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McKesson agrees to pay record $150 million settlement for failure to report suspicious orders of pharmaceutical drugs


This news story was published on January 17, 2017.
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WASHINGTON, DC – McKesson Corporation (McKesson), one of the nation’s largest distributors of pharmaceutical drugs, agreed to pay a record $150 million civil penalty for alleged violations of the Controlled Substances Act (CSA), the U.S. Drug Enforcement Administration (DEA) announced today.

The nationwide settlement requires McKesson to suspend sales of controlled substances from distribution centers in Colorado, Ohio, Michigan and Florida for multiple years. The staged suspensions are among the most severe sanctions ever agreed to by a DEA-registered distributor. The settlement also imposes new and enhanced compliance obligations on McKesson’s distribution system.

In 2008, McKesson agreed to a $13.25 million civil penalty and administrative agreement for similar violations. In this case, the government alleged again that McKesson failed to design and implement an effective system to detect and report “suspicious orders” for controlled substances distributed to its independent and small chain pharmacy customers– i.e. orders that are unusual in their frequency, size, or other patterns. From 2008 until 2013, McKesson supplied various U.S. pharmacies an increasing amount of oxycodone and hydrocodone pills, frequently misused products that are part of the current opioid epidemic.

The government’s investigation developed evidence that even after designing a compliance program after the 2008 settlement, McKesson did not fully implement or adhere to its own program. In Colorado, for example, McKesson processed more than 1.6 million orders for controlled substances from June 2008 through May 2013, but reported just 16 orders as suspicious, all connected to one instance related to a recently terminated customer.

“This groundbreaking resolution is tough and appropriate and underscores our commitment to hold accountable all DEA registrants, including those who distribute controlled substances,” said DEA Acting Administrator Chuck Rosenberg. “DEA is committed to fighting the opioid epidemic with all of the tools at our disposal.”

In addition to the monetary penalties and suspensions, the government and McKesson agreed to enhanced compliance terms for the next five years. Among other things, McKesson has agreed to specific, rigorous staffing and organizational improvements; periodic auditing; and stipulated financial penalties for failing to adhere to the compliance terms. Critically, the settlement will require McKesson to engage an independent monitor to assess compliance – the first independent monitor of its kind in a CSA civil penalty settlement.

This was a multi-district investigation that involved the following DEA Field Divisions from around the country.

In recent years, McKesson U.S. Pharmaceutical says it has put great effort into implementing significant enhancements to how it monitors and controls the distribution of controlled substances, referred to as the company’s Controlled Substance Monitoring Program (CSMP). McKesson’s team includes numerous individuals with significant regulatory and anti-diversion expertise who play a lead role in its due diligence efforts, utilizing advanced analytical tools to closely monitor our customers’ purchases. McKesson is proud of its CSMP and will continue its efforts to be an industry leader in the fight against prescription drug diversion.

“Pharmaceutical distributors play an important role in identifying and combating prescription drug diversion and abuse. McKesson, as one of the nation’s largest distributors, takes our role seriously. We continue to significantly enhance the procedures and safeguards across our distribution network to help curtail prescription drug diversion while ensuring patient access to needed medications,” said John H. Hammergren, chairman and chief executive officer, McKesson.

McKesson sees prescription drug diversion and abuse as an issue that needs to be addressed through a comprehensive approach that includes the patients who become addicted, doctors who write the prescriptions, the pharmacists who fill them, the distributors who fulfill and deliver pharmacies’ orders, the manufacturers who make and promote the products, and the regulators who license the above activities and determine supply.

“We are committed to tackling this multi-faceted problem in collaboration with all parties in the supply chain that share the responsibility for the distribution of opioid medications,” Hammergren concluded.

McKesson is committed to working with the DEA on an ongoing basis to identify new ways to prevent misuse of controlled substances. As part of the settlement agreement reached, McKesson and the DEA plan to meet regularly over the next five years to ensure ongoing alignment. This new level of partnership with regulators, and the enhancements McKesson has made to its CSMP, strengthens McKesson’s ability to partner with all participants in the prescription drug supply chain to help prevent diversion while ensuring services to meet patient needs.

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13 Responses to McKesson agrees to pay record $150 million settlement for failure to report suspicious orders of pharmaceutical drugs

  1. Anonymous Reply Report comment

    January 19, 2017 at 6:50 am

    Having worked in a pharmacy, I can tell you prescription drugs, ordering and receiving is a very tight ship. Especially narcotic drugs. Not only do you have paperwork you have to keep up with, there is maximums a pharmacy can order without a full blown investigation in to where they are going, and why your pharmacy has more need for them. I think pharmaceutical’s NEED tougher restrictions. There is so much fraud, theft, and abuse of drugs.

  2. John Reply Report comment

    January 18, 2017 at 7:41 pm

    maybe another reason they opened the Clear Lake Iowa location after being banned from 4 States…. gotta go somewhere else.

  3. Anonymous Reply Report comment

    January 18, 2017 at 8:59 am

    The fine is a drop in the bucket to this company. Then to top it off all the critical talking points are delivered by the company as they did no wrong. We will continue to blah blah blah and then we will also blah blah blah all the while improving our blah blah blah. Give me a break, a billion wouldn’t have been enough. Look at the financials of this company, it’s staggering. We live in a pill pushing society and their one of the biggest dealers.

  4. Anonymous Reply Report comment

    January 18, 2017 at 7:27 am

    They make billions selling drugs to illegal sources and we pay the price. Put their CEO in jail and this crap will stop.

    • Anonymous Reply Report comment

      January 18, 2017 at 7:44 am

      Please explain…… making billions by selling to illegal sources. You making this stuff up again?

      • Anonymous Reply Report comment

        January 18, 2017 at 11:14 am

        Illegal sources….. thats a serious charge. Can you back that up?

        • Anonymous Reply Report comment

          January 18, 2017 at 6:06 pm

          Are you stupid? Read the damn article and if you can’t understand what it printed get someone to explain it to you.

          • Anonymous

            January 18, 2017 at 7:01 pm

            The article says absolutely nothing about selling drugs to illegal sources. Those are your facts not what Matt has reported.

          • Anonymous

            January 19, 2017 at 7:01 am

            Larry has his panties all in a bunch again. Just ignore him

        • Anonymous Reply Report comment

          January 19, 2017 at 7:44 am

          Sorry about that. The Sneaky TROLL decided to post a personal attack and when I took it out (As I will do every time) it took out your comment too.

          • Anonymous

            January 19, 2017 at 8:17 am

            I dont want an apology from you…. I want you to stop being the troll Nazi.

          • Anonymous

            January 19, 2017 at 8:56 am

            What makes you think I give a shit about what a cowardly troll like you wants?

  5. Anonymous Reply Report comment

    January 18, 2017 at 4:34 am

    why use homemade drugs when u can get them from McKesson with no problem