DEA Database Shows Generic Drug Manufacturers Contributed Most to the Opioid Epidemic

Opioid Epidemic Justice: New Information, New Culprits – Generic Drug Manufacturers

Prescription opioids have contributed greatly to the overdoses which have killed over 400,000 Americans since 1999. In recent years, powerful corporations and executives in the pharmaceutical industry have been facing trial and paying settlements for deceptively marketing opioid-based painkillers and bribing doctors to prescribe them. Johnson and Johnson, Purdue Pharmaceuticals, and other major players in Big Pharma have attracted the most attention from prosecutors and the media. However, new information has revealed that lesser-known, generic drug manufacturers actually manufactured most of the addictive pills which caused the ongoing epidemic of opioid addiction.

What Is the Difference Between Generic and Brand-name Opioids?

In most ways, generic drugs are identical to brand-name medications. They share the same effects, risks, and recommended doses, and they’re both subject to FDA approval. Therefore, any generic drug should be as safe as its brand-name counterpart. Generic opioids and brand-name opioids are equally potent and addictive. The difference between generic and brand-name opioids is that generic opioids cost less to manufacture. Consequently, they cost less for patients to buy.

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In general, drug companies cannot start to manufacture generic medications until the patent for the original brand-name product expires. In 2004, the production and sale of generic opioid medications skyrocketed when federal courts rescinded the patent which Purdue Pharmaceuticals held on OxyContin. The opioid ingredient in OxyContin in oxycodone. This occurred only several years after OxyContin had entered the market, so there was not much time for researchers to study the addictive power of oxycodone and other opioids.

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How Generic Drug Manufacturers Fueled the Opioid Epidemic

The U.S. Drug Enforcement Agency (DEA) tracked the production, distribution, and sale of every opioid pill in the United States from 2006 to 2012. Last month, the DEA published its database with this information in response to requests from The Washington Post and the Charleston Gazette-Mail, a West Virginia newspaper. The database is called the Automation of Reports and Consolidated Orders System, or ARCOS. According to ARCOS, from 2006 to 2012, 76 billion opioid pills were produced and sold to patients in America. In 2006, there were 8.4 billion opioid pills in distribution. That number rose to 12.6 billion pills by 2012.

The vast majority of these pills originated from three generic opioid manufacturers:

  • SpecGx, a subsidiary of the Ireland-based pharmaceutical company Mallinckrodt
  • Par Pharmaceutical, a subsidiary of Endo Pharmaceuticals, which is also headquartered in Ireland
  • Actavis, a subsidiary of the Israeli company Teva Pharmaceuticals

ARCOS shows that SpecGx manufactured about 38% of the 76 billion opioid pills and that Actavis manufactured about 35%. Many of these pills went to distributors who then sent them to pharmacies and pain clinics in areas of the country which already had high rates of addiction and overdoses. The ARCOS database alerted DEA officials as early as 2011 that these three companies were supplying most of the country’s opioids.

I was shocked. I couldn’t believe it. Mallinckrodt was the biggest, and then there was Actavis. Everyone had been talking about Purdue, but they weren’t even close.

In response, the DEA asked the companies to voluntarily reduce their opioid production. Recently-publicized internal documents from SpecGX, Par, and Actavis show that they did not comply with these requests. Additionally, all three of the manufacturers failed to implement an effective system for monitoring their opioid sales for suspicious orders.

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These three companies actually controlled 88% of the American opioid market, while Purdue Pharmaceuticals only controlled about 3%. However, since they weren’t well-known, they avoided DEA scrutiny for many years. During the ARCOS time period, all three companies earned tremendous profits. For example, Par Pharmaceutical reported over $1 billion in revenue in 2012, and the company was worth $8 billion when Endo acquired it in 2015. Actavis experienced even more growth by selling billions of generic hydrocodone pills. Teva Pharmaceuticals acquired Actavis in 2016 for a price tag of $40 billion.

Nevertheless, now that the world knows the truth about the role these companies played in fueling the opioid crisis, it is likely they will all have to pay steep settlements and defend themselves in court.

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