[Congressional Record Volume 164, Number 46 (Thursday, March 15, 2018)]
[Senate]
[Pages S1766-S1767]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself and Mrs. Capito):
  S. 2561. A bill to authorize the Attorney General to suspend a 
controlled substances registration if there is a likelihood of a threat 
of diversion of a controlled substance, and for other purposes; to the 
Committee on the Judiciary.
  Ms. FEINSTEIN. Mr. President, I rise today with my colleague, Senator 
Capito, to introduce the Stopping Suspicious Orders of Opioids Act.
  In 2016, the opioid epidemic caused more than 42,000 deaths in the 
United States.
  In 2017, this epidemic was declared a public health emergency.
  Now, more than 400 State, local, and Tribal governments have filed 
suits (some consolidated, some individual) against opioid manufacturers 
and distributors for their alleged roles in fueling and perpetuating 
this devastating crisis. The U.S. Justice Department, or DOJ, has filed 
a statement of interest in these lawsuits, which are currently pending.
  As our Nation struggles to effectively address the opioid epidemic, 
one thing is clear: there is no silver bullet.
  Yet, it is also clear that law enforcement can play a critical role 
in preventing and reducing overdose deaths.
  That is why we must ensure that law enforcement has and uses the 
necessary tools to hold opioid manufacturers, distributors and others 
accountable when they fail to properly disclose to the Drug Enforcement 
Administration, or the DEA, opioid orders that are suspicious because 
of their size, frequency, or patterns. This simple disclosure could 
prevent millions of prescription opioid pills from ending up on the 
black market.
  Unfortunately, current law has inadvertently created a standard that 
is too high for DOJ to meet in order to take immediate action against 
those who fail to make these disclosures to the DEA or who fail to 
adequately protect against diversion.
  For instance, the DEA has told my staff that under current law, in 
order to immediately stop a drug manufacturer or distributor from 
distributing opioids, a pharmacy from dispensing opioids, or a 
practitioner from prescribing opioids, it must prove that the 
distribution, dispensation, or prescription of the drugs directly 
resulted in an immediate and substantial likelihood that death, serious 
bodily harm, or abuse of a controlled substance occurred.
  For this reason, the bill Senator Capito and I are introducing today 
would change the standard in current law to make it easier to 
immediately stop potentially dangerous shipments of prescription 
opioids. It would allow DOJ to take action when it can demonstrate that 
an opioid manufacturer or distributor's lack of control over a 
prescription opioid would likely result in the drugs winding up in the 
hands of someone other than the intended recipient or on the black 
market.
  This change will compel opioid manufacturers and distributors to be 
more vigilant in their efforts to report and stop the delivery of 
suspicious orders of opioids as well as to protect against diversion. 
In the absence of such vigilance, our bill would allow DOJ to 
immediately stop the delivery of opioids.
  Our bill further ensures that bad actors are held accountable by 
establishing backstops and consequences for when opioid manufacturers, 
distributors, dispensers, and prescribers fail to take corrective 
action.
  Under current law, if there is no immediate threat to the public 
health or safety, opioid manufacturers, distributors, dispensers and 
prescribers can submit a corrective action plan to DOJ before their 
registrations can be revoked or suspended. DOJ does not have to accept 
this plan, but if it does, current law does not outline a timeframe by 
which the plan must be fully implemented or consequences for failure to 
do so.
  Given the magnitude of the opioid epidemic, this is unacceptable.
  That is why our bill would require those who manufacture, distribute, 
dispense or prescribe opioids to fully implement any plan that is 
accepted by DOJ within 30 days. Failure to do so will result in the 
immediate suspension of a registration until the reinstated proceedings 
to deny, revoke, or suspend the registration permanently have 
concluded.
  Mr. President, I have been struck by the seemingly countless examples 
of opioid manufacturers and distributors that have done little to 
safeguard

[[Page S1767]]

against diversion that have been raised in hearings, roundtables, and 
in the news over the last several years.
  The example most often cited is that of Kermit, West Virginia, where, 
over a two year period nine million opioids were delivered to a single 
pharmacy. Between 2007 and 2012, 780 million oxycodone and hydrocodone 
pills were delivered to pharmacies throughout that state. This resulted 
in 1,728 fatal overdoses that were largely preventable.
  We cannot allow this to happen again.
  The bill Senator Capito and I are introducing today will strengthen 
current law by providing law enforcement with the additional tools it 
needs to better and more proactively combat the opioid epidemic and 
hold bad actors accountable.
  I hope my colleagues will join us in supporting this important 
legislation.
  Thank you, Mr. President. I yield the floor.-

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