How FDA Failures Contributed to the Opioid Crisis

Abstract

Over the past 25 years, pharmaceutical companies deceptively promoted opioid use in ways that were often neither safe nor effective, contributing to unprecedented increases in prescribing, opioid use disorder, and deaths by overdose. This article explores regulatory mistakes made by the US Food and Drug Administration (FDA) in approving and labeling new analgesics. By understanding and correcting these mistakes, future public health crises caused by improper pharmaceutical marketing might be prevented.

Industry strategies to market opioids to children and women in the USA: a content analysis of internal industry documents from 1999 to 2017 released in State of Oklahoma v. Purdue Pharma, L.P.et al

“…Due to the delay in releasing documents related to litigation, some of the materials cited in the manuscript date back over two decades, and reveal a pattern of pharmaceutical company behaviour that has remained largely unresolved; the FDA has been criticised by multiple sources for failing to change its regulatory policies to address opioid marketing over this time period. 99 …”

“…Due to the delay in releasing documents related to litigation, some of the materials cited in the manuscript date back over two decades, and reveal a pattern of pharmaceutical company behaviour that has remained largely unresolved; the FDA has been criticised by multiple sources for failing to change its regulatory policies to address opioid marketing over this time period. 99 Recommendations for research Litigation against opioid manufacturers continues, as does the release of new documents identified in legal discovery. Further review and analysis of pharmaceutical industry documents is needed to understand the industry's ongoing marketing strategies, what portions of the population may be targeted, and whether pharmaceutical companies may market other products using similar campaigns, particularly given that FDA regulations remain unchanged.…”

El impacto sobre la salud colectiva de las conductas censurables en la investigación sanitaria

“…Todo acto de corrupción necesita corruptibles, de modo que otros notables actores se articularon en la madeja criminal para avalar, ocultar o secundar los desmanes empresariales. Entre ellos, puede citarse a la Food and Drug Administration (FDA), muchos de cuyos expertos fueron directamente sobornados [28,29] y a la Agencia Antidroga de Estados Unidos (DEA), que desoyó reiteradas advertencias y obstaculizó de modo sistemático la justicia [30].…”

A Demographic and Regional Comparison of Opioid-Related Hospital Visits within Community Type in the United States

“…After this initiative, prescription opioid sales, and subsequent misuse, abuse and addiction, began to rise with opioid-related emergency department (ED) visits and deaths following suit [2]. Opioid use disorders and opioid overdoses have exponentially grown over the past 25 years, mirroring rising levels of opioid prescriptions [3] and increased use of synthetic opioids [4]. Furthermore, current opioid analgesic prescribing practices have been found to lead to increased manifestations of opioid overuse [2,3,[5][6][7][8][9][10][11][12].…”

“…Opioid use disorders and opioid overdoses have exponentially grown over the past 25 years, mirroring rising levels of opioid prescriptions [3] and increased use of synthetic opioids [4]. Furthermore, current opioid analgesic prescribing practices have been found to lead to increased manifestations of opioid overuse [2,3,[5][6][7][8][9][10][11][12].…”