Amid opioid epidemic, rules for drug companies are loosened
When it comes to combating the nation’s opioid epidemic, politicians of all stripes say they are fully committed.
President Obama wants to spend a billion dollars on new treatment programs. Hillary Clinton and Donald Trump talk about the ravages of addiction and the need for solutions. And Congress earlier this month passed a package of legislation to prevent overdoses, bolster law enforcement and improve recovery programs.
But this spring, with little attention and virtually no public opposition, lawmakers approved and the president signed a new law that makes it more difficult for government to take action against a key player in the crisis: the pharmaceutical industry.
The law allows companies accused of failing to report suspicious orders of dangerous drugs to submit a “corrective action plan” to persuade the Drug Enforcement Administration to postpone or abandon proceedings against them. The law also raises the bar for the DEA to temporarily suspend their licenses.
Supporters maintain that the law, the Ensuring Patient Access and Effective Drug Enforcement Act of 2016, keeps medication available for legitimate patients and will encourage cooperation between industry and law enforcement.
Critics say it takes pressure off companies to detect and report drugs flowing to the black market. The top DEA official for regulation of pharmaceutical firms left the agency last fall, in part, he said, because of a bitter dispute with members of Congress over his view that the bill was misguided and would worsen the epidemic.
“They are taking the word of industry rather than the government’s expert in diversion control,” said Joseph Rannazzisi, who stepped down in October after nearly a decade as DEA deputy assistant administrator.
A Los Angeles Times investigation published earlier this month revealed that drug maker Purdue Pharma, which has reaped more than $31 billion from the painkiller OxyContin, collected extensive evidence suggesting illegal trafficking of its drug and, in many cases, did not share the information with law enforcement or cut off the flow of pills.
One drug ring that Purdue monitored was operating for several years in the district of Rep. Judy Chu (D-Monterey Park). Chu co-sponsored the bill in the House. She has received more than $31,000 in contributions from the pharmaceutical industry, according to the nonpartisan Center for Responsive Politics.
A spokesman said Chu was unavailable for an interview. In a statement, she said she was “deeply concerned about the lack of reporting by Purdue,” but believed the new law “would result in the guidance needed to end the prescription drug epidemic.”
More than 194,000 people have died since 1999 from overdoses involving opioid painkillers, and abuse of the drugs has contributed to a national resurgence in addiction to heroin, another opiate.
The new law does not alter the agency’s ability to pursue criminal charges or civil penalties. But it provides a way for companies to try to avoid the DEA’s administrative penalties, which can include the loss or suspension of a federal license, known as a registration, that allows them to make, sell or dispense controlled substances.
Here’s how a single L.A. drug ring pumped more than a million Oxy pills onto the black market.
The push for a new law followed action the DEA took in 2012 against a major national wholesaler, Cardinal Health Inc., over millions of painkillers supplied to two CVS pharmacies in Sanford, Fla. Data showed enough pills flowing to the small city for every man, woman and child to have 59 doses, according to court records. One CVS pharmacist described her oxycodone customers as “shady” and told DEA agents she had to set a daily limit on opioid prescriptions to ensure there would be enough for “real pain patients,” the records stated.
The DEA accused Cardinal and CVS of failing to maintain “effective controls” against diversion as required by the federal Controlled Substances Act. Cardinal was banned from shipping prescription drugs from a Florida facility for two years and CVS paid a $22-million settlement.
In the wake of the investigation, Cardinal and CVS, along with many others in the industry, began lobbying for the new law, which changes parts of the Controlled Substances Act. It allows companies accused of violations to submit a corrective action plan that addresses the DEA allegations before the DEA decides on any enforcement action. Federal officials must consider the plan in deciding whether to move forward with enforcement action or stop or postpone it.
Under the new law, companies have little incentive to take steps to prevent abuse of their drug — unless and until the DEA accuses them of violating the law, said Carmen Catizone, executive director of the National Assn. of Boards of Pharmacy.
“Our concern at this point is we have 40 people a day dying of opioid abuse,” he said “We think the bill goes way too far.”
D. Linden Barber, a former DEA lawyer who now represents manufacturers and wholesalers, said the law still gives the DEA the option of revoking a company’s license.
“The law doesn’t require the agency to say, OK, I’m walking away. It just says, consider it,” he said.
Another part of the law imposes a higher standard for suspending licenses temporarily while awaiting court approval. Previously, the DEA could shut companies, pharmacies and doctors down if it determined there was an “imminent danger” to the public. The new law defines that danger as a “substantial likelihood of an immediate threat” of death, serious bodily harm or drug abuse.
Our concern at this point is we have 40 people a day dying of opioid abuse. We think the bill goes way too far.
Carmen Catizone, executive director of the National Assn. of Boards of Pharmacy
Former DEA official Rannazzisi said the change offered “total protection” against temporary suspension for manufacturers and wholesalers. It often takes weeks for drugs to get through the supply chain from manufacturer to distributor to pharmacy, making it difficult for the DEA to argue that a failure by those companies to report and reject suspicious orders constituted an immediate threat, he said.
Barber, the industry lawyer, said the change prevented the agency from shutting down companies for problems employees had already identified and fixed, something he said has occurred in the past.
“The fact that someone did something wrong, realized it was wrong, took action to correct it — that doesn’t give the agency the right to come in four to six months later and seek a suspension,” he said.
The bill encountered little resistance in either the House or the Senate, and at hearings on the legislation, some lawmakers criticized the DEA for being overly aggressive with drug companies. At hearings in 2014, Rep. Michael Burgess (R-Texas) accused the DEA of “bullying, aggressive and narrow-minded tactics” and Rep. Tom Marino (R-Pa.) told the head of the DEA to “seek collaboration with legitimate companies that want to do the right thing.”
“Big fines make headlines, but that is all they do: Press releases do not save lives,” Marino said.
One current DEA official who spoke on the condition of anonymity said the agency did not consider the new law necessary, but recognized it had strong political support and did not oppose it publicly.
Behind closed doors, discussions between congressional staffers and Rannazzisi about the proposed law became so heated that Marino and another sponsor of the bill sent a letter to the Justice Department asking for an investigation into what they alleged was an “attempt to intimidate the United States Congress.”
Rannazzisi said he merely was expressing his concerns about the bill’s impact.
“I said, ‘Well, there’s thousands of people dying of opioid overdoses and we’re investigating people and this bill is going to provide protection for the people we are investigating,’” he said. “I don’t know how they felt that was a threat.”
Marino, who has received $136,000 in campaign contributions from the pharmaceutical industry since 2011, declined to be interviewed. In a statement, he said the law doesn’t impede the DEA’s enforcement ability.
“Rather, it forces the DEA to focus on bad actors, collaborate for better diversion control results and allows patients — often suffering from cancer — to access medication they need without delay,” he said.
Several registrants accused of violating the Controlled Substances Act have already submitted corrective action plans, according to testimony at a June Senate hearing.
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