OxyContin Data Review Finds Limited Evidence in Abuse Reduction

On Thursday and Friday of last week, a joint advisory committee meeting was held to review the Category 4 postmarketing data compiled by Purdue Pharma, manufacturer of extended-release OxyContin. At the core of the discuss was the 2010 reformulation of the drug intended to reduce nasal and intravenous abuse. Having reviewed the long-awaited data, agency scientists were unable to identify any evidence that clearly demonstrated a reduction in overdoses or deaths following the introduction of the reformulated pill.

Compared to earlier iteration of the pill, the 2010 reformulation was able to reduce abuse via snorting and injection while general reductions around overdoses or death were not identified. Purdue data indicated that a dip in prescribing and illicit sales decreased after the reformulation was introduced in 2010 although it is difficult to understand whether that was due to the change itself or other actions to tamp down improper prescribing or a shift in use of illicit narcotics.

Articles & Resources

Associated Press – Experts: Revamped OxyContin Hasn’t Curbed Abuse, Overdose

LINK to FDA Advisory Committee Meeting Announcement and Docket

FDA Issues 17 Warning Letters for Illegal Online Opioid Sales

The FDA announced last Thursday the issuance of 17 warning letters to websites that were found to be illegally advertising and selling prescription opioids via the Internet. In violation of the Federal Food, Drug, and Cosmetic Act, these websites were found to be selling opioids and other controlled substances. Ranging from tramadol to oxycodone, these products were distributed without oversight of a legitimate healthcare provider, often without a prescription or necessary directions for use, placing the end-user at significant risk of addiction or overdose.

In response to the actions taken, FDA Office of Compliance Director Don Ashley noted, “Those who illegally sell opioids online put consumers at risk and undermine the significant strides we have made to combat the opioid crisis…We remain committed to using all available tools to stop the illegal sale of opioids online to help protect consumers from these potentially dangerous products.”

In 2018 and 2019 the agency held Online Opioid Summits that were focused on combatting the threat associated with the sale of such products online with additional action expected later this year.

Articles & Resources

FDA Newsroom – FDA Warns Website Operators Illegally Selling Opioids to Consumers

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

Washington Post – The Opioid Crisis, Already Serious, Has Intensified During Coronavirus Pandemic

STAT News – Pregnancy Poses Challenges for People in Recovery from Substance Use Disorder. COVID-19 is Taxing Their Support System

Health Affairs – Regulating Opioid Supply Through Insurance Coverage

Pediatrics – Medical Use and Misuse of Prescription Opioids in US 12th-Grade Youth: School-Level Correlates

Boston Globe – AG Healy Announces $1.5 Million Grant Program to Expand Opioid Treatment Access for People of Color

The Herald – Worker at Hospital in Rock Hill Charged with Stealing Fentanyl for Her Own Use

Army Times – Opioids, Other Drugs Inadequately Safeguarded by CENTCOM Pharmacies, Investigators Find

Pensacola News Journal – We Must Unite Statewide Efforts to Tackle Drug Abuse

FDA Insights – The Opioid Epidemic and COVID-19 Pandemic (Episode 11)

Federal Register – Information Collection on Value in Opioid Use Disorder Treatment Demonstration

Agency for Healthcare Research and Quality – Treatments for Acute Pain: A Systematic Review (Open for Public Comment Through September 28, 2020)

U.S. Attorney for the District of Nevada – Doctor Indicted For Unlawful Distribution Of Opioid Medications

U.S. Attorney for the Western District of Pennsylvania – VA Hospital Nurse Charged with Using Her Position to Obtain Painkillers

U.S. Attorney for the Eastern District of California – Three Individuals Indicted for Conspiring to Traffic Over 10,000 Fentanyl Pills and 10 Pounds of Methamphetamine and Possessing Firearms in Furtherance of Their Drug Trafficking Crimes

U.S. Attorney for the Eastern District of North Carolina – New Bern Medical Doctor Sentenced for Unlawfully Distributing Oxycodone, Money Laundering and Tax Evasion

U.S. Attorney for the Northern District of Alabama – Fultondale Doctor Sentenced for Unlawful Drug Distribution and Heath Care Fraud and Demopolis Pharmacist Sentenced for Health Care Fraud

This Week’s Calendar

The House and Senate have no opioid-related hearings or events scheduled at this time as they return from their August recess and undertake a brief sprint before Members break for an October recess ahead of the November elections. In the instance that there are any changes to the schedule for this week, we will make additional information available.

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