Stopping Suspicious Orders of Opioids Act

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

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.-

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

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.-

Mr. President, I rise today to introduce legislation that would implement the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who are Blind, Visually Impaired, or Otherwise Print Disabled (``Marrakesh Treaty''). I'm pleased that Senators Feinstein, Corker, Menendez, Hatch, Harris and Leahy are joining me as original cosponsors.

The Marrakesh Treaty was signed by the United States in October 2013. It seeks to help address the global ``book famine'' and facilitate access to printed works for visually impaired individuals by providing, with appropriate safeguards, that copyright protection should not impede the creation and distribution of accessible format copies, including the exchange of such copies internationally.

The Marrakesh Treaty Implementation Act represents a consensus approach developed by the Senate Judiciary and Foreign Relations Committees with stakeholders within the publishers, libraries and print disabilities communities, in consultation with the U.S. Patent and Trademark Office and the U.S. Copyright Office as well as other interested industry and public interest stakeholders. I particularly want to commend the National Federation of the Blind, the Association of American Publishers and the Library Copyright Alliance for working with us in reaching an agreement on legislative text and proposed legislative history. We would not be here today without their efforts.

I look forward to working with my colleagues on the Foreign Relations Committee, Chairman Corker and Ranking Member Menendez, on ratification of the Marrakesh Treaty in the Senate, and with Judiciary Committee Ranking Member Feinstein on passing the Marrakesh Treaty Implementation Act.