Drug manufacturers and distributors have been taking quite a bit of heat lately and the forecast doesn’t look to be cooling down anytime soon. The opioid addiction crisis continues to break records and is causing a public cry for answers. So far, four states have filed or plan to file lawsuits against some of the biggest names in the industry, like Teva, Endo, Johnson & Johnson, and Purdue Pharma. The Attorney Generals of Missouri, Arizona, Ohio, and Mississippi claim that prescription opioid manufacturers engaged in fraudulent marketing tactics and intentionally understated the risks of opioid painkillers in the name of profit, which they claim played a significant role in the opioid addiction crisis.
Now, a top-ranking senator is expanding efforts to investigate drug companies to determine their exact role in the epidemic and if there was criminal intent. What’s even more disturbing, is this probe expansion is aimed specifically to investigate the influx of prescription opioids on the black market. The probe questions whether some companies illegally distribute medication to unlicensed companies or individuals. It also aims to unmask the enablers of illegal pharmacies known as “pill mills.”
What Is The Opioid Addiction Crisis Probe?
Sen. Claire McCaskill (D-Mo) of the Senate Homeland Security and Governmental Affairs Committee initially launched the probe in March to investigate marketing tactics of several major pharmaceutical companies and the role that played in the opioid addiction crisis, similar to the lawsuits of the four states mentioned above. Now, just several days ago, the senator announced she had sent letters to drugmakers Mallinckrodt PLC, Endo International PLC, Teva Pharmaceutical Industries, and Allergan PLC, as well as to distributors McKesson Corp., AmerisourceBergen Corp. and Cardinal Health Inc. demanding more evidence and also signaling a probe expansion. The letters request documents and information about the steps these companies have made to prevent drugs from diverting to the black market.
Because these companies manufacture highly controlled substances, they are required to make an extensive effort to prevent drug diversion and are ultimately responsible for where the drugs end up. Pharmaceutical companies must document all transactions and customers, as well as take action to ensure their clients are properly licensed and following proper protocol. This probe suggests these companies are failing at enforcing their procedures and protocol required by law, which likely played a massive role in the growing opioid addiction crisis.
In a public statement, Sen. McCaskill said, “We’ve seen numerous reports that potentially hundreds of millions of opioid pills wound up on the black market, fueling a nationwide epidemic,” and went on to say, “We need a better understanding of how committed these companies are to preventing this type of drug diversion or whether they are turning a blind eye.”
So far, 4 companies have replied to requests for public comment regarding the enhanced probe into the opioid addiction crisis. AmerisourceBergen said it would respond to the letter and continue “to do our part in combating prescription drug abuse.” Endo stated that it, “continues to fully support all efforts to reduce opioid diversion, abuse, and misuse.” Mallinckrodt said that they, “will continue working with her [Sen. McCaskill] office on the important issue of prescription drug abuse and misuse.” McKesson stated, “We do not prescribe medicine; rather, we fill orders placed by DEA-licensed pharmacies as prescribed by DEA-licensed physicians,” but they also agreed that “too many opioids are prescribed and misused.”
What Are “Pill Mills” And Do Manufacturers Combat Them?
A “pill mill” is an illegal pharmacy that sells and distributes medication without proper prescriptions. These pharmacies played a major role in the opioid crisis, diverting hundreds of millions of pills into the black market. Florida was hit hardest with these fraudulent pharmacies due to a lack of regulations and prescription databases, which was a major factor in the opioid addiction crisis.
Many states have a database system that is updated in real-time when a doctor writes a prescription. This allows pharmacies and doctors to see exactly who has been prescribed what, which prevents patients from seeing multiple doctors and receiving multiple identical prescriptions. Since Florida lacked this system, people from all over the country and even Canada would make the trip to fill as many prescriptions as possible and smuggle them nationwide. Additionally, a lack of regulation even allowed pharmacies to simply sell the pills without a prescription at all.
Several years ago, Florida finally adopted this system but, unfortunately, the damage had already been done. Many people switched to heroin as a result of the sudden decrease of opioids on the black market.
This probe will examine the steps drugmakers made to monitor suspicious orders (in Florida, some orders asked for tens of thousands of more pills than the rest of the country’s average order size), notifications the companies sent to the DEA regarding suspicious clients, a list of each distributor’s facilities that have been penalized by the DEA, and information describing how opioid revenue and adherence to corporate compliance issues affects executive compensation. This information will be extremely pertinent to the opioid addiction crisis and whether drugmakers may have triggered the epidemic.
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