Douglas Boothe was the leader of a little-known generic-drug maker seven years ago when federal agents approached his company with an urgent plea: Slash production of an addictive pain medication that was fueling a national crisis.
Boothe "wasn't interested" and rejected the Drug Enforcement Administration's request that Actavis voluntarily cut its supply of oxycodone to U.S. pharmacies, according to exhibits unsealed recently in a landmark lawsuit that accuses drug companies of recklessly distributing billions of addictive pain pills despite signs of abuse.
Now, Boothe is among the figures from the generic-drug industry whose decisions during the height of the country's opioid epidemic have been thrust into the national spotlight after the release of the documents.
Drugmaker Purdue Pharma and its owners, the Sackler family, have for years borne the brunt of public criticism for inventing and deceptively marketing one of the most well-known opioid painkillers, OxyContin, in the 1990s. But the records show that by 2006, as the death rate accelerated, a handful of obscure generic-drug manufacturers were selling the bulk of opioid pills flooding the country.
The documents and a DEA database that tracks every opioid pill sold in the United States from 2006 through 2012 are being made public a year after The Washington Post and the owner of the Charleston Gazette-Mail in West Virginia began pushing for their release.
The database attributes the vast majority of the 76 billion opioid pills produced and shipped from 2006 through 2012 to three companies that are now controlled by large multinational drugmakers: SpecGx, a subsidiary of Mallinckrodt in Ireland; Par Pharmaceutical, owned by Endo Pharmaceuticals, also in Ireland; and Actavis, part of Teva Pharmaceutical Industries in Israel.
The records show how these and other generic-pain-pill makers rushed to gain market share as the nation's deadliest drug epidemic spun out of control. The records also reveal that some of the manufacturers were warned by auditors or regulators that they were not meeting federal requirements for detecting suspicious orders.
Boothe, Actavis' chief executive in those years, denied culpability in a deposition unsealed Tuesday. Although federal law compels companies to monitor the pattern, frequency and amounts of drug orders, Boothe emphasized that Actavis could not control how its drugs were ultimately used.
"Once it goes outside of our chain of custody, we have no capability or responsibility or accountability," Boothe said in the November deposition. "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."
Boothe had not responded to voice mails, text messages or calls in recent days, or to messages left with his assistant at an Illinois drug company, Akorn, where he is now chief executive. Teva, Mallinckrodt and Endo declined to comment for this article.
In statements to the Post for its articles about the newly unsealed documents, the drug companies have issued numerous defenses of their actions during the crisis. They contend they were trying to sell legal painkillers to legitimate patients who had prescriptions.
They also blamed the crisis on overprescribing by physicians and on corrupt doctors and pharmacists who worked in "pill mills" that handed out drugs with few questions asked.
The companies further asserted that they should not be held responsible for the actions of those who abused the drugs and that the DEA had all the information it needed to block pills from reaching the black market.
OXYCONTIN BILLIONS
By 2004, eight years after it had been introduced, OxyContin had mushroomed into the most frequently prescribed narcotic for moderate to severe pain in the United States. For Purdue, it had been an era of enormous profitability as the exclusive producer of the drug, which earned the company more than $1 billion a year.
Typically, generic-drug companies are able to produce less-expensive versions of a patented drug only long after its introduction, by which time its risks and benefits are well known. In the case of OxyContin, however, those risks were very much in dispute. In 2007, Purdue and several current and former executives pleaded guilty in federal court and agreed to pay a total of $635 million to settle claims that they had fraudulently marketed OxyContin as a drug that was less addictive than other narcotics and that had few side effects.
Since the landmark fine for deceptive marketing, opioid manufacturers have faced few penalties. Mallinckrodt became the first in 2017, paying $35 million to settle DEA complaints it did not adequately work to detect suspicious opioid orders.
Actavis' sales of the generic version of OxyContin and other drugs containing oxycodone grew from 559 million in 2006 to more than 1.1 billion in 2012, according to the DEA database.
Even as their sales of opioids surged, the generic-drug makers maintained a low profile.
"We weren't really a household name -- none of us," Nancy Baran, Actavis' head of customer service in those years, said in a recent interview. "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?'"
Inside the DEA's headquarters near the Pentagon in northern Virginia, however, Actavis and Mallinckrodt would eventually bubble up on the radar of agents frustrated with their inability to curb the steep increase in prescribed opioids.
The DEA had tried going after unscrupulous doctors, but each case took months to stop a single bad actor. Agents had met with distributors, pressing them to cut off suspicious pharmacies, but the flow of drugs kept increasing.
In 2011, Barbara Boockholdt, then the chief of the regulatory section for DEA's Office of Diversion Control, walked across the hallway at DEA headquarters to an office that handles the agency's drug-ordering database -- known as the Automation of Reports and Consolidated Orders System -- and asked for reports on the nation's largest opioid manufacturers.
"I was shocked; I couldn't believe it, Mallinckrodt was the biggest, and then there was Actavis," Boockholdt said. "Everyone had been talking about Purdue, but they weren't even close."
Agents in Boockholdt's office analyzed the supply chains, tracing oxycodone from Actavis' plants in New Jersey to Walgreens and other pharmacies in Florida, some selling 1 million doses a year. They put together a presentation that ran more than 100 pages, a document that was made public on Tuesday, and called in Actavis for a September 2012 meeting.
In October, the DEA went knocking at the company's headquarters in Morristown, N.J., seeking a 30% to 40% voluntary reduction in the company's production of oxycodone, Michael Clarke, the company's vice president for ethics and compliance, testified in December, according to the newly unsealed documents.
He and another executive took the request to Boothe, who held firm, Clarke testified.
"You know, he wasn't interested in voluntarily reducing our quota, particularly by 30 or 40%, without understanding that there was something else to be had," Clarke said.
Clarke declined to comment for this article.
TRACKING FAILURES
Boockholdt and the DEA had already summoned executives of the largest oxycodone manufacturer -- Mallinckrodt -- to the agency's headquarters for a similar warning a year earlier.
In August 2011, DEA officials showed the company the hundreds of millions of doses of oxycodone Mallinckrodt was shipping to distributors and the number of arrests being made for oxycodone possession and sale in those areas, Boockholdt said.
The database lists Mallinckrodt subsidiary SpecGx as the maker of just over 2 billion pills that were shipped to Florida. Nationwide, the company would produce 28.9 billion pills during the years covered by the database -- more than 80 for each person in the country.
After the meeting with DEA officials, Mallinckrodt briefly reduced shipments, Boockholdt told the Post. The company also notified more than 40 of its distributors that they would no longer receive rebates if they continued to supply specific pharmacies whose orders were deemed suspicious.
But Mallinckrodt's output of opioid pills soon ramped back up, Boockholdt said.
At the time, Mallinckrodt also was failing to shore up its own system for tracking suspicious orders, according to recently released documents, which the company had fought to keep sealed.
Karen Harper, a senior manager for controlled-substance compliance, testified in a deposition that she told her superiors in 2008 that Mallinckrodt was not capable of detecting suspicious orders and that its systems needed to be upgraded. But company executives decided against hiring an outside vendor to help detect such orders, she said.
The company's outside spokesman, Daniel Yunger, said Mallinckrodt declined to comment for this article.
The other large manufacturer of generic opioids listed in the database, Par Pharmaceutical, did not even have a system to detect sales orders that had the hallmarks the government associated with drug diversion, according to an outside auditing firm whose reports were made public last week.
"There is no Suspicious Ordering Monitoring System in place," the auditors wrote in May 2010, referring to a reporting mechanism required by the DEA.
"A program must be instituted based on customers' sales volumes, seasonal fluctuations, etc., with a firm statistical analysis as the basis for such a program," wrote the auditors from the firm BuzzeoPDMA.
Par did not act on that advice for years, records show. Instead, employees inside Par's sales department were responsible for monitoring orders, according to company documents and an executive at Par's current parent company, Endo Pharmaceuticals.
As late as 2015, though, the outside auditors still had concerns about Par's oversight of opioid sales. The auditor noted that federal regulators might take issue with the company's method for vetting orders.
Information for this article was contributed by Steven Rich, Alice Crites and Julie Tate of The Washington Post.
A Section on 07/28/2019