Distributors Accused of 'Pill Dumping' in West Virginia, Questioned About Data and Compliance Practices
Leaders of the House Energy and Commerce Committee are expanding their investigation into alleged “pill dumping” of opioid painkillers into West Virginia by regional distributors.
Committee leaders sent letters dated Jan. 26 to two regional drug distributors, Miami-Luken and H.D. Smith, demanding answers to questions such as whether the companies used “any analytic tools” to assess whether the large amount of pills they distributed to pharmacies in certain towns was in proportion to the towns’ relatively small populations.
The Controlled Substances Act requires registrants to monitor orders and inventory for signs of diversion, to take steps to prevent such diversion, and to report incidents of suspicious activity to the Drug Enforcement Administration.
The letters detail evidence of diversion on an epic scale. The letter to Miami-Luken, for example, notes that over a 10-year period ending in 2016, distributors shipped more than 20 million hydrocodone and oxycodone pills to Williamson, West Virginia, where only two pharmacies served a population of fewer than 3,200 in 2010.
Reporting Suspicious Activity
In another example, the letter asks Miami-Luken why it continued to sell opioids to a pharmacy in Beckley, West Virginia, even after its consultant suggested in site visit reports, dated through November 2013, that there may have been suspicious activity at pain clinics whose prescriptions were filled at the pharmacy. "How did Miami-Luken's compliance department use site visit reports?" the letter asks. "Did these reports, for example, play any role in Miami-Luken's decision to continue distributing pills to this pharmacy until 2015?"
The letters to Miami-Luken and H.D. Smith were sent by a bipartisan group, including committee Chairman Greg Walden, R-Ore.; ranking member Rep. Frank Pallone Jr., D-N.J.; Oversight and Investigations Subcommittee Chairman Gregg Harper, R-Miss.; Oversight and Investigations Subcommittee ranking member Diana DeGette, D-Colo.; and Rep. David McKinley, R-W. Va.
During the Obama administration, federal officials repeatedly called on pharmaceutical and health care providers to be "good corporate citizens" by using their sales data analytics to help enforcement agencies detect Medicare and Medicaid fraud. The Justice Department in 2017 announced that a drug manufacturer had agreed to monitor downstream sales of opioids from distributors to independent pharmacies and pain clinics, and to report suspicious activity to DEA. Also in 2017, DOJ announced that McKesson Corporation, which is one of the largest pharmaceutical distributors, would pay $150 million in part to settle allegations that it failed to report suspicious orders.
According to its latest annual regulatory agenda, the Drug Enforcement Administration plans to begin a rulemaking soon (RIN: 1117-AB47) to define the term "suspicious order" and to clarify the steps distributors and other registrants must take in reporting suspicious orders.
For More Information
For more on the committee's investigation, see https://energycommerce.house.gov/news/in-the-news/ec-continues-expand-bipartisan-investigation-alleged-pill-dumping-west-Virginia/.
For more on reporting suspicious orders, see Tab 1301 in the Handbook.