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Cities with high numbers of opioid overdoses are suing drug manufacturers for downplaying the serious side effects of this drug class. On this subject, the Justice Department’s Inspector General released a critical assessment at the beginning of October 2019. The lengthy document indicates the Drug Enforcement Administration (DEA) did not step in as overdoses increased and painkillers flooded the black market. The Inspector General claims their practices, many with loopholes and insufficient monitoring, are partially to blame.
As the opioid epidemic and subsequent overdoses grew sharply from 1999 through 2013, the DEA’s production quota for oxycodone also increased five times from 2002 to 2013. Even though the agency reduced the quota by roughly 25 percent in 2017, deaths related to opioids hit a record high that year and were likely influenced by lax oversight that let prescription painkillers become a hot commodity.
DEA or Drug Manufacturers?
The DEA establishes annual amounts, or quotas, for prescription painkillers produced in the United States. According to a piece in the Washington Post, the DEA claims their quotas are based on the drug company’s demands. They further allege that pulling back could have created a shortage, putting patients who require these medications in jeopardy. In response, the DEA has laid part of the blame on drug companies like Purdue Pharma for failing to adequately monitor their products.
The Inspector General further asserts that, during the early years of the crisis, the DEA took its time in responding, did not question its dated and ineffective practices and created structural gaps that allowed illegal distribution to slip through the cracks.
What Role Did the DEA Play?
Based on the DOJ’s report, the DEA’s lack of oversight emerged through several points of its operation:
- No Background Checks: Also called “pre-licensing investigations,” the DEA did not screen doctors, pharmacists, dentists and other medical professionals prescribing or dispensing prescription painkillers. Instead, the process simply required these entities to self-report, including for criminal behavior. Because the DEA did not cross-reference applications with state medical and pharmacy boards, entities could easily add inaccurate information.
- Easy Reapplication: What happened if a doctor’s or pharmacist’s license was revoked? Rather than suspending the entity, the DEA let them reapply right away – sometimes just a day after revocation. Doctors could also move to another state, set up a practice and reapply without having the revocation taken into account.
- Suspension Orders Cut: From 2013 to 2017, the agency withheld issuing immediate suspension orders, a sharp drop from 2012. While the agency picked up after 2017 and has since taken away roughly 900 licenses, it’s ultimately too little, too late.
- Non-Detected Questionable Orders: Using an older tracking system meant to identify suspicious orders from drugstores, the agency’s system rarely red-flagged unusually large or frequent orders from distributors. Based on this data, the DEA has claimed a very small percentage of its 1.8 million registered entities are truly involved in any illegal activity.
- Inconsistent Reporting: While some drug companies reported on a monthly basis, others only did so every quarter. For this reason, the DEA would take roughly a year to identify and investigate questionable orders. At the same time, the DEA discontinued its medical examiners database in 2007 and four years later, the Department of Health and Human Services halted its network meant to detect early-stage drug abuse. These moves reduced the amount of information recorded and used to identify illegal distribution through medical practitioners.
- Paper Prescriptions: The DEA continued to let doctors and pharmacies use paper prescriptions; electronic opioid prescriptions would have made the abuse more evident. Because smaller, independent pharmacies did not have the advanced software, the DEA let it slide.
According to the Centers for Disease Control and Prevention, opioids are responsible for 300,000 deaths over the past 20 years. While states, cities and individuals are starting to hold companies like Purdue and Johnson & Johnson accountable, the DEA likely had an opportunity to curtail illegal activity early on but turned a blind eye.
Were you or a loved one a victim of the opioid crisis? Whether a doctor failed to review all side effects or a drug manufacturer didn’t cover all risks, these larger entities must be held accountable for years of deceptive practices.