AmerisourceBergen Response to the Department of Justice Complaint – An Inevitable Outcome of Regulatory and Enforcement Outsourcing

The complaint filed by the Department of Justice attempts to shift the onus of interpreting and enforcing the law from the Department of Justice and Drug Enforcement Administration (DEA) to an industry they are tasked with regulating and policing. The simple fact is DEA controlled and operated systems like the ability to limit the amount of opioid medication available through manufacturing quotas; and maintenance of registration for pharmacies that dispense controlled substances like opioid medications were not used to stem the crisis of opioid misuse and abuse. Instead former bureaucrats at the DEA simply tried to make private companies take on their responsibility of determining what pharmacies should be able to dispense opioid medication.

 

Detailed context surrounding the five pharmacies cited in the DOJ’s complaint reinforce these facts:

Pharmacy 1 

  • Pharmacy 1 was a closed-door specialty pharmacy focusing on oncology and oncology pain management and was accredited by a number of reputable third-party health care accreditation organizations.
  • The DEA maintained Pharmacy 1’s controlled substance registration even though it received multiple suspicious order reports
  • AmerisourceBergen and another distributor (H.D. Smith, which was later acquired by AmerisourceBergen) both terminated Pharmacy 1’s account and notified the DEA of those terminations 

 

Pharmacy 2

  • AmerisourceBergen reported over 50 suspicious orders on Pharmacy 2 to the DEA 
  • AmerisourceBergen restricted sales of controlled substances to Pharmacy 2 and then ultimately terminated the pharmacy’s account in 2016.
  • The DEA finally suspended Pharmacy 2’s controlled substance registration in 2017 

 

Pharmacy 3

  • AmerisourceBergen reported over 200 orders deemed to be suspicious to the DEA on Pharmacy 3 
  • DEA never followed up with AmerisourceBergen on these reports
  • AmerisourceBergen investigated further through a consulting firm the company hired comprised of former DEA diversion investigators and ultimately terminated Pharmacy 3’s account
  • The DEA maintained Pharmacy 3’s controlled substance registration after AB terminated the account.

 

Pharmacy 4

  • AmerisourceBergen reported nearly 100 orders from Pharmacy 4 to the DEA as suspicious.
  • AmerisourceBergen monitored Pharmacy 4, funded audits from consultants made up of former DEA investigators and obtained letters of support from physicians who referred patients to Pharmacy 4
  • AmerisourceBergen’s consultant report showed that DEA investigators had visited Pharmacy 4 and had never followed up either directly with the pharmacy or AmerisourceBergen 
  • The DEA maintained the registration of Pharmacy 4 and AmerisourceBergen continued to deliver medications to the pharmacy 

 

Pharmacy 5

  • AmerisourceBergen reported nearly 20 orders deemed to be suspicious from Pharmacy 5 to the DEA
  • DEA never followed up with AmerisourceBergen on these reports
  • AmerisourceBergen investigated further through a consulting firm they hired comprised of former DEA diversion investigators
  • AmerisourceBergen ultimately terminated Pharmacy 5’s account and the DEA maintains their controlled substance registration to this day

 

 

In each of these examples – which were cherry picked by DOJ from the thousands of pharmacies AmerisourceBergen delivers medicines to be the most incriminating to the company – the DEA received information directly from AmerisourceBergen on the pharmacy and its ordering of controlled substances like opioids. And in each case AmerisourceBergen invested time and money to take action before the DEA did. Perhaps the most fundamental demonstration of this fact is that the Department of Justice complaint never accuses AmerisourceBergen of delivering opioid based medicines to a pharmacy that the Department of Justice’s own agency – the DEA – had not registered themselves. 

 

An objective review of the facts shows that the DOJ’s complaint about AmerisourceBergen is simply an attempt to shift blame from past administrations at the Department of Justice and specifically their agency, the DEA, to industries they were tasked with regulating. Congress investigated the DEA’s conduct and found that they did not use tools like registration and manufacturing quotas to address opioid abuse and misuse. And recently a Federal Judge in West Virginia noted in a decision for AmerisourceBergen and two of its competitors, that the companies had maintained diversion control systems in accordance with the law. This sweeping decision addressed many of the same accusations that are made in this DOJ complaint and concluded that AmerisourceBergen had complied with the law.