Conference
The Opioid Crisis Isn't Trumped by the COVID-19 Pandemic.
| Title: | The Opioid Crisis Isn't Trumped by the COVID-19 Pandemic. |
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| Authors: | Sillup, George P.1 sillup@sju.edu, Giovenella, Albert2, DeLucca, Daniel N.3, Slater, Annelise4, Faust, Kerry5, Mercadante, Valencia6 |
| Source: | Proceedings of the Northeast Business & Economics Association. 2020, p147-148. 2p. |
| Abstract: | The COVID-19 pandemic has certainly made its presence felt in virtually every aspect of our lives but, despite its intrusion, it hasn't diminished the opioid crisis in the U.S. - about a billion opioids have saturated the market over the last nine years (Rich, Higham and Horwitz, 2020; CDC, 2020). While media coverage about COVID is taking center stage, the required confinement is actually increasing the intensity of the opioid crisis (Silva and Kelly, 2020). The vast majority of research continues to vilify the pharmaceutical industry, deservedly so for some companies, such as Ensys, Cephalon and Purdue Pharma, maker of the drug everyone knows by name, OxyContin® (oxycodone hydrochloride). However, a longitudinal review of the FDA and its involvement with the opioid crisis had not been assessed previously. Using a proprietary, long-term database constructed by one of the authors, FDA approvals for opioid products were tracked by monitoring FDA: FDA-Approved Drugs and the bulleted segment entitled Original NDA and Original BLA Approvals by Month since August 2006 (FDA, 2006). These opioid and opioidrelated medications (e.g., buprenorphine) will be combined with evaluations of FDA's 160 pronouncements/policies about opioids over the same time period to assess the FDA's behavior when dealing with opioids. Using a normative ethics approach, evaluation of what the FDA did with regard to their approval of opioids and issuance of opioid-related policies was conducted using a causal web (Russo, 2011; Porta, 2016). Results indicated that the FDA generally acted in a manner consistent with their obligation to protect the interests of individual patients as measured by their approval of at least 60 opioids over the study period (2 new molecular entities (Category 1); 41 new dosage forms and/or new combinations (Category 3, 4, and 3 and 4); 9 new manufactures (Category 5); and 8 previously marketed before an approved NDA (Category 7). Furthermore, assessment using a utilitarian approach indicated that FDA's policies/decisions did not always yield greater public welfare or protect the rights of the most critical stakeholders, the patients. Over 40 percent (40.6%; 65 of 166) of FDA's opioid-related policies were negative or neutral instead of being assessed as positive or ensuring safe and effective treatments (FDA, 2006-present). These results suggest that FDA gives greater consideration to the opioid crisis and adopts a more careful approach to the approvals of opioids and the policies it issues about them. [ABSTRACT FROM AUTHOR] |
| Subject Terms: | *COVID-19 pandemic, *Public welfare, Opioid epidemic, Normativity (Ethics), Opioids |
| Company/Entity: | United States. Food & Drug Administration |
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| ISSN: | 1936203X |
| Database: | Business Source Complete |
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