions aimed at securing prescription and OTC products.

Articles & Resources

CDC Newsroom – Adults Unintentionally Make It Easy for Young Children to Eat Dangerous Pills

The Journal of Pediatrics – Circumstances Involved in Unsupervised Solid Dose Medication Exposures Among Young Children

FDA Solicits Feedback on ADF Provider Survey

The FDA this week published notice in the Federal Register of a proposed collection and comment request entitled “Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations.” FDA is seeking feedback from approximately 1,000 healthcare providers around their understanding of ADFs, their application, and potential future efforts related to that therapeutic class.

In the publication, FDA notes, “ADF prescription practices may present opportunities for HCPs to reduce opioid abuse. Conducting a comprehensive evaluation of opioid prescribers’ knowledge, attitudes, perceptions, experiences, and behaviors related to ADFs will help to inform FDA’s approaches to ADFs.” The survey will glean additional information around prescriber’s knowledge, attitude and behaviors related to ADF use.

Comments on the proposed line of questioning are due no later than April 6, 2020.

Articles & Resources

Federal Register – Proposed Collection and Comment Request: Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations

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

New York Times – ‘Get Well or Die’: A State Senator Reveals His Addiction Battle

Bloomberg Government – States Nix $18 Billion Opioid Sellers’ Settlement Offer

Wall Street Journal – 21 States Reject $18 Billion Offer from Drug Wholesalers to Settle Opioid Litigation

ABC News – Ohio County May need Second Morgue to Handle Drug Overdose Deaths, Coroner Says

NPR – Police Offering Drug Recovery Help: ‘We Can’t Arrest Our Way Out Of This Problem’

Law360 – 6th Circuit Halts Nationwide Discovery in Opioid MDL

Pink Sheet –  ‘Abuse-Deterrent’ Opioids May Be Headed For A Terminology Change

Kaiser Health News – No Quick Fix: Missouri Finds Managing Pain Without Opioids Isn’t Fast Or Easy

STAT News – As Opioid Crisis Intensified, Many Family Doctors Found Promotional Pitches Were Very Good

Duluth News Tribune Investigator: Employee Stole Opioids From Nashwauk Patients

PA Governor Newsroom – Wolf Administration Seeks Input from Providers on Barriers to Mental Health and Substance Use Disorder Treatment

Blue Cross Blue Shield of Rhode Island – Peer Recovery Program Leads to Better Treatment Adherence and Lower Healthcare Costs When Coupled with a PCP and Medication-Assisted Treatment

The Journal of Pediatrics – Impact of Office-based Opioid Treatment on Emergency Visits and Hospitalization in Adolescents with Opioid Use Disorder

Journal of the American Medical Association – Availability of Naloxone at Rural Georgia Pharmacies, 2019

U.S. Department of Agriculture – Stakeholder Announcement: USDA Rural Development Designates Rural Health Liaison

U.S. Attorney for the Eastern District of Missouri – Three Local Doctors and Staff/Patients Indicted for Conspiring to Distribute Oxycodone

U.S. Attorney for the Southern District of Georgia – Georgia Pharmacy, Pharmacist Accused in Civil Suit of Unlawfully Dispensing Thousands of Opioids and Other Controlled Substances

U.S. Attorney for the Southern District of Georgia – Pill-Mill Doctor Gets Decades in Prison for Healthcare Fraud, Illegally Dispensing Massive Amounts of Drugs

U.S. Attorney for the Eastern District of Tennessee – Federal Jury Convicts Four Defendants For Operating Knoxville-Area “Pill Mills”

This Week’s Calendar

Both the Senate and House are on recess this week, set to return on Monday and Tuesday, respectively. Should there be any additions to House or Senate schedules or updates with respect to additional events, this information will be made available.

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