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The drug industry’s triumph over the DEA
Amid a targeted lobbying effort, Congress weakened the DEA’s ability to go after drug distributors, even as opioid-related deaths continue to rise, a Washington Post and ‘60 Minutes’ investigation finds.
By Scott Higham and Lenny Bernstein
Oct. 15, 2017
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In April 2016, at the height of the deadliest drug epidemic in U.S. history, Congress effectively stripped the Drug Enforcement Administration of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets.
By then, the opioid war had claimed 200,000 lives, more than three times the number of U.S. military deaths in the Vietnam War. Overdose deaths continue to rise. There is no end in sight.
A handful of members of Congress, allied with the nation’s major drug distributors, prevailed upon the DEA and the Justice Department to agree to a more industry-friendly law, undermining efforts to stanch the flow of pain pills, according to an investigation by The Washington Post and “60 Minutes.” The DEA had opposed the effort for years.
The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.
The chief advocate of the law that hobbled the DEA was Rep. Tom Marino,
a Pennsylvania Republican who is now President Trump’s nominee to become the nation’s next drug czar. Marino spent years trying to move the law through Congress. It passed after Sen. Orrin G. Hatch
(R-Utah) negotiated a final version with the DEA.
8:45
This Pennsylvania district was devastated by opioids. Their Congressman became an ally of the drug industry. (Video: Alice Li/Photo: Michael S. Williamson/The Washington Post)
For years, some drug distributors were fined for repeatedly ignoring warnings from the DEA to shut down suspicious sales of hundreds of millions of pills, while they racked up billions of dollars in sales.
The new law makes it virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies, according to internal agency and Justice Department documents and an independent assessment by the DEA’s chief administrative law judge in a soon-to-be-published law review article. That powerful tool had allowed the agency to immediately prevent drugs from reaching the street.
Political action committees representing the industry contributed at least $1.5 million to the 23 lawmakers who sponsored or co-sponsored four versions of the bill, including nearly $100,000 to Marino and $177,000 to Hatch. Overall, the drug industry spent $102 million lobbying Congress on the bill and other legislation between 2014 and 2016, according to lobbying reports.
[TUESDAY UPDATE: Trump announces drug czar Marino will withdraw]
“The drug industry, the manufacturers, wholesalers, distributors and chain drugstores, have an influence over Congress that has never been seen before,” said Joseph T. Rannazzisi,
who ran the DEA’s division responsible for regulating the drug industry and led a decade-long campaign of aggressive enforcement until he was forced out of the agency in 2015. “I mean, to get Congress to pass a bill to protect their interests in the height of an opioid epidemic just shows me how much influence they have.”
Besides the sponsors and co-sponsors of the bill, few lawmakers knew the true impact the law would have. It sailed through Congress and was passed by unanimous consent, a parliamentary procedure reserved for bills considered to be noncontroversial. The White House was equally unaware of the bill’s import when President Barack Obama signed it into law, according to interviews with former senior administration officials.
Top officials at the White House and the Justice Department have declined to discuss how the bill came to pass.
Lobbying expenses, 2014-2016
Groups reported lobbying expenditures of more than $102 million related to the Ensuring Patient Access and Effective Drug Enforcement Act and other bills.
Pharmaceutical Research and Manufacturers of America
$40.8M
CVS Health
$32.5M
National Association of Chain Drug Stores
$8M
National Community Pharmacists Association
$5.4M
AmerisourceBergen
$3.8M
Healthcare Distribution Alliance
$3.5M
McKesson
$2.9M
Rite Aid
$2.8M
Walgreens
$1.4M
Cardinal Health
$1M
Includes lobbying efforts of more than $5,000.
Source: U.S. Senate Lobbying Disclosure
Electronic Filing System
Michael Botticelli, who led the White House Office of National Drug Control Policy at the time, said neither Justice nor the DEA objected to the bill, removing a major obstacle to the president’s approval.
“We deferred to DEA, as is common practice,” he said.
The bill also was reviewed by the White House Office of Management and Budget.
“Neither the DEA nor the Justice Department informed OMB about the policy change in the bill,” a former senior OMB official with knowledge of the issue said recently. The official spoke on the condition of anonymity because of the sensitivity of internal White House deliberations.
The DEA’s top official at the time, acting administrator Chuck Rosenberg,
declined repeated requests for interviews. A senior DEA official said the agency fought the bill for years in the face of growing pressure from key members of Congress and industry lobbyists. But the DEA lost the battle and eventually was forced to accept a deal it did not want.
“They would have passed this with us or without us,” said the official, who spoke on the condition of anonymity. “Our point was that this law was completely unnecessary.”
Loretta E. Lynch, who was attorney general at the time, declined a recent interview request.
Obama also declined to discuss the law. His spokeswoman, Katie Hill, referred reporters to Botticelli’s statement.
The DEA and Justice Department have denied or delayed more than a dozen requests filed by The Post and “60 Minutes” under the Freedom of Information Act for public records that might shed additional light on the matter. Some of those requests have been pending for nearly 18 months. The Post is now suing the Justice Department in federal court for some of those records.
Hatch’s spokesman, Matt Whitlock, said the DEA, which had undergone a leadership change, did not oppose the bill in the end.
“We worked collaboratively with DEA and DOJ .?.?. and they contributed significantly to the language of the bill,” Whitlock wrote in an email. “DEA had plenty of opportunities to stop the bill and they did not do so.”
Marino declined repeated requests for comment. Marino’s staff called the U.S. Capitol Police when The Post and “60 Minutes” tried to interview the congressman at his office on Sept. 12. In the past, the congressman has said the DEA was too aggressive and needed to work more collaboratively with drug companies.
DEA officials redacted the information contained in the document above, which was obtained by The Washington Post under the Freedom of Information Act, citing an exemption from the law that protects internal agency discussions. Read the bill and other documents involved in reporting this story.
Drug industry officials and experts blame the origins of the opioid crisis on the overprescribing of pain pills by doctors. The industry notes that the DEA approves the total amount of opioids produced each year.
Industry officials defended the new law as an effort to ensure that legitimate pain patients receive their medication without disruption. The industry had long complained that federal prescription drug laws were too vague about the responsibility of companies to report suspicious orders of narcotics. The industry also complained that the DEA communicated poorly with companies — citing a 2015 report by the Government Accountability Office — and was too punitive when narcotics were diverted out of the legal drug distribution chain.
“To be clear — this law does not ‘decrease’ DEA’s enforcement against distributors,” said John Parker, a spokesman for the Healthcare Distribution Alliance, which represents drug distributors. “It supports real-time communication between all parties in order to counter the constantly evolving methods of drug diversion.”
But DEA Chief Administrative Law Judge John J. Mulrooney II
has reached the opposite conclusion.
“At a time when, by all accounts, opioid abuse, addiction and deaths were increasing markedly” the new law “imposed a dramatic diminution of the agency’s authority,” Mulrooney wrote in a draft 115-page article provided by the Marquette Law Review editorial board. He wrote that it is now “all but logically impossible” for the DEA to suspend a drug company’s operations for failing to comply with federal law. The agency declined to make Mulrooney available for an interview.
Linden Barber: a critical connection
Barber provided a critical connection between DEA leadership, Congress, and the pharmaceutical industry.
Congress
DEA/DOJ
Lobby
Industry
April 2006
Barber named top lawyer for the DEA’s Office of Diversion Control.
2006-2007
Rannazzisi and Barber launch a crackdown on drug distributors.
September 2011
After Marino introduces a third version of his bill, Congress holds a hearing. Barber testifies in favor of the legislation.
February 18, 2014
Rep. Tom Marino introduces the first version of the Ensuring Patient Access and Effective Drug Enforcement Act.
June 4, 2014
An email from a Justice legislative affairs officer says that the Marino bill was written by Barber.
January 27, 2015
After Marino introduces a third version his bill, Congress holds a hearing. Barber is the featured witness testifying in favor of the legislation.
April 19, 2016
President Obama signs the bill into law.
July 2017
Barber joins Cardinal Health as a senior vice president in charge of regulatory affairs.
Open full timeline
Deeply involved in the effort to help the industry was the DEA’s former associate chief counsel, D. Linden Barber.
While at the DEA, he helped design and carry out the early stages of the agency’s tough enforcement campaign, which targeted drug companies that were failing to report suspicious orders of narcotics.
When Barber went to work for the drug industry in 2011, he brought an intimate knowledge of the DEA’s strategy and how it could be attacked to protect the companies. He was one of dozens of DEA officials recruited by the drug industry during the past decade.
Barber played a key role in crafting an early version of the legislation that would eventually curtail the DEA’s power, according to an internal email written by a Justice Department official to a colleague. “He wrote the Marino bill,” the official wrote in 2014.
Barber declined repeated requests for an interview.
With a few words, the new law changed four decades of DEA practice. Previously, the DEA could freeze drug shipments that posed an “imminent danger” to the community, giving the agency broad authority. Now, the DEA must demonstrate that a company’s actions represent “a substantial likelihood of an immediate threat,” a much higher bar.
“There’s no way that we could meet that burden, the determination that those drugs are going to be an immediate threat, because immediate, by definition, means right now,” Rannazzisi said.
Today, Rannazzisi is a consultant for a team of lawyers suing the opioid industry. Separately, 41 state attorneys general have banded together to investigate the industry. Hundreds of counties, cities and towns also are suing.
“This is an industry that’s out of control. If they don’t follow the law in drug supply, and diversion occurs, people die. That’s just it, people die,” he said. “And what they’re saying is, ‘The heck with your compliance. We’ll just get the law changed.’ ”
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