According to new data, the biggest three generic drug manufacturers controlled 88% of the US market for opioids.
Who is to blame for the opioid epidemic?
In recent years, as outcry over the epidemic has grown, more attention has been focused on Purdue Pharma, Johnson and Johnson and other well-known companies that manufactured opioids. However, recently-released data shows that generic drug manufacturers played a massive role in the supplying opioids.
The biggest three generic drug manufacturers —Mallinckrodt Pharmaceutical’s SpecGx, Actavis Pharma and Par Pharmaceutical — controlled 88% of the U.S. market for opioids. Purdue Pharma, for comparison, controlled 3.3% of the market, according to data from the DEA.
Barbara J. Boockholdt was the chief of the regulatory section at DEA’s Office of Diversion Control when she checked a DEA database in 2011 and was stunned with what she learned about which companies were producing and distributing the most opioids.
“I was shocked; I couldn’t believe it, Mallinckrodt was the biggest, and then there was Actavis,” she told The Washington Post. “Everyone had been talking about Purdue, but they weren’t even close.”
Nancy Baran, former head of customer service at Actavis, said that the company knew they were flying under the radar.
“We weren’t really a household name — none of us,” she said. “Generics are not advertised on TV. No one ever hears your name. I worked at the company for 10 years, and my friends would still ask, ‘Where?’”
“We Are Not Responsible”
Generic drug manufacturers were capitalizing on the profit to be made from opioid pills and patches, but at the same time they were ignoring information from regulatory agencies that they were not following the law when it came to monitoring suspicious orders. In fact, Par Pharmaceutical didn’t even have a system for tracking suspicious orders.
Douglas S. Boothe, chief executive at Actavis during the height of its manufacturing, said in a recently unsealed deposition from November that his company was merely responsible for filling orders, not for concerning itself with what people did with its products.
“Once it goes outside of our chain of custody, we have no capability or responsibility or accountability,” he said. “Once we ship a valid order to a wholesaler or ship a valid order to a distributor . . . our chain of custody is finished at that point.”
When federal authorities finally approached Actavis about its role in the epidemic, the company’s vice president for ethics and compliance, Michael R. Clarke, felt the company was being treated like “street dealers.”
He said in a recently unsealed testimony that he thought authorities would take a more laid back approach, saying something like, ‘You know, that’s great, that’s fine, maybe you can do this better.’
“We were looking for that sort of interchange, and it wasn’t that,” Clarke said. “It was pretty clear that they believed that we were one of the manufacturers that led to whatever problem they identified related to diversion of opioids.”